Evaluating the effects of blueberry powder on gut health in overweight adults

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.