Clinical trial NCT02811276: The Impact of a High Protein Diet on Substrate Oxidation and Energy Metabolism
Official title: A Randomized, Controlled, Cross-over Trial Investigating the Impact of a High Protein Diet on Substrate Oxidation and Energy Metabolism in Healthy Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dietary Modification
Keywords: High-protein diet
Energy metabolism
Substrate oxidation
Lead sponsor: University of Alberta
Sponsor class: OTHER
Collaborators: name: Almased Wellness GmbH
First posted: 2016-06-23
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 34
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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.

Detailed description: The aim of this study is to investigate the impact of a high protein diet (achieved through the use of a high protein supplement) versus standard diet on substrate oxidation and energy expenditure using a state-of-the-art live-in whole body calorimetry unit (WBCU).

This study will be an acute randomized, controlled, cross-over trial. Healthy women (n=24) will receive a run-in diet for three days and will then be randomly allocated into one of the following groups: 1) Control group receiving an eucaloric standard diet (55% of carbohydrate, 15% of protein, and 30% of lipid); 2) High-protein group: eucaloric high protein diet (35% of carbohydrate, 40% of protein, and 25% of fat) constructed around a soy protein-based meal replacement. The wash-out period will be of approximately one month. While receiving the diets in the WBCU for 32 hours, participants' overall change in energy metabolism including respiratory quotient will be assessed. Additional assessments include metabolic blood markers (glucose, insulin, lipid panel, peptide tyrosine-tyrosine, ghrelin, leptin, free glycerol, and free fatty acids), and appetite sensations (hunger and satiety). Body composition and energy requirements will be assessed at baseline using dual-energy X-ray absorptiometry and indirect calorimetry, respectively.

It is expected that the high-protein diet will increase lipid oxidation, and energy expenditure, with other favorable changes in the additional markers when compared to the control group.

Eligibility criteria: Inclusion Criteria:

* 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).

Exclusion Criteria:

* 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.

Primary outcomes:
measure: 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.
timeFrame: During a 32-hour period while receiving a HP total diet replacement or a CON diet.
Secondary outcomes:
measure: 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.
timeFrame: During a 32-hour period while receiving a HP total diet replacement or a CON diet.
Other outcomes:
measure: Changes in appetite sensations assessed by a 100 mm visual analogue scale questionnaire.
timeFrame: During a 32-hour period while receiving a HP total diet replacement or a CON diet.
measure: Changes in blood glucose levels.
timeFrame: During a 32-hour period while receiving a HP total diet replacement or a CON diet.
measure: Changes in blood insulin levels.
timeFrame: During a 32-hour period while receiving a HP total diet replacement or a CON diet.
measure: Changes in blood lipid panel levels.
timeFrame: During a 32-hour period while receiving a HP total diet replacement or a CON diet.
measure: Changes in blood peptide tyrosine-tyrosine levels.
timeFrame: During a 32-hour period while receiving a HP total diet replacement or a CON diet.
measure: Changes in blood glucagon-like peptide-1 levels.
timeFrame: During a 32-hour period while receiving a HP total diet replacement or a CON diet.
measure: Changes in blood ghrelin levels.
timeFrame: During a 32-hour period while receiving a HP total diet replacement or a CON diet.
measure: Changes in blood leptin levels.
timeFrame: During a 32-hour period while receiving a HP total diet replacement or a CON diet.
measure: Changes in blood free glycerol levels.
timeFrame: During a 32-hour period while receiving a HP total diet replacement or a CON diet.
measure: Changes in blood free fatty acids levels.
timeFrame: During a 32-hour period while receiving a HP total diet replacement or a CON diet.
measure: Difference in 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.
timeFrame: During a 32-hour period while receiving a HP total diet replacement or a CON diet.
measure: Difference in substrate oxidation assessed by indirect calorimetry during 32 hours of a high-protein (HP) total diet replacement compared to 32hours of a control (CON) diet.
timeFrame: During a 32-hour period while receiving a HP total diet replacement or a CON diet.
measure: Difference in substrate balance assessed by indirect calorimetry during 32 hours of a high-protein (HP) total diet replacement compared to 32hours of a control (CON) diet.
timeFrame: During a 32-hour period while receiving a HP total diet replacement or a CON diet.
Locations:
city: Edmonton
country: Canada
facility: University of Alberta
state: Alberta
Study officials:
affiliation: University of Alberta
name: Carla MM Prado, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Unviersity of Alberta
name: Arya Sharma, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.