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

NCT03235804 | Completed DMC

• 1 other identifier: Pro00070712
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Powdered meal replacement; Inflammation; Gut microbiota; Energy metabolism; Body composition

Outcome Measures

Primary Outcomes (1)

• Interleukin-6.

  Changes in blood interleukin-6 will be assessed at baseline, middle and end of the 12-week dietary intervention period.

  At baseline (week 1), middle (week 6) and end (week 12) of the intervention period (12 weeks).

Secondary Outcomes (1)

• Gut microbiota diversity and composition.

  At baseline (week 1), middle (week 6) and end (week 12) of the intervention period (12 weeks).

Other Outcomes (21)

• High-sensitivity C-reactive protein.

  At baseline (week 1), middle (week 6) and end (week 12) of the intervention period (12 weeks).

• Interleukin 8.

  At baseline (week 1), middle (week 6) and end (week 12) of the intervention period (12 weeks).

• Interleukin 10.

  At baseline (week 1), middle (week 6) and end (week 12) of the intervention period (12 weeks).

Study Arms (2)

Control Group

NO INTERVENTION

Those assigned to the Control group will be asked to maintain their usual dietary intake over 12 weeks. Participants' 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

EXPERIMENTAL

Those assigned to the Powdered Meal Replacement group 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%).

Dietary Supplement: Soy protein, honey and yogurt.

Interventions

Soy protein, honey and yogurt. DIETARY_SUPPLEMENT

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%).

Powdered Meal Replacement Group

Eligibility Criteria

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

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Alberta: lead
• Almased Wellness GmbH: collaborator

Study Sites (1)

Human Nutrition Research Unit

Edmonton, Alberta, Canada

Location

Related Publications (1)

• Montenegro J, L P Oliveira C, Armet AM, Berg A, Sharma AM, Mereu L, Cominetti C, Ghosh S, Richard C, Nguyen NK, Cani PD, Walter J, Prado CM. Impact of a Powdered Meal Replacement on Metabolism and Gut Microbiota (PREMIUM) in individuals with excessive body weight: a study protocol for a randomised controlled trial. BMJ Open. 2023 Sep 13;13(9):e070027. doi: 10.1136/bmjopen-2022-070027.

  PMID: 37709337 DERIVED

MeSH Terms

Conditions

Inflammation

Interventions

Soybean Proteins; Honey; Yogurt

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Plant Proteins; Proteins; Amino Acids, Peptides, and Proteins; Plant Proteins, Dietary; Dietary Proteins; Food; Diet, Food, and Nutrition; Physiological Phenomena; Soy Foods; Vegetable Products; Vegetables; Food and Beverages; Cultured Milk Products; Milk; Beverages; Fermented Foods; Dairy Products

Study Officials

• Jens Walter, PhD

  University of Alberta

  PRINCIPAL INVESTIGATOR

• Carla M Prado, PhD

  University of Alberta

  PRINCIPAL INVESTIGATOR

• Arya Sharma, PhD

  University of Alberta

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 27, 2017
• First Posted: August 1, 2017
• Study Start: April 1, 2019
• Primary Completion: December 8, 2023
• Study Completion: December 8, 2023
• Last Updated: December 14, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)