Snack Foods and Their Impact on Gastrointestinal Microbiology, Function and Symptoms (OptiGut)
Snack Foods and Their Impact on Gastrointestinal Physiology, Luminal Microbiology and Gastrointestinal Symptoms
연구 개요
상태
정황
상세 설명
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.
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.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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London, 영국, SE1 9NH
- King's College London Waterloo Campus
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Male or female
- Aged between 18-45 years
- Body mass index (BMI) of 18.5 - 29.9 kg/m2
- Regular consumption of snacks (≥2 per day, excluding fruit and nut snacks)
- Low fibre intake (<22 g/d)
- Willing to follow the protocol and provide consent
Exclusion Criteria:
- Allergy or intolerance to snack ingredients (assessed at screening)
- 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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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활성 비교기: Intervention snack 1
Snack food believed to selectively promote the growth of beneficial bacterial strains in the human colon.
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To be eaten instead of regular snacks twice a day for 4 weeks.
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활성 비교기: Intervention snack 2
Snack food believed to selectively promote the growth of beneficial bacterial strains in the human colon.
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To be eaten instead of regular snacks twice a day for 4 weeks.
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위약 비교기: Control snack
Control snack food reflecting the macro-nutrient profile of a typical UK snack.
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To be eaten instead of regular snacks twice a day for 4 weeks.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Faecal bifidobacteria
기간: Baseline
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Measured by 16S community profiling (Illumina Miseq) of bacterial genomic DNA isolated from participant stool samples
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Baseline
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Faecal bifidobacteria
기간: Day 28
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Measured by 16S community profiling (Illumina Miseq) of bacterial genomic DNA isolated from participant stool samples
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Day 28
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Whole gut transit time
기간: Baseline
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Measured using the SmartPill wireless motility capsule
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Baseline
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Whole gut transit time
기간: Day 28
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Measured using the SmartPill wireless motility capsule
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Day 28
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Regional gut transit time
기간: Baseline
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Measured using the SmartPill wireless motility capsule
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Baseline
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Regional gut transit time
기간: Day 28
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Measured using the SmartPill wireless motility capsule
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Day 28
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Regional gut pH
기간: Baseline
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Measured using the SmartPill wireless motility capsule
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Baseline
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Regional gut pH
기간: Day 28
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Measured using the SmartPill wireless motility capsule
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Day 28
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Faecal gut microbiota (alpha- and beta-diversity)
기간: Baseline
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Measured by 16S community profiling (Illumina Miseq) of bacterial genomic DNA isolated from participant stool samples
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Baseline
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Faecal gut microbiota (alpha- and beta-diversity)
기간: Day 28
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Measured by 16S community profiling (Illumina Miseq) of bacterial genomic DNA isolated from participant stool samples
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Day 28
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Faecal short-chain fatty acids (SCFA)
기간: Baseline
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Measured by gas liquid chromatography of stool sample
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Baseline
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Faecal short-chain fatty acids (SCFA)
기간: Day 28
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Measured by gas liquid chromatography of stool sample
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Day 28
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Faecal water
기간: Baseline
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Measured by lyophilization of stool sample
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Baseline
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Faecal water
기간: Day 28
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Measured by lyophilization of stool sample
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Day 28
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Faecal volatile organic compounds
기간: Baseline
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Measured by gas-chromatography mass-spectrometry of stool samples
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Baseline
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Faecal volatile organic compounds
기간: Day 28
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Measured by gas-chromatography mass-spectrometry of stool samples
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Day 28
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Gut symptoms
기간: Week 0
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Gastrointestinal symptoms rating scale (7-day; questionnaire)
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Week 0
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Gut symptoms
기간: week 4
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Gastrointestinal symptoms rating scale (7-day; questionnaire)
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week 4
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Stool frequency
기간: Week 0
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Bristol stool form scale (7-day; questionnaire)
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Week 0
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Stool frequency
기간: Week 4
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Bristol stool form scale(7-day; questionnaire)
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Week 4
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Dietary intake
기간: Week 0
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7-day food diary
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Week 0
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Dietary intake
기간: Week 4
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7-day food diary
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Week 4
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Quality of life
기간: Baseline
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SF-36 questionnaire
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Baseline
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Quality of life
기간: Day 28
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SF-36 questionnaire
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Day 28
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Mood
기간: Baseline
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Hospital anxiety and depression scale
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Baseline
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Mood
기간: Day 28
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Hospital anxiety and depression scale
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Day 28
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Physical activity
기간: Baseline
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Recent physical activity questionnaire
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Baseline
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Physical activity
기간: Day 28
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Recent physical activity questionnaire
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Day 28
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Dietary metabolites (various)
기간: Baseline
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Measured in blood sample
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Baseline
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Dietary metabolites (various)
기간: Day 28
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Measured in blood sample
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Day 28
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Particle size of masticated snack foods
기간: Day 28
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Mechanical sieving and laser diffraction of masticated snack foods
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Day 28
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기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Adverse events
기간: From baseline - day 28
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Interview-administered questionnaire
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From baseline - day 28
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Acceptability of snack products
기간: Day 28
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Questionnaire
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Day 28
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공동 작업자 및 조사자
수사관
- 수석 연구원: Kevin Whelan, Prof., King's College London
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .