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

December 1, 2019 updated by: University of Nebraska Lincoln

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Nebraska
      • Lincoln, Nebraska, United States, 68583
        • Sports and Exercise Nutrition Laboratory, Department of Nutrition and Health Sciences, Ruth Leverton Hall

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 30 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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
  • Smoking
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Caloric Restriction and High Protein
Participants will be calorie restricted to 30 kcal/kg FFM/day and consume 1.7 g protein/kg BW/day.
Other: Caloric Restriction
Participants will consume 30 kcal/kg FFM/day.
Other: Protein
Participants will consume 1.7 g protein/kg BW/day.
Other: Exercise
Participants will conduct aerobic exercise designed to expend 15 kcal/kg FFM/day
Dietary supplement: Calcium and Vitamin D
Participants will be provided calcium and vitamin D supplement in order to maintain calcium and Vitamin D intake constant across all study arms
Other: Maltodextrin
Participants will be provided with maltodextrin to supplement the liquid diet in order to meet caloric needs within each study arm
Active Comparator: Caloric Restriction and Normal Protein
Participants will be calorie restricted to 30 kcal/kg FFM/day and consume 0.8 g protein/kg BW/day.
Other: Caloric Restriction
Participants will consume 30 kcal/kg FFM/day.
Other: Exercise
Participants will conduct aerobic exercise designed to expend 15 kcal/kg FFM/day
Dietary supplement: Calcium and Vitamin D
Participants will be provided calcium and vitamin D supplement in order to maintain calcium and Vitamin D intake constant across all study arms
Other: Maltodextrin
Participants will be provided with maltodextrin to supplement the liquid diet in order to meet caloric needs within each study arm
Placebo Comparator: Energy Balance
Participants will be in energy balance and consume 1.7 g protein/kg BW/day.
Other: Protein
Participants will consume 1.7 g protein/kg BW/day.
Other: Exercise
Participants will conduct aerobic exercise designed to expend 15 kcal/kg FFM/day
Dietary supplement: Calcium and Vitamin D
Participants will be provided calcium and vitamin D supplement in order to maintain calcium and Vitamin D intake constant across all study arms
Other: Maltodextrin
Participants will be provided with maltodextrin to supplement the liquid diet in order to meet caloric needs within each study arm

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in Resting Metabolic Rate
Time Frame: Baseline and day 6
Baseline and day 6
Change in Circulating IGF-1
Time Frame: Baseline and day 6
Baseline and day 6
Change in Marker of Bone Formation (P1NP)
Time Frame: Baseline and day 6
Baseline and day 6
Change in Marker of Bone Resorption (CTx)
Time Frame: Baseline and day 6
Baseline and day 6

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Body Weight
Time Frame: Baseline and day 6
Baseline and day 6
Change in Body Fat Percentage
Time Frame: Baseline and day 6
Baseline and day 6
Change in Aerobic Fitness (VO2peak)
Time Frame: Baseline and day 6
Analyzed in L/min rather than mL/kg/min to remove influence of weight loss.
Baseline and day 6
Change in Perceived Hunger
Time Frame: Baseline and day 6
Perceived hunger will be assessed using 0-100 visual analog scales. In this case, 100 means maximum hunger while 0 means minimal hunger.
Baseline and day 6

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Nebraska Lincoln

Investigators

  • Principal Investigator: Karsten Koehler, PhD, University of Nebraska Lincoln

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2016

Primary Completion (Actual)

February 1, 2019

Study Completion (Actual)

February 1, 2019

Study Registration Dates

First Submitted

October 10, 2016

First Submitted That Met QC Criteria

October 24, 2016

First Posted (Estimate)

October 26, 2016

Study Record Updates

Last Update Posted (Actual)

December 19, 2019

Last Update Submitted That Met QC Criteria

December 1, 2019

Last Verified

December 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 15895

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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