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

Status: Recruiting
Location: See location...
Intervention Type: Dietary supplement
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 50
Maximum Age: 65
Healthy Volunteers: t
View:

• 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.

Locations
Other Locations
Ireland
Atlantia Food Clinical Trials
RECRUITING
Cork
Contact Information
Primary
Andrea Doolan
adoolan@atlantiatrials.com
(0)87 659 7199
Backup
Emily Goodbody
egoodbody@atlantiatrials.com
(0)86 218 8787
Time Frame
Start Date: 2024-01-29
Estimated Completion Date: 2025-10
Participants
Target number of participants: 120
Treatments
Experimental: Freeze-dried Blueberries
Participants will be provided with an 8-week supply of study product (freeze-dried blueberry) to be consumed daily.
Placebo_comparator: Maltodextrin, Glucose, Fructose and Sucrose Placebo
Participants will be provided with an 8-week supply of placebo product (maltodextrin, glucose 31%, fructose 30%, sucrose 0%; produced as a purple powder, with blueberry aromatics generated from natural (non-anthocyanin) and artificial colour and flavourings) to be consumed daily.
Related Therapeutic Areas
Sponsors
Collaborators: U.S. Highbush Blueberry Council
Leads: University College Cork

This content was sourced from clinicaltrials.gov