Snack Foods and Their Impact on Gastrointestinal Microbiology, Function and Symptoms

NCT ID: NCT03581812

Last Updated: 2020-02-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

87 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-04-27

Study Completion Date

2019-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Human Microbiome Eating Behavior

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Intervention snack 1

Snack food believed to selectively promote the growth of beneficial bacterial strains in the human colon.

Group Type ACTIVE_COMPARATOR

Intervention snack 1

Intervention Type DIETARY_SUPPLEMENT

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.

Group Type ACTIVE_COMPARATOR

Intervention snack 2

Intervention Type DIETARY_SUPPLEMENT

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.

Group Type PLACEBO_COMPARATOR

Control snack

Intervention Type DIETARY_SUPPLEMENT

To be eaten instead of regular snacks twice a day for 4 weeks.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Intervention snack 1

To be eaten instead of regular snacks twice a day for 4 weeks.

Intervention Type DIETARY_SUPPLEMENT

Intervention snack 2

To be eaten instead of regular snacks twice a day for 4 weeks.

Intervention Type DIETARY_SUPPLEMENT

Control snack

To be eaten instead of regular snacks twice a day for 4 weeks.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Queen Mary University of London

OTHER

Sponsor Role collaborator

University of Liverpool

OTHER

Sponsor Role collaborator

King's College London

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Professor Kevin Whelan

Professor of Dietetics

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Kevin Whelan, Prof.

Role: PRINCIPAL_INVESTIGATOR

King's College London

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

King's College London Waterloo Campus

London, , United Kingdom

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United Kingdom

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 36130222 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

HR-17/18-5341

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Cereals and Intestinal Function
NCT04019457 COMPLETED NA
Particle Size Project
NCT05091801 COMPLETED NA