The Impact of a High-protein Diet on Energy Metabolism in Healthy Men

NCT03565510 | Completed

• 1 other identifier: Pro00083005
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to investigate the impact of a high-protein diet (achieved with the use of a nutritional supplement, Almased®) versus a diet of a typical North American macronutrient distribution on energy metabolism, metabolic blood markers and appetite sensations. This study will be a randomized, controlled, cross-over trial of an acute nutritional intervention. A total of 20 participants will be randomly assigned (1:1) to one of the following groups:

• Control group (CON).
• High protein diet group (HP). The diets given to participants in both groups will be eucaloric. While receiving the diets in the whole body calorimetry unit for 32 hours, participants' overall changes in energy metabolism, metabolic blood markers, and appetite sensations will be assessed.

Conditions

Dietary Modification

Keywords

High-protein diet; Energy metabolism

Outcome Measures

Primary Outcomes (1)

• Difference in fat balance assessed by indirect calorimetry during 32 hours of a high-protein (HP) total diet replacement compared to 32hours of a control (CON) diet.

  To measure the differences in fat balance during 32 hours of a high-protein (HP) total diet replacement compared to 32hours of a control (CON) diet.

  During a 32-hour period while receiving a HP total diet replacement or a CON diet.

Secondary Outcomes (1)

• Difference in 24-hour energy expenditure assessed by indirect calorimetry during 32 hours of a high-protein (HP) total diet replacement compared to 32hours of a control (CON) diet.

  During a 32-hour period while receiving a HP total diet replacement or a CON diet.

Other Outcomes (13)

• Changes in appetite sensations assessed by a 100 mm visual analogue scale questionnaire.

  During a 32-hour period while receiving a HP total diet replacement or a CON diet.

• Changes in blood glucose levels.

  During a 32-hour period while receiving a HP total diet replacement or a CON diet.

• Changes in blood insulin levels.

  During a 32-hour period while receiving a HP total diet replacement or a CON diet.

Study Arms (2)

Control

NO INTERVENTION

Those assigned to the Control group will receive a diet composed of 55% of carbohydrate, 15% of protein, and 30% of lipid (similar to the North American dietary pattern).

High-Protein Diet

EXPERIMENTAL

Those assigned to the High-Protein Diet group will receive a diet composed of 35% of carbohydrate, 40% of protein, and 25% of lipid constructed around a soy protein-based total diet replacement.

Dietary Supplement: High-Protein Diet

Interventions

High-Protein Diet DIETARY_SUPPLEMENT

The high-protein diet is composed of 35% of carbohydrate, 40% of protein, and 25% of lipid constructed around a soy protein-based meal replacement.

High-Protein Diet

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy;
• Non-smoker;
• Male;
• Aged 18 to 34.9 years;
• BMI between 18.5 and 24.9 kg/m² (preferably between 20 and 24.9 kg/m2);

You may not qualify if:

• Have previously been diagnosed with any chronic disease;
• Are taking any medications which may alter energy metabolism or body composition (exception: if taking antidepressants in a stable dose for \> two months);
• Are lactose, gluten and/or soy allergic/intolerant;
• Follow a vegetarian, vegan or restrictive dietary pattern;
• Have used nutritional supplements in the past two months (except micronutrients);
• Are performing or have performed over an hour per day of leisure time physical activity or more than seven hours per week of strenuous activity in the past three months;
• Have had a nuclear medicine scan or injection of an X-ray dye in the past week;
• Have had a barium test/exam in the last two weeks;
• Suffer from claustrophobia.

Sponsors & Collaborators

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

Study Sites (1)

University of Alberta

Edmonton, Alberta, T6G 2E1, Canada

Location

Related Publications (3)

• Oliveira CLP, Boule NG, Elliott SA, Sharma AM, Siervo M, Berg A, Ghosh S, Prado CM. A high-protein total diet replacement alters the regulation of food intake and energy homeostasis in healthy, normal-weight adults. Eur J Nutr. 2022 Jun;61(4):1849-1861. doi: 10.1007/s00394-021-02747-1. Epub 2021 Dec 20.

  PMID: 34928408 DERIVED

• Oliveira CLP, Boule NG, Sharma AM, Elliott SA, Siervo M, Ghosh S, Berg A, Prado CM. A high-protein total diet replacement increases energy expenditure and leads to negative fat balance in healthy, normal-weight adults. Am J Clin Nutr. 2021 Feb 2;113(2):476-487. doi: 10.1093/ajcn/nqaa283.

  PMID: 33247306 DERIVED

• Oliveira CLP, Boule NG, Sharma AM, Elliott S, Siervo M, Ghosh S, Berg A, Prado CM. Examining the effects of a high-protein total diet replacement on energy metabolism, metabolic blood markers, and appetite sensations in healthy adults: protocol for two complementary, randomized, controlled, crossover trials. Trials. 2019 Dec 27;20(1):787. doi: 10.1186/s13063-019-3950-y.

  PMID: 31881910 DERIVED

MeSH Terms

Interventions

Diet, High-Protein

Intervention Hierarchy (Ancestors)

Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Carla Prado, PhD

  University of Alberta

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor / CAIP Chair in Nutrition, Food and Health, CIHR New Investigator

Study Record Dates

• First Submitted: June 11, 2018
• First Posted: June 21, 2018
• Study Start: August 1, 2018
• Primary Completion: October 31, 2019
• Study Completion: October 31, 2019
• Last Updated: January 23, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)