Ignite Creation Date:
2025-12-26 @ 11:13 PM
Ignite Modification Date:
2026-02-04 @ 11:42 AM
Study NCT ID:
NCT03581812
Status:
COMPLETED
Last Update Posted:
2020-02-05
First Post:
2018-06-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Snack Foods and Their Impact on Gastrointestinal Microbiology, Function and Symptoms
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005247', 'term': 'Feeding Behavior'}], 'ancestors': [{'id': 'D001522', 'term': 'Behavior, Animal'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 87}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-04-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-02', 'completionDateStruct': {'date': '2019-09-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-02-03', 'studyFirstSubmitDate': '2018-06-23', 'studyFirstSubmitQcDate': '2018-07-09', 'lastUpdatePostDateStruct': {'date': '2020-02-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-07-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-09-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Adverse events', 'timeFrame': 'From baseline - day 28', 'description': 'Interview-administered questionnaire'}, {'measure': 'Acceptability of snack products', 'timeFrame': 'Day 28', 'description': 'Questionnaire'}], 'primaryOutcomes': [{'measure': 'Faecal bifidobacteria', 'timeFrame': 'Baseline', 'description': 'Measured by 16S community profiling (Illumina Miseq) of bacterial genomic DNA isolated from participant stool samples'}, {'measure': 'Faecal bifidobacteria', 'timeFrame': 'Day 28', 'description': 'Measured by 16S community profiling (Illumina Miseq) of bacterial genomic DNA isolated from participant stool samples'}], 'secondaryOutcomes': [{'measure': 'Whole gut transit time', 'timeFrame': 'Baseline', 'description': 'Measured using the SmartPill wireless motility capsule'}, {'measure': 'Whole gut transit time', 'timeFrame': 'Day 28', 'description': 'Measured using the SmartPill wireless motility capsule'}, {'measure': 'Regional gut transit time', 'timeFrame': 'Baseline', 'description': 'Measured using the SmartPill wireless motility capsule'}, {'measure': 'Regional gut transit time', 'timeFrame': 'Day 28', 'description': 'Measured using the SmartPill wireless motility capsule'}, {'measure': 'Regional gut pH', 'timeFrame': 'Baseline', 'description': 'Measured using the SmartPill wireless motility capsule'}, {'measure': 'Regional gut pH', 'timeFrame': 'Day 28', 'description': 'Measured using the SmartPill wireless motility capsule'}, {'measure': 'Faecal gut microbiota (alpha- and beta-diversity)', 'timeFrame': 'Baseline', 'description': 'Measured by 16S community profiling (Illumina Miseq) of bacterial genomic DNA isolated from participant stool samples'}, {'measure': 'Faecal gut microbiota (alpha- and beta-diversity)', 'timeFrame': 'Day 28', 'description': 'Measured by 16S community profiling (Illumina Miseq) of bacterial genomic DNA isolated from participant stool samples'}, {'measure': 'Faecal short-chain fatty acids (SCFA)', 'timeFrame': 'Baseline', 'description': 'Measured by gas liquid chromatography of stool sample'}, {'measure': 'Faecal short-chain fatty acids (SCFA)', 'timeFrame': 'Day 28', 'description': 'Measured by gas liquid chromatography of stool sample'}, {'measure': 'Faecal water', 'timeFrame': 'Baseline', 'description': 'Measured by lyophilization of stool sample'}, {'measure': 'Faecal water', 'timeFrame': 'Day 28', 'description': 'Measured by lyophilization of stool sample'}, {'measure': 'Faecal volatile organic compounds', 'timeFrame': 'Baseline', 'description': 'Measured by gas-chromatography mass-spectrometry of stool samples'}, {'measure': 'Faecal volatile organic compounds', 'timeFrame': 'Day 28', 'description': 'Measured by gas-chromatography mass-spectrometry of stool samples'}, {'measure': 'Gut symptoms', 'timeFrame': 'Week 0', 'description': 'Gastrointestinal symptoms rating scale (7-day; questionnaire)'}, {'measure': 'Gut symptoms', 'timeFrame': 'week 4', 'description': 'Gastrointestinal symptoms rating scale (7-day; questionnaire)'}, {'measure': 'Stool frequency', 'timeFrame': 'Week 0', 'description': 'Bristol stool form scale (7-day; questionnaire)'}, {'measure': 'Stool frequency', 'timeFrame': 'Week 4', 'description': 'Bristol stool form scale(7-day; questionnaire)'}, {'measure': 'Dietary intake', 'timeFrame': 'Week 0', 'description': '7-day food diary'}, {'measure': 'Dietary intake', 'timeFrame': 'Week 4', 'description': '7-day food diary'}, {'measure': 'Quality of life', 'timeFrame': 'Baseline', 'description': 'SF-36 questionnaire'}, {'measure': 'Quality of life', 'timeFrame': 'Day 28', 'description': 'SF-36 questionnaire'}, {'measure': 'Mood', 'timeFrame': 'Baseline', 'description': 'Hospital anxiety and depression scale'}, {'measure': 'Mood', 'timeFrame': 'Day 28', 'description': 'Hospital anxiety and depression scale'}, {'measure': 'Physical activity', 'timeFrame': 'Baseline', 'description': 'Recent physical activity questionnaire'}, {'measure': 'Physical activity', 'timeFrame': 'Day 28', 'description': 'Recent physical activity questionnaire'}, {'measure': 'Dietary metabolites (various)', 'timeFrame': 'Baseline', 'description': 'Measured in blood sample'}, {'measure': 'Dietary metabolites (various)', 'timeFrame': 'Day 28', 'description': 'Measured in blood sample'}, {'measure': 'Particle size of masticated snack foods', 'timeFrame': 'Day 28', 'description': 'Mechanical sieving and laser diffraction of masticated snack foods'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Gut Microbiota', 'Microbiome', 'Gut Health', 'Snack'], 'conditions': ['Human Microbiome', 'Eating Behavior']}, 'referencesModule': {'references': [{'pmid': '36130222', 'type': 'DERIVED', 'citation': 'Creedon AC, Dimidi E, Hung ES, Rossi M, Probert C, Grassby T, Miguens-Blanco J, Marchesi JR, Scott SM, Berry SE, Whelan K. The impact of almonds and almond processing on gastrointestinal physiology, luminal microbiology, and gastrointestinal symptoms: a randomized controlled trial and mastication study. Am J Clin Nutr. 2022 Dec 19;116(6):1790-1804. doi: 10.1093/ajcn/nqac265.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the impact of replacing usual snacks with alternative snack foods on gut health in a population of habitual snackers with low fibre intake.', 'detailedDescription': 'Diet is a crucial target for the improvement of human health. In the modern world, diets are diverse and diet related diseases are becoming more and more common. In particular, it is becoming increasingly apparent that the bacteria that live in the gut are strongly linked to both diet and health. Bacteria in the gut can be beneficial or harmful, and the health of the gut relies on the beneficial bacteria outnumbering the harmful ones. Diet has a great impact on the bacterial composition of the gut. In turn, the gut bacteria play diverse roles in human health, influencing not only the gut but also the health of the immune system, heart and brain. Therefore, optimising the composition of the gut bacterial is vital to human health and wellbeing.\n\nIt has been shown that snacks between meals contributes 420 - 480 calories per day, almost a quarter of the recommended intake. Therefore, snack choices are an area of diet and lifestyle that have the potential to influence diet and in turn the health of our gut and gut bacteria. We would like to assess the effect of replacing usual snacks with alternative snack foods that we believe have benefits for gut health.