Ignite Creation Date:
2025-12-26 @ 1:16 PM
Ignite Modification Date:
2025-12-29 @ 4:28 PM
Study NCT ID:
NCT03233906
Status:
UNKNOWN
Last Update Posted:
2018-05-11
First Post:
2017-07-17
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effects of Chia on Overweight/Obese Women
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}, {'id': 'D005247', 'term': 'Feeding Behavior'}], 'ancestors': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001522', 'term': 'Behavior, Animal'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Human subjects- females (18-45 y.o.) with a BMI greater than or equal to 26.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2017-05-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-05', 'completionDateStruct': {'date': '2018-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-05-08', 'studyFirstSubmitDate': '2017-07-17', 'studyFirstSubmitQcDate': '2017-07-27', 'lastUpdatePostDateStruct': {'date': '2018-05-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-07-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Fasting plasma glucose', 'timeFrame': 'baseline', 'description': '12-hour fasting plasma glucose levels will be assessed using a glucometer'}, {'measure': 'Waist Circumference', 'timeFrame': 'baseline', 'description': 'waist circumference will be measured for each participant'}, {'measure': 'Caloric intake', 'timeFrame': 'baseline', 'description': '9, 3-day diet journals will be collected using a paper method'}, {'measure': 'Serotonin', 'timeFrame': 'baseline', 'description': 'Urine serotonin levels will be assessed'}, {'measure': 'Body Weight', 'timeFrame': 'Baseline', 'description': 'Tanita scale'}, {'measure': 'Body Mass Index', 'timeFrame': 'Baseline', 'description': 'Tanita sclae'}, {'measure': 'Body Fat Percentage', 'timeFrame': 'Baseline', 'description': 'Tanita scale'}, {'measure': 'Fasting plasma glucose', 'timeFrame': 'week 4', 'description': '2-hour fasting plasma glucose levels will be assessed using a glucometer'}, {'measure': 'Fasting plasma glucose', 'timeFrame': 'week 8', 'description': '2-hour fasting plasma glucose levels will be assessed using a glucometer'}, {'measure': 'Waist Circumference', 'timeFrame': 'week 4', 'description': 'waist circumference will be measured for each participant'}, {'measure': 'Waist Circumference', 'timeFrame': 'week 8', 'description': 'waist will be measured for each participant'}, {'measure': 'Caloric intake', 'timeFrame': 'week 4', 'description': '9, 3-day diet journals will be collected using a paper method'}, {'measure': 'Caloric intake', 'timeFrame': 'week 8', 'description': '9, 3-day diet journals will be collected using a paper method'}, {'measure': 'Serotonin', 'timeFrame': 'week 4', 'description': 'Urine serotonin levels will be assessed'}, {'measure': 'Serotonin', 'timeFrame': 'week 8', 'description': 'Urine serotonin levels will be assessed'}, {'measure': 'Body Weight', 'timeFrame': 'week 4', 'description': 'tanita scale'}, {'measure': 'Body weight', 'timeFrame': 'week 8', 'description': 'tanita scale'}, {'measure': 'Body mass index', 'timeFrame': 'week 4', 'description': 'tanita scale'}, {'measure': 'body mass index', 'timeFrame': 'week 8', 'description': 'tanita scale'}, {'measure': 'Body fat percentage', 'timeFrame': 'week 4', 'description': 'tanita scale'}, {'measure': 'Body fat percentage', 'timeFrame': 'week 8', 'description': 'tanita scale'}, {'measure': 'Hip Circumference', 'timeFrame': 'Baseline', 'description': 'Hip Circumference will be measured for each participant'}, {'measure': 'Hip Circumference', 'timeFrame': 'week 4', 'description': 'Hip Circumference will be measured for each participant'}, {'measure': 'Hip Circumference', 'timeFrame': 'week 8', 'description': 'Hip Circumference will be measured for each participant'}], 'secondaryOutcomes': [{'measure': 'Blood Pressure', 'timeFrame': 'baseline', 'description': 'Blood pressure will be taken using an automatic blood pressure machine'}, {'measure': 'Blood Pressure', 'timeFrame': 'week 4', 'description': 'Blood pressure will be taken using an automatic blood pressure machine'}, {'measure': 'Blood Pressure', 'timeFrame': 'week 8', 'description': 'Blood pressure will be taken using an automatic blood pressure machine'}, {'measure': 'Joint Pain', 'timeFrame': 'baseline', 