The Impact of a High Protein Diet on Substrate Oxidation and Energy Metabolism

NCT02811276 | Completed

• 1 other identifier: Pro00066006
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

In the 19th century, researchers found out that the differences in the energy content of macronutrients (protein, carbohydrate and fat) can elicit different responses in the amount of calories individuals burn per day. It was demonstrated that protein has a metabolic advantage when compared to the other macronutrients (carbohydrate and fat). Since these findings, researchers all over the world started to study how diets differing in macronutrient distribution could result in different responses to energy metabolism. Diets with high amounts of protein (i.e. meats, eggs, dairy products, and grains) are becoming more popular, and studies have shown that when people eat high quantities of protein they lose weight and fat mass, maintain the weight loss, and burn more calories per day. The investigators hypothesize that giving high amounts of protein to healthy women will increase the amount of calories and fat they burn per day, increase their satiety, and improve health markers when compared to a normal diet. The increased protein level will be achieved using a nutrition supplement consisted of soy protein, yogurt and honey. To test this, the investigators plan to divide the participants in two groups: one will eat a normal diet and the other a diet with high amounts of protein during one and a half day. After one month they will change groups and eat the other diet for the same period of time. During this period consuming the diets (1.5 days), participants will stay inside a whole body calorimetry suite, which is similar to a hotel bedroom and is able to inform in the most precise way the amount of calories participants will burn and if they are burning more fat. Additionally, before and after each meal participants will have to answer a questionnaire about their appetite sensations and blood will also be collected to analyze health markers.

Conditions

Dietary Modification

Keywords

High-protein diet; Energy metabolism; Substrate oxidation

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 Group

NO INTERVENTION

Those assigned to the Control Group will receive a eucaloric diet (a diet designed to meet the person's energy needs and maintain body weight) composed of 55% of carbohydrate, 15% of protein, and 30% of lipid.

High-Protein Diet Group

EXPERIMENTAL

Those assigned to the High-Protein Diet Group will receive a eucaloric diet composed of 35% of carbohydrate, 40% of protein, and 25% of lipid constructed around a soy protein-based meal replacement (Almased®).

Other: Diet

Interventions

Diet OTHER

The High-Protein Diet Group will receive a eucaloric diet composed of 35% of carbohydrate, 40% of protein, and 25% of lipid constructed around a soy protein-based meal replacement (Almased®) for one and a half day. Participants will consume 1 gram ± 0.1 of Almased® per kg of body weight mixed with linseed oil and skim milk in their breakfast, lunch and dinner. Two snacks (afternoon and evening) composed of 1 gram ± 0.1 of Almased® per kg of body weight mixed with vegetable juice and linseed oil will also be provided.

High-Protein Diet Group

Eligibility Criteria

• Age: 18 Years - 34 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy;
• Non-smoker;
• Female;
• Aged 18 to 34.9 years;
• Body mass index (BMI) between 18.5 and 24.9 kg/m² (preferably between 20 and 24.9 kg/m²);
• Regular menstrual cycle (lasting between 25 and 35 days).

You may not qualify if:

• Have previously been diagnosed with any kind of disease;
• Are taking any medications which may alter energy metabolism or body composition;
• Are lactose, gluten and/or soy allergic/intolerant;
• Follow a vegetarian, vegan or restrictive dietary pattern;
• Are pregnant or lactating;
• Have used nutritional supplements in the past two months;
• Perform over an hour per day of leisure time physical activity or more than seven hours per week of strenuous activity;
• 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;
• 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

Intervention Hierarchy (Ancestors)

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

Study Officials

• Carla MM Prado, PhD

  University of Alberta

  PRINCIPAL INVESTIGATOR

• Arya Sharma, PhD

  Unviersity 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; and Director of the Human Nutrition Research Unit

Study Record Dates

• First Submitted: June 16, 2016
• First Posted: June 23, 2016
• Study Start: October 1, 2016
• Primary Completion: March 1, 2018
• Study Completion: March 1, 2018
• Last Updated: August 28, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)