Ignite Creation Date:
2025-12-24 @ 2:15 PM
Ignite Modification Date:
2025-12-26 @ 12:23 AM
Study NCT ID:
NCT01973595
Status:
COMPLETED
Last Update Posted:
2016-05-26
First Post:
2013-10-15
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Almonds: Digestive Health and Immune Function of Adults and Children
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007249', 'term': 'Inflammation'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'henken@ufl.edu', 'phone': '352-392-1991', 'title': 'Dr. Bobbi Langkamp- Henken', 'phoneExt': '205', 'organization': 'University of Florida'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '14 weeks; pre-baseline (week 0) to final follow up week (week 14)', 'eventGroups': [{'id': 'EG000', 'title': 'Almonds Consumption', 'description': 'Participants were asked to consume 1.5 ounces of almonds or almond paste per day for 3 weeks.\n\nEach group received the almond intervention and the no almond consumption control.\n\nAlmonds: Whole, raw almonds with skin, or whole, raw almonds with skin that have been ground into a paste.', 'otherNumAtRisk': 58, 'otherNumAffected': 0, 'seriousNumAtRisk': 58, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'No Almonds Consumption Control', 'description': 'Participants were asked not to consume almonds for 3 weeks.\n\nEach group received the almond intervention and the no almond consumption control.', 'otherNumAtRisk': 58, 'otherNumAffected': 0, 'seriousNumAtRisk': 58, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Gut Microbiota Community Composition', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Almonds Consumption', 'description': 'Participants were asked to consume 1.5 ounces of almonds or almond paste per day for 3 weeks.\n\nEach group received the almond intervention and the no almond consumption control.\n\nAlmonds: Whole, raw almonds with skin, or whole, raw almonds with skin that have been ground into a paste.'}, {'id': 'OG001', 'title': 'No Almonds Consumption Control', 'description': 'Participants were asked not to consume almonds for 3 weeks.\n\nEach group received the almond intervention and the no almond consumption control.'}], 'classes': [{'title': 'Parents', 'categories': [{'measurements': [{'value': '-.0116', 'spread': '0.162', 'groupId': 'OG000'}, {'value': '-0.407', 'spread': '0.137', 'groupId': 'OG001'}]}]}, {'title': 'Children', 'categories': [{'measurements': [{'value': '-0.161', 'spread': '0.292', 'groupId': 'OG000'}, {'value': '-.0498', 'spread': '0.231', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline #1 (Week 1) to Final #1 (Week 4) of each intervention', 'description': 'The mean of the change between baseline and final time points in stool lactic acid bacteria counts \\[log(CFU)\\] was compared for each study arm.', 'unitOfMeasure': 'log (CFU)', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Stool samples were analyzed only if all 4 were available from each participant. Therefore, only data from 21 parents and 20 children were analyzed.'}, {'type': 'SECONDARY', 'title': 'Inflammatory Status', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Almonds Consumption (Parents)', 'description': 'Parents were asked to consume 1.5 ounces of almonds or almond paste per day for 3 weeks.\n\nEach group received the almond intervention and the no almond consumption control.\n\nAlmonds: Whole, raw almonds with skin, or whole, raw almonds with skin that have been ground into a paste.'}, {'id': 'OG001', 'title': 'No Almonds Consumption Control (Parents)', 'description': 'Parents were asked not to consume almonds for 3 weeks.\n\nEach group received the almond intervention and the no almond consumption control.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '13', 'spread': '0.9', 'groupId': 'OG000'}, {'value': '14', 'spread': '0.9', 'groupId': 'OG001'}]}]}, {'title': 'Final', 'categories': [{'measurements': [{'value': '14', 'spread': '0.9', 'groupId': 'OG000'}, {'value': '14', 'spread': '0.9', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Change between Baseline to Week 4', 'description': 'Levels of inflammatory markers in the blood (IL-6) were compared between baseline and final time points once the participants were on the Almonds intervention.. The data were collected at Baseline and Week four.', 'unitOfMeasure': 'ng/ml', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Parents (Almonds baseline, n=29, final n=29, No almonds baseline n=28, final n= 28; one parent withdrew prior to no almond consumption control intervention) were analyzed for almonds and no almond consumption, no children were included in this analysis.'