Snack Foods and Their Impact on Gastrointestinal Microbiology, Function and Symptoms (OptiGut)
3. februar 2020 opdateret af: Professor Kevin Whelan, King's College London
Snack Foods and Their Impact on Gastrointestinal Physiology, Luminal Microbiology and Gastrointestinal Symptoms
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.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
87
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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London, Det Forenede Kongerige, SE1 9NH
- King's College London Waterloo Campus
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år til 45 år (Voksen)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Alle
Beskrivelse
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
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Aktiv komparator: 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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Aktiv komparator: 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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Placebo komparator: 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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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Faecal bifidobacteria
Tidsramme: 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
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Whole gut transit time
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: Baseline
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Measured using the SmartPill wireless motility capsule
|
Baseline
|
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Regional gut pH
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: Day 28
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Measured by 16S community profiling (Illumina Miseq) of bacterial genomic DNA isolated from participant stool samples
|
Day 28
|
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Faecal short-chain fatty acids (SCFA)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: Baseline
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Measured by lyophilization of stool sample
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Baseline
|
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Faecal water
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: week 4
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Gastrointestinal symptoms rating scale (7-day; questionnaire)
|
week 4
|
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Stool frequency
Tidsramme: Week 0
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Bristol stool form scale (7-day; questionnaire)
|
Week 0
|
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Stool frequency
Tidsramme: 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
Tidsramme: Week 0
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7-day food diary
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Week 0
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Dietary intake
Tidsramme: Week 4
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7-day food diary
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Week 4
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Quality of life
Tidsramme: Baseline
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SF-36 questionnaire
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Baseline
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Quality of life
Tidsramme: Day 28
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SF-36 questionnaire
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Day 28
|
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Mood
Tidsramme: Baseline
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Hospital anxiety and depression scale
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Baseline
|
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Mood
Tidsramme: Day 28
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Hospital anxiety and depression scale
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Day 28
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Physical activity
Tidsramme: Baseline
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Recent physical activity questionnaire
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Baseline
|
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Physical activity
Tidsramme: Day 28
|
Recent physical activity questionnaire
|
Day 28
|
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Dietary metabolites (various)
Tidsramme: Baseline
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Measured in blood sample
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Baseline
|
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Dietary metabolites (various)
Tidsramme: 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
Tidsramme: 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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Andre resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Adverse events
Tidsramme: 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
Tidsramme: Day 28
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Questionnaire
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Day 28
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Kevin Whelan, Prof., King's College London
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
27. april 2018
Primær færdiggørelse (Faktiske)
30. september 2019
Studieafslutning (Faktiske)
30. september 2019
Datoer for studieregistrering
Først indsendt
23. juni 2018
Først indsendt, der opfyldte QC-kriterier
9. juli 2018
Først opslået (Faktiske)
10. juli 2018
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
5. februar 2020
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
3. februar 2020
Sidst verificeret
1. februar 2020
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Andre undersøgelses-id-numre
- HR-17/18-5341
Plan for individuelle deltagerdata (IPD)
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