Snack Foods and Their Impact on Gastrointestinal Microbiology, Function and Symptoms
NCT ID: NCT03581812
Last Updated: 2020-02-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
87 participants
INTERVENTIONAL
2018-04-27
2019-09-30
Brief Summary
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Detailed Description
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It 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.
The 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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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Intervention snack 1
Snack food believed to selectively promote the growth of beneficial bacterial strains in the human colon.
Intervention snack 1
To be eaten instead of regular snacks twice a day for 4 weeks.
Intervention snack 2
Snack food believed to selectively promote the growth of beneficial bacterial strains in the human colon.
Intervention snack 2
To be eaten instead of regular snacks twice a day for 4 weeks.
Control snack
Control snack food reflecting the macro-nutrient profile of a typical UK snack.
Control snack
To be eaten instead of regular snacks twice a day for 4 weeks.
Interventions
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Intervention snack 1
To be eaten instead of regular snacks twice a day for 4 weeks.
Intervention snack 2
To be eaten instead of regular snacks twice a day for 4 weeks.
Control snack
To be eaten instead of regular snacks twice a day for 4 weeks.
Eligibility Criteria
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Inclusion Criteria
* Aged between 18-45 years
* Body mass index (BMI) of 18.5 - 29.9 kg/m2
* Regular consumption of snacks (ā„2 per day, excluding fruit and nut snacks)
* Low fibre intake (\<22 g/d)
* Willing to follow the protocol and provide consent
Exclusion Criteria
* Dislike of study snacks
* Regular consumption of intervention foods as snacks (twice a day in last month)
* Diabetes
* Major active psychiatric conditions (e.g. schizophrenia) or current eating disorder
* Active treatment for cancer in the last year
* Severe renal, cardiac or pulmonary disease or any other chronic medical condition
* Severe oesophagitis, gastritis or duodenitis
* Active diverticulitis or intestinal/colonic strictures
* Crohns disease or Ulcerative colitis
* Abdominal surgery (except appendicectomy or cholecystectomy)
* Irritable bowel syndrome
* Functional constipation
* Functional diarrhoea
* Antibiotics (past 4 weeks)
* Ongoing therapy with drugs affecting gastrointestinal motility
* Use of medical devices (Pacemakers, infusion pumps, insulin pumps)
* Women who are pregnant/lactating/planning pregnancy
* Recent/ongoing consumption of probiotics/prebiotics (past 4 weeks)
* Ongoing abuse of alcohol/drugs/other medication
* Very high physical activity levels
* Unexplained/unintentional weight loss in the past 6 months
18 Years
45 Years
ALL
Yes
Sponsors
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Queen Mary University of London
OTHER
University of Liverpool
OTHER
King's College London
OTHER
Responsible Party
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Professor Kevin Whelan
Professor of Dietetics
Principal Investigators
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Kevin Whelan, Prof.
Role: PRINCIPAL_INVESTIGATOR
King's College London
Locations
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King's College London Waterloo Campus
London, , United Kingdom
Countries
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References
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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.
Other Identifiers
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HR-17/18-5341
Identifier Type: -
Identifier Source: org_study_id
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