}, {'type': 'SECONDARY', 'title': 'Gastrointestinal Function', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Almonds Consumption', 'description': 'Participants were asked to consume 1.5 ounces of almonds or almond paste per day for 3 weeks.\n\nEach group received the almond intervention and the no almond consumption control.\n\nAlmonds: Whole, raw almonds with skin, or whole, raw almonds with skin that have been ground into a paste.'}, {'id': 'OG001', 'title': 'No Almond Consumption Control', 'description': 'Participants were asked not to consume almonds for 3 weeks. After a washout period of 4 weeks, they then received the almond intervention diet.\n\nEach group received the almond intervention and the no almond consumption control.'}], 'classes': [{'title': 'Parents Pre-baseline', 'categories': [{'measurements': [{'value': '9.4', 'spread': '0.8', 'groupId': 'OG000'}, {'value': '8.6', 'spread': '0.8', 'groupId': 'OG001'}]}]}, {'title': 'Parents Week 3', 'categories': [{'measurements': [{'value': '9.6', 'spread': '0.8', 'groupId': 'OG000'}, {'value': '10.3', 'spread': '0.8', 'groupId': 'OG001'}]}]}, {'title': 'Children Pre-baseline', 'categories': [{'measurements': [{'value': '6.7', 'spread': '6.7', 'groupId': 'OG000'}, {'value': '6.1', 'spread': '0.5', 'groupId': 'OG001'}]}]}, {'title': 'Children Week 3', 'categories': [{'measurements': [{'value': '7.4', 'spread': '0.5', 'groupId': 'OG000'}, {'value': '6.9', 'spread': '0.5', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-baseline (Week 0) and Week 3 of each intervention', 'description': 'Changes in average number of stools per week were measured using a Daily Questionnaire. Results were compared between treatment periods for each subject/group.', 'unitOfMeasure': 'average stools per week', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': '29 parents and 29 children consumed almonds n=58; one parent-child pair withdrew prior to no almond consumption control intervention n=56; parents and children were analyzed for almonds and no almond consumption.'}, {'type': 'SECONDARY', 'title': 'Diet Quality', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}, {'value': '28', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Almonds Consumption (Parents)', 'description': 'Parents were asked to consume 1.5 ounces of almonds or almond paste per day for 3 weeks.\n\nEach group received the almond intervention and the no almond consumption control.\n\nAlmonds: Whole, raw almonds with skin, or whole, raw almonds with skin that have been ground into a paste.'}, {'id': 'OG001', 'title': 'No Almonds Consumption Control (Parents)', 'description': 'Parents were asked not to consume almonds for 3 weeks.\n\nEach group received the almond intervention and the no almond consumption control.'}, {'id': 'OG002', 'title': 'Almonds Consumption (Children)', 'description': 'Children were asked to consume 0.5 ounces of almonds or almond paste per day for 3 weeks.\n\nEach group received the almond intervention and the no almond consumption control.\n\nAlmonds: Whole, raw almonds with skin, or whole, raw almonds with skin that have been ground into a paste.'}, {'id': 'OG003', 'title': 'No Almonds Consumption Control (Children)', 'description': 'Children were asked not to consume almonds for 3 weeks.\n\nEach group received the almond intervention and the no almond consumption control.'}], 'classes': [{'categories': [{'measurements': [{'value': '61.4', 'spread': '1.4', 'groupId': 'OG000'}, {'value': '53.7', 'spread': '1.8', 'groupId': 'OG001'}, {'value': '61.4', 'spread': '2.2', 'groupId': 'OG002'}, {'value': '53.7', 'spread': '2.6', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Three week almond intervention vs. three week no almond intervention', 'description': 'Three dietary recalls occurred per study arm, and each recall was scored for quality. The quality scores were averaged per arm and then compared between study arms for each subject/group using the Healthy Eating Index-2010.The Healthy Eating Index assesses diet quality based on 12 components, when summed has maximum points of 100 (HEI scale 0-100).