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

Summary

This study will investigate the impact of a 12-week powdered meal replacement on inflammatory, metabolic, and hormonal markers of obesity-associated conditions and to correlate this response to compositional shifts within the gut microbiota. Moreover, resting energy expenditure, body composition, appetite sensations and soy metabolomics will be explored.

This study will be a randomized, parallel group, clinical trial of a 12-week nutritional intervention. A sample size of n=88 participants will be randomly allocated into one of the following groups:

* Control group (CON): Participants will be asked to maintain their usual dietary intake over 12 weeks. Their usual dietary intake is expected to reflect the North American dietary pattern (i.e. \~15% of total energy intake coming from protein, \~50% from carbohydrate and \~35% from fat).
* Powdered Meal Replacement group (PMR): Participants will be asked to maintain their usual dietary intake and consume a powdered meal replacement composed of soy protein, honey and yogurt twice daily (in two snacks) over 12 weeks. The addition of the meal replacement to a North American Dietary Pattern (described on the CON group diet) will result in a diet composed of, approximately, 22% of protein, 48% of carbohydrate and 30% of fat of total energy intake.

The following variables will be analyzed:

* Interleukin (IL)-6.
* Gut microbiota diversity and composition, specifically taxa that have been associated with health benefits, obesity, and weight loss.
* Systemic inflammatory biomarkers (high-sensitivity C-reactive protein, IL-8, IL-10 and tumor necrosis factor-α);
* Metabolic blood markers (glucose, insulin, lipid panel, peptide tyrosine-tyrosine, glucagon-like peptide-1, ghrelin, adiponectin, leptin, free glycerol, free fatty acids, and thyroid stimulating hormone)
* Resting energy expenditure;
* Body composition;
* Appetite sensations (hunger, satiety, fullness, and prospective food consumption);
* Soy polyphenols' metabolomics.
* Gene expression and genetic polymorphisms. At baseline and after 6 and 12 weeks, individuals will attend our Human Nutrition Research Unit where all assessments will take place. In order to assess participants' adherence and follow-up, dietary intake, body weight and appetite sensations (only for participants assigned to the PMR group) will be assessed weekly during the 12-week intervention period. Additionally, participants will be contacted by phone weekly and reminded to maintain their journal/log.

Conditions

• Dietary Modification

Interventions

DIETARY_SUPPLEMENT

Soy protein, honey and yogurt.

Participants will be asked to maintain their usual dietary intake and consume a powdered meal replacement composed of soy protein, honey and yogurt twice daily (in two snacks) over 12 weeks. The addition of the nutritional supplement to a North American Dietary Pattern (described on the CON group diet) will result in a diet composed of, approximately, 22% of protein, 48% of carbohydrate and 30% of fat of total energy intake. The amount of protein is considered higher than the North American dietary pattern (i.e. 15%); however, still within the Acceptable Macronutrient Distribution Range (AMDR) recommended by the Dietary Guidelines for Americans (10-35%).

Sponsors & Collaborators

• Almased Wellness GmbH

  collaborator INDUSTRY

• University of Alberta

  lead OTHER

Principal Investigators

• Jens Walter, PhD · University of Alberta

• Carla M Prado, PhD · University of Alberta

• Arya Sharma, PhD · University of Alberta

Study Design

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

50 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2019-04-01

Primary Completion

2023-12-08

Completion

2023-12-08

Countries

• Canada

Study Locations