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

NCT06256653 | Recruiting

• 1 other identifier: AFCRO-175
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Gut Microbiome; Obesity; Overweight; Gut Permeability

Outcome Measures

Primary Outcomes (2)

• Effect of freeze-dried blueberry powder on the gut microbiome.

  To evaluate the effect of freeze-dried blueberry powder compared to placebo, in a population comprising of overweight and obese adults on: \- Alteration of gut microbiome function and gene count Change in gut microbiome function and gene count, as measured by shotgun metagenomics from baseline (Week 0) to end of intervention (Week 8).

  8 weeks

• Effect of freeze-dried blueberry powder on the gut permeability

  To evaluate the effect of freeze-dried blueberry powder compared to placebo, in a population comprising of overweight and obese adults on: \- Gut permeability Change in gut permeability, as measured from lactulose/mannitol ratio from baseline (Week 0) to end of intervention (Week 8).

  8 weeks

Secondary Outcomes (6)

• Effect of freeze-dried blueberry powder on lipid profile in a population of overweight and obese adults

  8 weeks

• Effect of freeze-dried blueberry powder on body composition in a population of overweight and obese adults

  8 weeks

• Effect of freeze-dried blueberry powder on serum metabolites in a population of overweight and obese adults

  8 weeks

• Effect of freeze-dried blueberry powder on urine and faecal metabolites in a population of overweight and obese adults

  8 weeks

• Effect of freeze-dried blueberry powder on faecal bile acid metabolites in a population of overweight and obese adults

  8 weeks

Study Arms (2)

Freeze-dried Blueberries

EXPERIMENTAL

Participants will be provided with an 8-week supply of study product (freeze-dried blueberry) to be consumed daily.

Dietary Supplement: Freeze-dried blueberries

Maltodextrin, Glucose, Fructose and Sucrose Placebo

PLACEBO COMPARATOR

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.

Dietary Supplement: Placebo

Interventions

Freeze-dried blueberries DIETARY_SUPPLEMENT

* 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.

Freeze-dried Blueberries

Placebo DIETARY_SUPPLEMENT

* 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.

Maltodextrin, Glucose, Fructose and Sucrose Placebo

Eligibility Criteria

• Age: 50 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University College Cork: lead
• U.S. Highbush Blueberry Council: collaborator

Study Sites (1)

Atlantia Food Clinical Trials

Cork, Ireland

RECRUITING

MeSH Terms

Conditions

Obesity; Overweight

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Paul W. O'Toole, Prof.

  University College Cork

  STUDY DIRECTOR

• Timothy Dinan, Prof.

  Atlantia Clinical Trials

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Andrea Doolan

CONTACT

(0)87 659 7199; adoolan@atlantiatrials.com

Emily Goodbody

CONTACT

(0)86 218 8787; egoodbody@atlantiatrials.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Blinding of both study team and Participants will be ensured by only providing access to the randomisation list to the science and quality team which is stored in the quality drive. The relationship between the randomisation number and the group assignment will be unknown to the Participants, clinical study team, and the Sponsor, i.e., the study will be double-blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomised, double-blinded, placebo-controlled, parallel study in overweight and obese adults.

Study Record Dates

• First Submitted: January 16, 2024
• First Posted: February 13, 2024
• Study Start: January 29, 2024
• Primary Completion: September 1, 2024
• Study Completion: October 1, 2025
• Last Updated: July 16, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

IE (1)