\n\nHigh component scores indicate intakes close to the recommended ranges or amounts; low component scores indicate less compliance with the recommended ranges or amounts.\n\nNational averages total score: children: 54.9 \\[4-8 years\\] and adults: 57.4 \\[31-50 years\\])', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': '29 Parents and 29 children were analyzed separately for almonds and no almond consumption; one parent-child pair withdrew prior to no almond consumption control.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Almonds, Then no Almonds (Parents)', 'description': 'Parents were asked to consume 1.5 ounces of almonds or almond paste per day for 3 weeks. After a washout period of 4 weeks, they then received control diet.\n\nAlmonds: Whole, raw almonds with skin, or whole, raw almonds with skin that have been ground into a paste.'}, {'id': 'FG001', 'title': 'No Almonds, Then Almonds (Parents)', 'description': 'Parents were asked not to consume almonds for 3 weeks. After a washout period of 4 weeks, they then received the almond intervention diet.'}, {'id': 'FG002', 'title': 'Almonds, Then no Almonds (Children)', 'description': 'Children were asked to consume 0.5 ounces of almonds or almond paste per day for 3 weeks. After a washout period of 4 weeks, they then received control diet.\n\nAlmonds: Whole, raw almonds with skin, or whole, raw almonds with skin that have been ground into a paste.'}, {'id': 'FG003', 'title': 'No Almonds Then Almonds (Children)', 'description': 'Children were asked not to consume almonds for 3 weeks. After a washout period of 4 weeks, they then received the almond intervention diet.'}], 'periods': [{'title': 'Intervention Phase 1', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '14'}, {'groupId': 'FG002', 'numSubjects': '15'}, {'groupId': 'FG003', 'numSubjects': '14'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '14'}, {'groupId': 'FG002', 'numSubjects': '15'}, {'groupId': 'FG003', 'numSubjects': '14'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}, {'title': 'Washout', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '14'}, {'groupId': 'FG002', 'numSubjects': '15'}, {'groupId': 'FG003', 'numSubjects': '14'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '14'}, {'groupId': 'FG002', 'numSubjects': '14'}, {'groupId': 'FG003', 'numSubjects': '14'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}, {'title': 'Intervention Phase 2', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '14'}, {'groupId': 'FG002', 'numSubjects': '14'}, {'groupId': 'FG003', 'numSubjects': '14'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '14'}, {'groupId': 'FG002', 'numSubjects': '14'}, {'groupId': 'FG003', 'numSubjects': '14'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}, {'value': '14', 'groupId': 'BG003'}, {'value': '58', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Almonds, Then no Almonds (Parents)', 'description': 'Parents were asked to consume 1.5 ounces of almonds or almond paste per day for 3 weeks. After a washout period of 4 weeks, they then received control diet.\n\nAlmonds: Whole, raw almonds with skin, or whole, raw almonds with skin that have been ground into a paste.'}, {'id': 'BG001', 'title': 'No Almonds, Then Almonds (Parents)', 'description': 'Parents were asked not to consume almonds for 3 weeks. After a washout period of 4 weeks, they then received the almond intervention diet.'}, {'id': 'BG002', 'title': 'Almonds, Then no Almonds (Children)', 'description': 'Children were asked to consume 0.5 ounces of almonds or almond paste per day for 3 weeks. After a washout period of 4 weeks, they then received control diet.\n\nAlmonds: Whole, raw almonds with skin, or whole, raw almonds with skin that have been ground into a paste'}, {'id': 'BG003', 'title': 'No Almonds, Then Almonds (Children)', 'description': 'Children were asked not to consume almonds for 3 weeks. After a washout period of 4 weeks, they then received the almond intervention diet.'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}, {'value': '14', 'groupId': 'BG003'}, {'value': '29', 'groupId': 'BG004'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '29', 'groupId': 'BG004'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '38', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}, {'value': '20', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}, {'value': '14', 'groupId': 'BG003'}, {'value': '58', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'Data from parents and children were analyzed separately. All parents and children received both treatments arms.'