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

Summary

The goal of this clinical trial is to evaluate the effect of freeze-dried blueberry powder on the gut microbiome in overweight and obese adults. The main question\[s\] it aims to answer are:

* Does the supplementation of freeze-dried blueberry powder reduce the risk of obesity or lower the weight of people with a high BMI?
* Does freeze-dried blueberry powder alter the gut microbiome function? Participants will;
* Mix one sachet of Study Product (freeze-dried blueberry powder/placebo) into breakfast/dessert/yoghurt daily for 56 days during the intervention phase.
* Partake in 4 site visits over the 14-week period, including an initial screening visit and a follow-up visit after the intervention phase.

Researchers will compare the effect of freeze-dried blueberry powder with a placebo in a population comprising overweight and obese adults to see if the gut microbiome is altered and if there is a change in body composition.

Conditions

• Obesity
• Overweight and Obesity

Interventions

DIETARY_SUPPLEMENT

Freeze-dried blueberries

* Participants will be supplied with an 8-week supply of Study Product and instructions of dosing. * Participants will be instructed to mix one sachet of the Study Product either to breakfast, or dessert, or mixed with yoghurt daily for the next 56 days, starting on the same day, Day 1. * Additional product will be supplied in case of delay of study visit or loss of Study Product. * Participants will be provided with a stool collection kit and instructions for collecting and storing. Participants will collect stool samples at home, within 48 hours prior to their visit but preferably the morning, of their scheduled visit and bring it to the clinic. * Participants will be provided with a urine collection kit and instructions for collecting and storing.

DIETARY_SUPPLEMENT

Placebo

* Participants will be supplied with an 8-week supply of Placebo Product and instructions of dosing. * Participants will be instructed to mix one sachet of the Placebo Product either to breakfast, or dessert, or mixed with yoghurt daily for the next 56 days, starting on the same day, Day 1. * Additional product will be supplied in case of delay of study visit or loss of Placebo Product. * Participants will be provided with a stool collection kit and instructions for collecting and storing. Participants will collect stool samples at home, within 48 hours prior to their visit but preferably the morning, of their scheduled visit and bring it to the clinic. * Participants will be provided with a urine collection kit and instructions for collecting and storing.

Sponsors & Collaborators

• U.S. Highbush Blueberry Council

  collaborator OTHER

• University College Cork

  lead OTHER

Principal Investigators

• Paul W. O'Toole, Prof. · University College Cork

• Timothy Dinan, Prof. · Atlantia Clinical Trials

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

50 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2024-01-29

Primary Completion

2024-09-30

Completion

2025-10-31

Countries

• Ireland

Study Locations