\n\nThe primary aim of the study is to investigate whether the replacement of usual snacks has an effect on gut bacterial composition, specifically the abundance of Bifidobacteria. Secondary aims include the effect of the intervention snacks on additional measures of gut health such as gut transit time, the frequency and consistency of bowel movements and gut symptoms e.g. heartburn, nausea, belching etc. The effect of snack foods on metabolites in the blood (e.g. glucose, insulin, lipids) will also be determined. Finally the impact of snack replacement on mood and quality of life will be assessed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female\n* Aged between 18-45 years\n* Body mass index (BMI) of 18.5 - 29.9 kg/m2\n* Regular consumption of snacks (≥2 per day, excluding fruit and nut snacks)\n* Low fibre intake (\\<22 g/d)\n* Willing to follow the protocol and provide consent\n\nExclusion Criteria:\n\n* Allergy or intolerance to snack ingredients (assessed at screening)\n* Dislike of study snacks\n* Regular consumption of intervention foods as snacks (twice a day in last month)\n* Diabetes\n* Major active psychiatric conditions (e.g. schizophrenia) or current eating disorder\n* Active treatment for cancer in the last year\n* Severe renal, cardiac or pulmonary disease or any other chronic medical condition\n* Severe oesophagitis, gastritis or duodenitis\n* Active diverticulitis or intestinal/colonic strictures\n* Crohns disease or Ulcerative colitis\n* Abdominal surgery (except appendicectomy or cholecystectomy)\n* Irritable bowel syndrome\n* Functional constipation\n* Functional diarrhoea\n* Antibiotics (past 4 weeks)\n* Ongoing therapy with drugs affecting gastrointestinal motility\n* Use of medical devices (Pacemakers, infusion pumps, insulin pumps)\n* Women who are pregnant/lactating/planning pregnancy\n* Recent/ongoing consumption of probiotics/prebiotics (past 4 weeks)\n* Ongoing abuse of alcohol/drugs/other medication\n* Very high physical activity levels\n* Unexplained/unintentional weight loss in the past 6 months'}, 'identificationModule': {'nctId': 'NCT03581812', 'acronym': 'OptiGut', 'briefTitle': 'Snack Foods and Their Impact on Gastrointestinal Microbiology, Function and Symptoms', 'organization': {'class': 'OTHER', 'fullName': "King's College London"}, 'officialTitle': 'Snack Foods and Their Impact on Gastrointestinal Physiology, Luminal Microbiology and Gastrointestinal Symptoms', 'orgStudyIdInfo': {'id': 'HR-17/18-5341'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Intervention snack 1', 'description': 'Snack food believed to selectively promote the growth of beneficial bacterial strains in the human colon.', 'interventionNames': ['Dietary Supplement: Intervention snack 1']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Intervention snack 2', 'description': 'Snack food believed to selectively promote the growth of beneficial bacterial strains in the human colon.', 'interventionNames': ['Dietary Supplement: Intervention snack 2']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control snack', 'description': 'Control snack food reflecting the macro-nutrient profile of a typical UK snack.', 'interventionNames': ['Dietary Supplement: Control snack']}], 'interventions': [{'name': 'Intervention snack 1', 'type': 'DIETARY_SUPPLEMENT', 'description': 'To be eaten instead of regular snacks twice a day for 4 weeks.', 'armGroupLabels': ['Intervention snack 1']}, {'name': 'Intervention snack 2', 'type': 'DIETARY_SUPPLEMENT', 'description': 'To be eaten instead of regular snacks twice a day for 4 weeks.', 'armGroupLabels': ['Intervention snack 2']}, {'name': 'Control snack', 'type': 'DIETARY_SUPPLEMENT', 'description': 'To be eaten instead of regular snacks twice a day for 4 weeks.', 'armGroupLabels': ['Control snack']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'SE1 9NH', 'city': 'London', 'country': 'United Kingdom', 'facility': "King's College London Waterloo Campus", 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'overallOfficials': [{'name': 'Kevin Whelan, Prof.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "King's College London"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "King's College London", 'class': 'OTHER'}, 'collaborators': [{'name': 'Queen Mary University of London', 'class': 'OTHER'}, {'name': 'University of Liverpool', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Dietetics', 'investigatorFullName': 'Professor Kevin Whelan', 'investigatorAffiliation': "King's College London"}}}}