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 58}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-04', 'completionDateStruct': {'date': '2014-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-04-26', 'studyFirstSubmitDate': '2013-10-15', 'resultsFirstSubmitDate': '2015-11-12', 'studyFirstSubmitQcDate': '2013-10-25', 'lastUpdatePostDateStruct': {'date': '2016-05-26', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2016-03-23', 'studyFirstPostDateStruct': {'date': '2013-10-31', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-04-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Gut Microbiota Community Composition', 'timeFrame': 'Baseline #1 (Week 1) to Final #1 (Week 4) of each intervention', 'description': 'The mean of the change between baseline and final time points in stool lactic acid bacteria counts \\[log(CFU)\\] was compared for each study arm.'}], 'secondaryOutcomes': [{'measure': 'Inflammatory Status', 'timeFrame': 'Change between Baseline to Week 4', 'description': 'Levels of inflammatory markers in the blood (IL-6) were compared between baseline and final time points once the participants were on the Almonds intervention.. The data were collected at Baseline and Week four.'}, {'measure': 'Gastrointestinal Function', 'timeFrame': 'Pre-baseline (Week 0) and Week 3 of each intervention', 'description': 'Changes in average number of stools per week were measured using a Daily Questionnaire. Results were compared between treatment periods for each subject/group.'}, {'measure': 'Diet Quality', 'timeFrame': 'Three week almond intervention vs. three week no almond intervention', 'description': 'Three dietary recalls occurred per study arm, and each recall was scored for quality. The quality scores were averaged per arm and then compared between study arms for each subject/group using the Healthy Eating Index-2010.The Healthy Eating Index assesses diet quality based on 12 components, when summed has maximum points of 100 (HEI scale 0-100).\n\nHigh component scores indicate intakes close to the recommended ranges or amounts; low component scores indicate less compliance with the recommended ranges or amounts.\n\nNational averages total score: children: 54.9 \\[4-8 years\\] and adults: 57.4 \\[31-50 years\\])'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['almonds', 'inflammation', 'immunity', 'gut microbiota', 'stress', 'diet quality'], 'conditions': ['Healthy']}, 'referencesModule': {'references': [{'pmid': '26773784', 'type': 'DERIVED', 'citation': 'Burns AM, Zitt MA, Rowe CC, Langkamp-Henken B, Mai V, Nieves C Jr, Ukhanova M, Christman MC, Dahl WJ. Diet quality improves for parents and children when almonds are incorporated into their daily diet: a randomized, crossover study. Nutr Res. 2016 Jan;36(1):80-9. doi: 10.1016/j.nutres.2015.11.004. Epub 2015 Nov 10.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether incorporating almonds into the diets of families with young children will induce beneficial changes in gastrointestinal function, the fecal microbiota profile, and immune and inflammatory processes of the adults and children resulting in improved quality of life. The investigators anticipate finding an increase in beneficial bacteria, improved intestinal function, and decreased inflammation during the almond intervention.', 'detailedDescription': 'This is a randomized, crossover study. After obtaining informed consent, healthy adults aged 18-40 years with children aged 3-6 years will be randomized to either consume almonds and almond paste during the first arm of the study or during the second arm of the study. During the intervention period, adult participants will consume 1.5 ounces of almonds per day, and children will consume 0.5 ounces of almonds per day for 3 weeks. After a 4-week washout period, participants will be crossed to the other treatment (no almond consumption or almond consumption).\n\nParticipants will complete daily questionnaires throughout the intervention period, and one week before and after each intervention period. Blood samples will be collected from adults at the baseline and final time points of each intervention. Stool samples will be collected during the pre-baseline and final weeks of each intervention. Dietary intake will be assessed weekly during each intervention period. Gastrointestinal symptoms questionnaires will be completed weekly during each intervention.