'description': 'Joint pain will be assessed using The WOMAC (Western Ontario and McMaster Universities) Index of Osteoarthritis'}, {'measure': 'Joint Pain', 'timeFrame': 'week 4', 'description': 'Joint pain will be assessed using The WOMAC (Western Ontario and McMaster Universities) Index of Osteoarthritis'}, {'measure': 'Joint Pain', 'timeFrame': 'week 8', 'description': 'Joint pain will be assessed using The WOMAC (Western Ontario and McMaster Universities) Index of Osteoarthritis'}, {'measure': 'Mood', 'timeFrame': 'Baseline', 'description': 'Major Depression Inventory'}, {'measure': 'Mood', 'timeFrame': 'week 4', 'description': 'Major Depression Inventory'}, {'measure': 'Mood', 'timeFrame': 'week 8', 'description': 'Major Depression Inventory'}, {'measure': 'Physical Activity', 'timeFrame': 'Baseline', 'description': 'INTERNATIONAL PHYSICAL ACTIVITY QUESTIONNAIRE (August 2002) SHORT LAST 7 DAYS SELF-ADMINISTERED FORMAT'}, {'measure': 'Physical Activity', 'timeFrame': 'week 4', 'description': 'INTERNATIONAL PHYSICAL ACTIVITY QUESTIONNAIRE (August 2002) SHORT LAST 7 DAYS SELF-ADMINISTERED FORMAT'}, {'measure': 'Physical Activity', 'timeFrame': 'week 8', 'description': 'INTERNATIONAL PHYSICAL ACTIVITY QUESTIONNAIRE (August 2002) SHORT LAST 7 DAYS SELF-ADMINISTERED FORMAT'}, {'measure': 'Sleep Quality', 'timeFrame': 'Baseline', 'description': 'Measuring sleep quality using the Pittsburgh Sleep Quality Index'}, {'measure': 'Sleep Quality', 'timeFrame': 'week 4', 'description': 'Measuring sleep quality using the Pittsburgh Sleep Quality Index'}, {'measure': 'Sleep Quality', 'timeFrame': 'week 8', 'description': 'Measuring sleep quality using the Pittsburgh Sleep Quality Index'}, {'measure': 'Fat mass', 'timeFrame': 'Baseline', 'description': 'using a tanita scale'}, {'measure': 'Fat mass', 'timeFrame': 'week 4', 'description': 'using a tanita scale'}, {'measure': 'Fat mass', 'timeFrame': 'week 8', 'description': 'using a tanita scale'}, {'measure': 'Fat Free Mass', 'timeFrame': 'Baseline', 'description': 'using a tanita scale'}, {'measure': 'Fat Free Mass', 'timeFrame': 'week 4', 'description': 'using a tanita scale'}, {'measure': 'Fat Free Mass', 'timeFrame': 'week 8', 'description': 'using a tanita scale'}, {'measure': 'Total body water', 'timeFrame': 'Baseline', 'description': 'using a tanita scale'}, {'measure': 'Total body water', 'timeFrame': 'week 4', 'description': 'using a tanita scale'}, {'measure': 'Total body water', 'timeFrame': 'week 8', 'description': 'using a tanita scale'}, {'measure': 'Macro nutrient intake', 'timeFrame': 'Baseline', 'description': '3, 3-day diet journals will be collected using a paper method'}, {'measure': 'Macro nutrient intake', 'timeFrame': 'week 4', 'description': '3, 3-day diet journals will be collected using a paper method'}, {'measure': 'Macro nutrient intake', 'timeFrame': 'week 8', 'description': '3, 3-day diet journals will be collected using a paper method'}, {'measure': 'Micronutrient intake', 'timeFrame': 'Baseline', 'description': '3, 3-day diet journals will be collected using a paper method'}, {'measure': 'Micronutrient intake', 'timeFrame': 'week 4', 'description': '3, 3-day diet journals will be collected using a paper method'}, {'measure': 'Micronutrient intake', 'timeFrame': 'week 8', 'description': '3, 3-day diet journals will be collected using a paper method'}, {'measure': 'Dietary intake Satiety', 'timeFrame': 'Baseline', 'description': '3, 3-day diet journals will be collected using a paper method'}, {'measure': 'Dietary intake Satiety', 'timeFrame': 'week 4', 'description': '3, 3-day diet journals will be collected using a paper method'}, {'measure': 'Dietary intake Satiety', 'timeFrame': 'week 8', 'description': '3, 3-day diet journals will be collected using a paper method'}, {'measure': 'Dietary intake displacement', 'timeFrame': 'Baseline', 'description': '3, 3-day diet journals will be collected using a paper method'}, {'measure': 'Dietary intake displacement', 'timeFrame': 'week 4', 'description': '3, 3-day diet journals will be collected using a paper method'}, {'measure': 'Dietary intake displacement', 'timeFrame': 'week 8', 'description': '3, 3-day diet journals will be collected using a paper method'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Obesity', 'Eating