Assess the Effect of a Whole Fruit Powder on Gut Microbiome Function on Overweight & Obese Adults

Launched by UNIVERSITY COLLEGE CORK · Feb 2, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at how freeze-dried blueberry powder affects the gut microbiome, which is the community of bacteria in our digestive system, in overweight and obese adults. The main questions the researchers want to answer are whether taking this blueberry powder can help reduce body weight and if it can change how the gut microbiome functions. Participants will mix a sachet of the blueberry powder or a placebo (a substance with no active ingredients) into their meals daily for 56 days. They will also attend four visits over 14 weeks to check on their health and any changes.

To be eligible for this study, participants need to be adults aged 50 to 65 years with a body mass index (BMI) over 27, which indicates they are overweight or obese. They should also be generally healthy and willing to consume the study product every day. However, individuals who are pregnant, breastfeeding, have certain medical conditions, or have recently changed their diet significantly will not be able to participate. If you join the study, you’ll help researchers learn more about how fruits like blueberries could play a role in weight management and gut health.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Be able to give written informed consent.
• • Adults between 50 to 65 years inclusive.
• • Has a BMI \> 27 kg/m2.
• • Low fibre diet, \<18 g/day.
• • Is in general good health, as determined by the investigator.
• • Willing to consume the Study Product daily for the duration of the study.
• Exclusion Criteria:
• • Participants who are pregnant or wish to become pregnant during the study, or who are currently breastfeeding.
• • Participants currently of childbearing potential, but not using continuous effective method of contraception.
• • Metabolic disease including diabetes.
• • Participants has acute or chronic gastrointestinal and/or infective disease (i.e., coeliac disease, diarrhoea, Crohn's disease, ulcerative colitis, irritable bowel syndrome, diverticulosis, stomach or duodenal ulcers, hepatitis, HIV, cancer, etc.), or with a history of such diseases.
• • Have a significant acute or chronic coexisting illness such as uncontrolled hypertension, uncontrolled hyperlipidaemia, hypercoagulation, inflammatory disorders, or any condition which contraindicates, in the investigator's judgement, entry to the study.
• • Smoking more than 5 cigarettes per day.
• • Participant has a history of drug and/or alcohol abuse at the time of enrolment (Drinks more than nationally recommended units per week (\>11 units for women; \>17 units for men); alcohol/substance abuse disorder).
• • Reported change in diet 30 days prior to Visit 2.
• • Participants who have taken oral antibiotics 12 weeks prior to visit 2.
• • Change in supplements, or major changes in lifestyle (i.e., diet, dieting, exercise level, travelling) for duration of the study.
• • Has a malignant disease or any concomitant end-stage organ disease, and are severely immunocompromised (HIV positive, transplant patient, on antirejection medications, or chemotherapy or radiotherapy which, in the Investigator's judgment, contraindicates participation in the study.
• • Is hypersensitive to any of the components of the Study Product.
• • Has received treatment involving experimental drugs in the past 90 days and experimental supplements in the past 30 days at the discretion of the investigator.
• • Any Participant who is an employee of the study site or an Atlantia Clinical Trials employee or their immediate family member or a member of their household.
• • Individuals who, in the opinion of the investigator, are considered to be poor attendees or unlikely for any reason to be able to comply with the study.