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\nTo participate in the study, adult participants must:\n\n* Be 18 to 40 years old.\n* Have a 3 to 6 year old child that you are willing to enroll in the study.\n* Live with your child for on average at least 6 days of the week.\n* Be willing and able to complete the Informed Consent Form in English.\n* Not be currently pregnant or planning to become pregnant in the next 5 months.\n* Be willing to consume 1.5 ounces of almonds (\\~43 nuts) each day for three weeks.\n* Be willing to feed your child 0.5 ounces of almond paste (\\~2 tablespoons) per day for three weeks.\n* Be willing monitor your child's daily intake over the course of the study.\n* Be willing to provide 4 blood samples, 4 stool samples, and 4 saliva samples over the course of the study.\n* Be willing to assist your child in providing 4 stool samples and 4 saliva samples over the course of the study.\n* Be willing and able to complete daily and weekly questionnaires for you and your child regarding general wellness, bowel function, gastrointestinal symptoms, stress and anxiety, and dietary intake.\n* Must be available for 14 consecutive weeks to participate in the study.\n\nExclusion Criteria:\n\nTo participate in the study, adult and child participants:\n\n* Must not have any known nut or tree nut allergies.\n* Must discontinue any immune-enhancing dietary supplements (e.g., prebiotics and fiber supplements, probiotics, fish oil, vitamin E \\>400% of the Recommended Dietary Allowance (RDA) or \\>60 mg/day, and yogurts with live, active cultures).\n* Must not be currently taking any medications for constipation or diarrhea on a regular basis.\n* Must not be currently taking any large doses of anti-inflammatory drugs (i.e., aspirin in doses \\>600 mg/d) on a regular basis.\n* Must not have received antibiotic therapy or a colonoscopy in the past two months.\n* Must not be currently being treated for or have any of the following physician-diagnosed diseases or conditions: HIV/AIDS; immune modulating diseases (autoimmune disease, hepatitis, cancer); kidney disease; pancreatitis; pulmonary disease; hepatic or biliary disease; or gastrointestinal diseases/conditions such as diverticulitis, ulcerative colitis, Crohn's disease, Celiac disease, short bowel disease, ileostomy, or colostomy, but not including gastroesophageal reflux disease; or have a central venous catheter."}, 'identificationModule': {'nctId': 'NCT01973595', 'briefTitle': 'Almonds: Digestive Health and Immune Function of Adults and Children', 'organization': {'class': 'OTHER', 'fullName': 'University of Florida'}, 'officialTitle': 'Almonds: Digestive Health and Immune Function of Adults and Children: a Randomized Crossover Study', 'orgStudyIdInfo': {'id': '201300475'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Almonds then no almonds', 'description': 'Adults will consume 1.5 ounces of almonds or almond paste per day and children will consume 0.5 ounces of almonds or almond paste per day for 3 weeks.', 'interventionNames': ['Dietary Supplement: Almonds, Then no almonds']}, {'type': 'OTHER', 'label': 'No almonds then almonds', 'description': 'No almonds will be consumed by participants for 3 weeks.', 'interventionNames': ['Other: No Almonds, Then almonds']}], 'interventions': [{'name': 'Almonds, Then no almonds', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Whole, raw almonds with skin, or whole, raw almonds with skin that have been ground into a paste.', 'armGroupLabels': ['Almonds then no almonds']}, {'name': 'No Almonds, Then almonds', 'type': 'OTHER', 'description': 'No almonds will be consumed by participants for 3 weeks.', 'armGroupLabels': ['No almonds then almonds']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32611', 'city': 'Gainesville', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Florida', 'geoPoint': {'lat': 29.65163, 'lon': -82.32483}}], 'overallOfficials': [{'name': 'Bobbi Langkamp-Henken, PhD, RD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Florida'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Florida', 'class': 'OTHER'}, 'collaborators': [{'name': 'Almond Board of California', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}