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Clinical Trials/NCT02945410
NCT02945410CompletedNot Applicable

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

University of Nebraska Lincoln1 site in 1 country20 target enrollmentStarted: September 1, 2016Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
20
Locations
1
Primary Endpoint
Change in Circulating IGF-1

Study Overview

Brief 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).

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover
Primary Purpose
Prevention
Masking
Single (Participant)

Eligibility Criteria

Ages
19 Years to 30 Years (Adult)
Sex
Male
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • •4 hours/week of purposeful aerobic exercise over the last 3 months
  • •Body mass index: 19-25 kg/m2
  • •< 15% body fat

Exclusion Criteria

  • •Cardiovascular disease risk factors that would result in greater than low risk
  • •Type I, type II diabetes, or history of high fasting glucose;
  • •History of high blood pressure and/or use of medication for hypertension;
  • •History of Dyslipidemia, or on lipid-lowering medication;
  • •Underlying health condition and/or use of medication that could interfere with any of our study outcomes.
  • •History or current diagnosis of a clinical eating disorder
  • •Failure to adhere to study protocol

Arms & Interventions

Caloric Restriction and High Protein

Experimental

Participants will be calorie restricted to 30 kcal/kg FFM/day and consume 1.7 g protein/kg BW/day.

Intervention: Caloric Restriction (Other)

Caloric Restriction and High Protein

Experimental

Participants will be calorie restricted to 30 kcal/kg FFM/day and consume 1.7 g protein/kg BW/day.

Intervention: Protein (Other)

Caloric Restriction and High Protein

Experimental

Participants will be calorie restricted to 30 kcal/kg FFM/day and consume 1.7 g protein/kg BW/day.

Intervention: Exercise (Other)

Caloric Restriction and Normal Protein

Active Comparator

Participants will be calorie restricted to 30 kcal/kg FFM/day and consume 0.8 g protein/kg BW/day.

Intervention: Caloric Restriction (Other)

Caloric Restriction and Normal Protein

Active Comparator

Participants will be calorie restricted to 30 kcal/kg FFM/day and consume 0.8 g protein/kg BW/day.

Intervention: Exercise (Other)

Energy Balance

Placebo Comparator

Participants will be in energy balance and consume 1.7 g protein/kg BW/day.

Intervention: Protein (Other)

Energy Balance

Placebo Comparator

Participants will be in energy balance and consume 1.7 g protein/kg BW/day.

Intervention: Exercise (Other)

Caloric Restriction and Normal Protein

Active Comparator

Participants will be calorie restricted to 30 kcal/kg FFM/day and consume 0.8 g protein/kg BW/day.

Intervention: Maltodextrin (Other)

Energy Balance

Placebo Comparator

Participants will be in energy balance and consume 1.7 g protein/kg BW/day.

Intervention: Maltodextrin (Other)

Energy Balance

Placebo Comparator

Participants will be in energy balance and consume 1.7 g protein/kg BW/day.

Intervention: Calcium and Vitamin D (Dietary Supplement)

Caloric Restriction and Normal Protein

Active Comparator

Participants will be calorie restricted to 30 kcal/kg FFM/day and consume 0.8 g protein/kg BW/day.

Intervention: Calcium and Vitamin D (Dietary Supplement)

Caloric Restriction and High Protein

Experimental

Participants will be calorie restricted to 30 kcal/kg FFM/day and consume 1.7 g protein/kg BW/day.

Intervention: Maltodextrin (Other)

Caloric Restriction and High Protein

Experimental

Participants will be calorie restricted to 30 kcal/kg FFM/day and consume 1.7 g protein/kg BW/day.

Intervention: Calcium and Vitamin D (Dietary Supplement)

Outcomes

Primary Outcomes

Change in Circulating IGF-1

Time Frame: Baseline and day 6

Change in Resting Metabolic Rate

Time Frame: Baseline and day 6

Change in Marker of Bone Formation (P1NP)

Time Frame: Baseline and day 6

Change in Marker of Bone Resorption (CTx)

Time Frame: Baseline and day 6

Secondary Outcomes

  • Change in Perceived Hunger(Baseline and day 6)
  • Change in Body Weight(Baseline and day 6)
  • Change in Body Fat Percentage(Baseline and day 6)
  • Change in Aerobic Fitness (VO2peak)(Baseline and day 6)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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