Clinical Trials Directory

Trials / Completed

CompletedNCT02945410

Effect of Caloric Restriction and Protein Intake on Metabolism and Anabolic Sensitivity

Can Increased Dietary Protein Prevent the Suppression of Metabolism and Maintain Anabolic Sensitivity of Bone and Skeletal Muscle During Caloric Restriction?

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
20 (actual)
Sponsor
University of Nebraska Lincoln · Academic / Other
Sex
Male
Age
19 Years – 30 Years
Healthy volunteers
Accepted

Summary

The purpose of this study is to determine if an increased protein intake can attenuate the suppression of metabolic and anabolic hormones during caloric restriction

Detailed description

1. Preliminary testing Prior to the study start, participants will be weighed and body composition will be determined using calipermetry (7 sites) and bioelectrical impedance. Peak oxygen uptake (VO2peak) will be assessed using an incremental exercise test on a bicycle ergometer. 2. Randomization Participants will proceed through each of the following conditions lasting 5 days: CR-LP: Participants will be restricted to 30 kcal/kg FFM/day and protein intake will be low (0.8 g/kg BW/day). CR-HP: Participants will be restricted to 30 kcal/kg FFM/day and protein intake will be high (1.7 g/kg BW/day). CON: Participants will be in energy balance and consume 1.7 g protein/kg BW/day. 3. Diet Prescription Dietary energy intake will be controlled using clinical products and maltodextrin to meet target energy intakes. Participants will received calcium and Vitamin D supplementation throughout the study. 4. Exercise Prescription During all conditions, participants will conduct daily supervised exercise on a bicycle ergometer at an exercise intensity of 60% VO2peak. Exercise duration will be adjusted individually such that exercise energy expenditure will amount to 15 kcal/kg FFM/day. Additional exercise and intense physical activity will be prohibited. 5. Assessments The following assessments will be conducted prior to the start of each condition as well as upon completion of each condition: body weight and composition (impedance), fasting blood draw for assessment of metabolic and anabolic hormones, resting metabolic rate, aerobic fitness (VO2peak), and questionnaires. 6. Washout Once a participant has completed a study condition, participant will be allowed a washout of at least 14 days to allow protein balance to return to baseline (Hoffer \& Forse, 1990). During this time, participants will resume their regular diet and physical activity.

Conditions

Interventions

TypeNameDescription
OTHERCaloric RestrictionParticipants will consume 30 kcal/kg FFM/day.
OTHERProteinParticipants will consume 1.7 g protein/kg BW/day.
OTHERExerciseParticipants will conduct aerobic exercise designed to expend 15 kcal/kg FFM/day
DIETARY_SUPPLEMENTCalcium and Vitamin DParticipants will be provided calcium and vitamin D supplement in order to maintain calcium and Vitamin D intake constant across all study arms
OTHERMaltodextrinParticipants will be provided with maltodextrin to supplement the liquid diet in order to meet caloric needs within each study arm

Timeline

Start date
2016-09-01
Primary completion
2019-02-01
Completion
2019-02-01
First posted
2016-10-26
Last updated
2019-12-19
Results posted
2019-12-19

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT02945410. Inclusion in this directory is not an endorsement.