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.
Study Goal
The researchers aimed to compare the effects of a high-protein total diet replacement versus a control diet on energy expenditure, macronutrient oxidation rates, metabolic blood markers, and appetite sensations in healthy adults.
Results Summary
The abstract does not provide specific results, as the study is described as ongoing or not yet completed.
Population
Healthy young adults (both sexes)
Effective Dosage
High-protein total diet replacement: 35% carbohydrate, 40% protein, 25% fat
Duration
32 hours
Interactions
None mentioned
| Intervention | Direction | Endpoint | Population | Dosage | Impact | Claim # |
|---|---|---|---|---|---|---|
high-protein total diet replacement | neutral | energy expenditure, macronutrient oxidation rates and balances, metabolic blood markers and appetite sensations | healthy adults | - | compared the impact | #1 |
high-protein total diet replacement | neutral | energy metabolism, metabolic blood markers and appetite sensations | healthy young adults (of both sexes) | - | examining the impact | #2 |
BACKGROUND: High-protein diets and total diet replacements are becoming increasingly popular for weight regulation; however, further research is needed to elucidate their impact on the physiology of body weight regulation. The aim of this inpatient metabolic balance study is to compare the impact of a high-protein total diet replacement versus a control diet (North American) on energy expenditure, macronutrient oxidation rates and balances, metabolic blood markers and appetite sensations in healthy adults. METHODS: Two randomized, controlled, cross-over clinical trials conducted separately in men and women will be conducted. In each trial, participants will be allocated to two isocaloric arms: a) Control diet: 55% carbohydrate, 15% protein, and 30% fat; b) High-protein total diet replacement: 35% of carbohydrate, 40% protein, and 25% fat. They will receive the prescribed diets for 32 h while inside the whole-body calorimetry unit. Diets will be designed to ensure participants are in energy balance. The following physiological changes will be compared between groups: energy expenditure, macronutrient oxidation rates and balances, metabolic blood markers, and appetite sensations. Body composition will be assessed at baseline using dual-energy X-ray absorptiometry. DISCUSSION: This will be the first inpatient metabolic balance study examining the impact of a high-protein total diet replacement on energy metabolism, metabolic blood markers and appetite sensations in healthy young adults (of both sexes) using a whole-body calorimetry unit. Results of this clinical trial can ultimately be used to develop strategies to optimize high-protein diet interventions and weight management. TRIAL REGISTRATION: ClinicalTrials.gov Identifiers: NCT02811276 (registered on 16 June 2016) and NCT03565510 (registered on 11 June 2018). PROTOCOL VERSION: NCT02811276: version 10 (2 March 2018); NCT03565510: version 3 (28 September 2018).