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

The Impact of a Powdered Meal Replacement on Metabolism and Gut Microbiota: a 12-week Study in Individuals With Excessive Body Weight

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.

Study Overview

• Status: Completed
• Conditions: Dietary Modification
• Intervention / Treatment: Dietary supplement: Soy protein, honey and yogurt.

Detailed Description

Overweight and obesity increase the risk of developing several diseases having a negative effect on people's health. The prevalence of these conditions is increasing worldwide, but successful treatments are lacking. As excess body weight is a result of an imbalance between calories in and calories out, dietary intake plays an important role in maintaining a healthy body weight and overall health status. Meal replacements are nutritionally complete formula foods used to substitute a meal. They can be a drink, bar, or soup. These products have been gaining popularity because they can help individuals lose weight. In addition, depending on its ingredients, meal replacements may affect our health. For this reason, meal replacements have been studied for health benefits. However, how meal replacements affect the microbes living in our gut, inflammation, and our genes is not known. Well-designed studies using state-of-the-art equipment can help elucidate the mechanisms by meal replacements act in individuals with overweight or obesity.

The overall purpose of this research is to 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, soy metabolomics, gene expression, and genetic polymorphisms 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. 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 (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 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%).

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 [hs-CRP], IL-8, IL-10 and tumor necrosis factor-α [TNF-α]);
• Metabolic blood markers [glucose, insulin, lipid panel (i.e. total cholesterol, LDL, HDL, and triglycerides), peptide tyrosine-tyrosine (PYY), glucagon-like peptide-1 (GLP-1), ghrelin, adiponectin, leptin, free glycerol, free fatty acids, and thyroid stimulating hormone (TSH)];
• 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 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. Dietary intake will be assessed by a 3-day dietary record (2 week days and 1 weekend day) at baseline, at mid-point and end of the study. Participants will also be asked to complete a 1-day dietary record on one weekday, each week of the study. The purpose of this regular assessment is to avoid daily fluctuations in eating patterns, also ensuring a personalized feedback for those experiencing weight fluctuations. Both of these assessments (i.e. 1-day and 3-day dietary records) will be conducted using the online Automated Self -Administered 24-hour Recall (ASA24) Canada. The ASA24 is a validated web-based program that uses the validated U.S. Department of Agriculture's Automated Multiple-Pass Method, and is modified to support the Canadian food supply.

Participants will receive a digital scale and will be asked to weight themselves daily. Participants from the PMR group will also be asked to rate their appetite sensations on a 100-mm VAS paper sheet. Appetite sensation should be completed in the morning (after waking up and while fasting) and 30 minutes after consuming the supplement snacks in order to assess hunger, satiety, fullness, and prospective food consumption.

• Study Type: Interventional
• Enrollment (Actual): 88
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Edmonton, Alberta, Canada
      • Human Nutrition Research Unit

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control Group; 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).
Experimental: Powdered Meal Replacement Group; 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.; 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%).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gut microbiota diversity and composition.	Changes in gut microbiome diversity and composition (specifically taxa that have been associated with health benefits, obesity and weight loss) 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).

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
High-sensitivity C-reactive protein.	Changes in blood high-sensitivity C-reactive protein 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).
Interleukin 8.	Changes in interleukin 8 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).
Interleukin 10.	Changes in interleukin 10 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).
Tumor necrosis factor-α.	Changes in tumor necrosis factor-α 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).
Adiponectin.	Changes in adiponectin 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).
Blood glucose.	Changes in blood glucose 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).
Insulin.	Changes in insulin 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).
Lipid panel.	Changes in lipid panel (i.e. total cholesterol, LDL, HDL and triglycerides) 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).
Peptide tyrosine-tyrosine.	Changes in peptide tyrosine-tyrosine 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).
Glucagon-like peptide 1.	Changes in glucagon-like peptide-1 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).
Ghrelin.	Changes in ghrelin 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).
Leptin.	Changes in leptin 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).
Free glycerol.	Changes free glycerol 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).
Free fatty acids.	Changes in free fatty acids 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).
Thyroid stimulating hormone.	Changes in thyroid stimulating hormone 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).
Resting energy expenditure.	Changes in resting energy expenditure will be assessed at baseline, middle and end of the 12-week dietary intervention period using a whole body calorimetry unit.	At baseline (week 1), middle (week 6) and end (week 12) of the intervention period (12 weeks).
Body composition.	Changes in fat mass, lean soft tissue and bone mineral content will be assessed at baseline, middle and end of the 12-week dietary intervention period using dual-energy X-ray absorptiometry.	At baseline (week 1), middle (week 6) and end (week 12) of the intervention period (12 weeks).
Appetite sensations.	Changes in hunger, satiety, fullness, and prospective food consumption will be assessed weekly using a 100 mm visual analogue scale.	Once per week during the intervention period (12 weeks).
Soy polyphenols' metabolomics.	Soy polyphenols' metabolomics will be assessed on participants assigned to the 12-week dietary intervention periodPowdered Meal Replacement group at baseline, middle and end of the 12-week dietary intervention period using blood and urine samples.	At baseline (week 1), middle (week 6) and end (week 12) of the intervention period (12 weeks).
Gene expression	Changes in gene expression will be assessed at baseline and at the end of the 12-week dietary intervention period	At baseline (week 1) and end (week 12) of the intervention period (12 weeks).
Genetic polymorphisms	Genetic polymorphisms will be identified at baseline	At baseline (week 1)

Collaborators and Investigators

• Sponsor: University of Alberta
• Collaborators: Almased Wellness GmbH
• Investigators: Principal Investigator: Carla M Prado, PhD, University of Alberta; Principal Investigator: Arya Sharma, PhD, University of Alberta; Principal Investigator: Jens Walter, PhD, University of Alberta

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2019
• Primary Completion (Actual): December 8, 2023
• Study Completion (Actual): December 8, 2023

Study Registration Dates

• First Submitted: July 27, 2017
• First Submitted That Met QC Criteria: July 31, 2017
• First Posted (Actual): August 1, 2017

Study Record Updates

• Last Update Posted (Estimated): December 14, 2023
• Last Update Submitted That Met QC Criteria: December 12, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Inflammation; Body composition; Gut microbiota; Energy metabolism; Powdered meal replacement
• Other Study ID Numbers: Pro00070712

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No