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

Camila L P Oliveira, Normand G Boulé, Arya M Sharma, Sarah Elliott, Mario Siervo, Sunita Ghosh, Aloys Berg, Carla M Prado, Camila L P Oliveira, Normand G Boulé, Arya M Sharma, Sarah Elliott, Mario Siervo, Sunita Ghosh, Aloys Berg, Carla M Prado

Abstract

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).

Keywords: Protein, Total diet replacement, Energy metabolism, Metabolic biomarkers, Appetite, Adults.

Conflict of interest statement

The authors declare that they have no competing interests.

Figures

Fig. 1
Fig. 1
Experimental protocol. Abbreviations: CON control diet, HP-TDR high-protein total diet replacement, RMR resting metabolic rate, WBCU whole-body calorimetry unit
Fig. 2
Fig. 2
Schedule of enrollment, interventions and assessments (SPIRIT figure). Abbreviation: CON control diet, HP-TDR high-protein total diet replacement, RMR resting metabolic rate

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