NCT06416254Completed
The Fibre Full Study
The Effects of a Diet Enriched With Dietary Fibre on Glycaemic Response, Gastrointestinal Tolerability, Satiety, and Microbiome Functionality (The Fibre Full Study).
Source: ClinicalTrials.gov · Last updated 7 May 2026
Brief summary (registry, in English)
This study will systematically investigate the effects of a diet with decreased energy density, reduced glycaemic index, and significantly increased dietary fibre, on post-prandial glycaemic response, satiety, gastrointestinal tolerability and gut microbiota composition and function in individuals with excess body weight (Body Mass Index (BMI) 25-35kg/m2). Hypothesis: The investigators hypothesise that a diet enriched in fibre will be beneficial to post-prandial glycaemic response, well tolerated and satiating, as compared to the standard Western-style diet.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 24 (actual)
- First submitted
- 3 May 2024
- Start date
- 28 Mar 2024
- Primary completion date
- 7 Dec 2024
- Lead sponsor
- University College Cork
- Diseases
- Obesity
- NCT number
- NCT06416254
What you commit to
- Study type: Interventional
- Participants enrolled: 24
- From 28 Mar 2024 to the primary completion date, 7 Dec 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Have had antibiotic treatment within three months prior to baseline.
- Are taking a medication that the investigator believes would interfere with the objectives of the study, pose a safety risk, or confound the interpretation of study results; to include: anti-inflammatory drugs, H2 blockers, antacid, proton pump inhibitors, anti-hypertensive medications, corticosteroids, laxatives, enemas, antibiotics, anti-coagulants, immunosuppressant medication. Participants should have a wash-out period of at least two-weeks for each of these medications except for antibiotics, which should not have been taken in the previous three months. Participants taking proton pump inhibitors and medications for chronic conditions (e.g., anti-hypertensive medication) will be allowed onto the study if the dose has been stable for at least two months prior to the study baseline visit.
- Have a history or indication of drug and/or alcohol abuse at the time of enrolment.
- Have experienced major dietary changes within three months prior to the study baseline.
- Have an active gastrointestinal disorder or previous gastrointestinal surgery
- Have a malignant disease or concomitant end-stage organ disease.
- Experience alarm features such as sudden weight loss, rectal bleeding, a recent change in bowel habits, or significant abdominal pain within three months prior to baseline.
- Participants may not be receiving treatment involving experimental drugs.
- If the participant has been in a recent experimental trial, these must have been completed not less than 30 days prior to this study.
Other illness
- Have a clinically diagnosed eating disorder.
- Have a food allergy or intolerance that would preclude study product intake (for example eggs, gluten, nuts, milk or any other food allergy or intolerance)
- Have a significant active and medically-diagnosed acute or chronic co-existing illness including: metabolic, psychiatric, cardiovascular, endocrinological, immunological condition, gastrointestinal disease or any other condition which contraindicates, in the investigator's judgement, entry to the study (such as, diarrhoea, Crohn's disease, ulcerative colitis, irritable bowel syndrome, diverticulosis, stomach or duodenal ulcers, hepatitis A/B/C, HIV, cancer, diabetes etc) or a significant history of such diseases.
- Are severely immunocompromised (e.g., HIV positive, transplant patient, on anti-rejection medications, on a steroid for \>30 days, or chemotherapy or radiotherapy within the last 12 months).
- Have symptomatic respiratory or cardiac illness.
Other
- Pregnant, lactating, menopausal or post-menopausal women, or women who are planning to become pregnant over the study period.
- Have a habitual alcohol consumption of \>2 alcoholic beverages/day (\>28g ethanol daily).
- Follow a vegetarian or vegan diet
- Have a typical fibre intake of \>30g per day
- Plan major lifestyle changes (diet, physical activity, or travel) during the study period.
- Individuals who, in the opinion of the investigator are poor attendees or unlikely for any reason to be able to comply with the study protocol.
- Individuals with pacemakers or implantable cardioverter defibrillators.
- Individuals that regularly undertake rigorous exercise, defined by International Physical Activity Questionnaire with a score within category 3, Health Enhancing Physical Activity (HEPA) Active.
- Individuals who smoke or vape regularly (i.e., daily or habitual use).
Who the study is looking for
- Be willing and able to give written informed consent.
- Be between 18 and 45 years of age
- Have a Body Mass Index (BMI) of 25-34.9kg/m2 (Overweight or Obese Class I)
- Have had a stable body weight (≤5% change over the past three months)
- Be in general good health as determined by the investigator through interview and vital signs (blood pressure, pulse, temperature). Systolic blood pressure less than 160mm Hg and diastolic blood pressure less than 100 mm Hg (defined as Hypertension stage 2).
- Be willing to avoid consuming dietary supplements, prebiotics, probiotics, or fibre-rich supplements within four weeks prior to the baseline visit, and until the end of the study.
- Be willing to avoid physical exercise for the duration of the study (physical exercise defined as any physical activity that is planned to achieve a fitness goal)
- Be willing to consume the investigational products daily for the duration of the study.
Age in the registry: 18 years to 45 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University College Cork Coordinator of this site? Confirm its status | Cork | Ireland | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.