The Impact of a Powdered Meal Replacement on Metabolism and Gut Microbiota

Plain-language summary

This study investigates the effect of a powdered meal replacement made from soy protein, honey, and yogurt on metabolism and gut microbiota. It was designed for participants aged 18-50 with a body mass index between 25 and 37. The study was conducted as a trial without an assigned phase and has been completed.

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase

Not Applicable

Status

Completed

Sponsor

University of Alberta

Intervention

Soy protein, honey and yogurt.

Start date

4/1/2019

Estimated completion

12/8/2023

Countries

Canada

Related genes

Locations

• Edmonton, Canada

Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.

Inclusion Criteria:

* Non-smoker;
* Female/Male;
* Aged 18 to 50 years;
* Body mass index (BMI) between 25 and 37 kg/m²;
* Weight stable (\< ± 5 kg over past 6 months);
* Fat mass ≥20% for men and ≥25% for women;
* Maintaining current levels of physical activity throughout the study.
* Female participants must verify use of acceptable, effective birth control methods (total abstinence, hormonal birth control \[oral, injectable, transdermal, intravaginal\], intrauterine devices, confirmed successful vasectomy or partner, or condoms).

Exclusion Criteria:

* Diagnosis of chronic diseases or acute infections;
* Taking any medication that may alter inflammation, energy metabolism, body weight and composition, gut microbiota and hormone levels; investigators should always be informed if there are any changes in medications or Natural health product use;
* Taking pre- and probiotics (e.g. supplements);
* Use of antibiotics in the past two months;
* Use of thyroid replacement therapy;
* Use of nutritional supplements in the past four weeks (multivitamin and vitamin D3 are permitted to be used during the course of the study);
* Allergy to any ingredient (including non-medicinal ingredients) in investigational product;
* Lactose, gluten and/or soy allergic/intolerant;
* Follow a vegetarian, vegan or any restrictive dietary pattern;
* Pregnant or lactating;
* Perform over three hours of vigorous physical activity per week;
* A nuclear medicine scan or injection of an X-ray dye in the past week;
* A barium test/exam in the last two weeks;
* Suffer from claustrophobia;
* Inability to comprehend and complete the required questionnaires.