Evaluating the effects of blueberry powder on gut health in overweight adults
A Randomised, Double-blinded, Placebo- Controlled, Parallel Study, to Assess the Effect of a Whole Fruit Powder on Gut Microbiome Function on Overweight & Obese Adults
This study is testing if adding freeze-dried blueberry powder to meals can improve gut health and help with weight management in overweight adults.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 50 Years to 65 Years |
| Sex | All |
| Sponsor | University College Cork Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Cork) |
| Trial ID | NCT06256653 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to assess the impact of freeze-dried blueberry powder on the gut microbiome and weight management in overweight and obese adults. Participants will consume the blueberry powder daily for 56 days, mixed into their meals, while attending four site visits over a 14-week period for assessments. The study will compare the effects of the blueberry powder against a placebo to determine any changes in gut microbiome function and body composition. The research seeks to understand if this dietary intervention can help reduce obesity risk and improve gut health.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 50 to 65 with a BMI greater than 27 kg/m2 who follow a low-fiber diet.
Not a fit: Patients with metabolic diseases, gastrointestinal disorders, or those who are pregnant or breastfeeding may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a natural dietary intervention to help manage obesity and improve gut health in overweight individuals.
How similar studies have performed: Other studies have shown promising results with dietary interventions targeting the gut microbiome, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Cork
- Atlantia Food Clinical Trials — Cork, Ireland (Recruiting)
Study contacts
- Principal investigator: Timothy Dinan, Prof. — Atlantia Clinical Trials
- Study coordinator: Andrea Doolan
- Email: adoolan@atlantiatrials.com
- Phone: (0)87 659 7199
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.