Behavior', 'Mood', 'Glucose', 'Dietary Modification']}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to examine the effect of chia seed consumption on body composition, blood pressure, blood glucose, satiety, mood, joint pain, and dietary displacement in overweight and obese females (18-45years). It is hypothesized that consuming chia seeds will bring about a positive change in body composition (lower % body fat), satiety, mood, joint pain, and blood pressure, lower blood glucose levels, increased fiber and improved nutrient intake, in overweight/ obese females.', 'detailedDescription': 'Specific Objectives: 1. Determine if chia seed diet addition of 10% of Kcals (CHIA) positively changes body composition in young, healthy, overweight/obese people (Tanita scale). A) Determine if CHIA will decrease blood pressure (monitor). 2. Determine if CHIA will decrease blood glucose (draw) 3. Determine if CHIA increases satiety and improves diet (recordings). 4. Determine if CHIA will decrease joint pain (questionnaire). 5. Determine if CHIA will increase positive mood changes (questionnaires) and increase blood serotonin levels (draw).'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* are a female.\n* are between the ages of 18 and 45.\n* are not averse to consuming chia seeds on a regular basis (at least six weeks).\n* have not taken any medication for any chronic disease (heart, diabetes, cancer) for twelve weeks.\n* have not taken any steroid or hormone medication in the last eight weeks, excluding birth control pills...\n* do not consume excess amounts of nuts and seeds. - do not consume alcohol on a regular basis.\n* are not currently on a diet plan.\n* are not pregnant or plan to become pregnant.\n\nExclusion Criteria:\n\n* are a child, teenager, woman, or male younger than 18 or older than 45.\n* eat large quantities of chia seeds on a regular basis.\n* are taking any steroid or hormone medication (other than birth control pills). - are taking laxatives or fiber containing supplements on a regular basis.\n* are pregnant or become pregnant.\n* are currently on a diet plan.\n* have a known allergy to seeds.\n* consume excess amounts of seeds or nuts.\n* consume alcohol on a regular basis.\n* have a pacemaker or metal pins or plates in the body.'}, 'identificationModule': {'nctId': 'NCT03233906', 'briefTitle': 'The Effects of Chia on Overweight/Obese Women', 'organization': {'class': 'OTHER', 'fullName': 'California State Polytechnic University, Pomona'}, 'officialTitle': 'Effects of Chia Seed Consumption on Body Composition, Blood Pressure, Blood Glucose, Satiety, Diet Displacement, Joint Pain, Mood and Serotonin Levels in Young, Healthy, Overweight/Obese Females', 'orgStudyIdInfo': {'id': 'IRB-16-188'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Chia Seeds', 'description': '10% of a participants total kcal estimated needs given in chia seeds everyday for 8 weeks.', 'interventionNames': ['Dietary Supplement: Chia Seeds- Salvia Hispanica']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Habitual diet with avoidance of high fiber and high omega-3 fatty acid foods.'}], 'interventions': [{'name': 'Chia Seeds- Salvia Hispanica', 'type': 'DIETARY_SUPPLEMENT', 'description': "Chia seed added-10% of kcals and a no-chia control diet. 10% will be calculated using the following formula: Harris-Benedict equation multiplied by the activity factor of 1.2, 1.375, and 1.55 depending on each participant's activity level based on the information provided on the initial screening form.", 'armGroupLabels': ['Chia Seeds']}]}, 'contactsLocationsModule': {'locations': [{'zip': '91766', 'city': 'Pomona', 'state': 'California', 'country': 'United States', 'facility': 'California State Polytechnic University, Pomona', 'geoPoint': {'lat': 34.05529, 'lon': -117.75228}}], 'overallOfficials': [{'name': 'Bonny Burns-Whitmore, DrPh, RD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'California State Polytechnic University, Pomona'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'California State Polytechnic University, Pomona', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Graduate Student, Human Nutrition and Food Science', 'investigatorFullName': 'Desiree Vera', 'investigatorAffiliation': 'California State Polytechnic University, Pomona'}}}}