The Fibre Full Study

Launched by UNIVERSITY COLLEGE CORK · May 14, 2024

Keywords

ClinConnect Summary

The Fibre Full Study is looking at how a special high-fiber diet can help people who are overweight or mildly obese. Researchers want to see if this diet, which has less energy and a lower glycaemic index (which means it affects blood sugar levels less), can improve how people feel after eating, help them feel full, and support a healthy gut. They believe that eating more fiber will be better for these individuals compared to a typical Western diet.

To participate, you need to be between 18 and 45 years old and have a body mass index (BMI) between 25 and 34.9, which means you are considered overweight or mildly obese. You should also be in generally good health and not planning to make major lifestyle changes during the study. Participants will need to avoid exercise and certain dietary supplements for a period before and during the study. If you qualify and decide to take part, you'll be expected to follow the study's diet plan daily and attend regular check-ins to monitor your health and progress.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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.
• Exclusion Criteria:
• • Pregnant, lactating, menopausal or post-menopausal women, or women who are planning to become pregnant over the study period.
• • 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 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
• • Have experienced major dietary changes within three months prior to the study baseline.
• • Plan major lifestyle changes (diet, physical activity, or travel) during the study period.
• • 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 an active gastrointestinal disorder or previous gastrointestinal surgery
• • 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 a malignant disease or concomitant end-stage organ disease.
• • Have symptomatic respiratory or cardiac illness.
• • 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.
• • 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.
• • 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.
• • 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).

Trial Officials