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

Primary Purpose

Weight Loss, Starvation

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Caloric Restriction
Protein
Exercise
Calcium and Vitamin D
Maltodextrin
Sponsored by
University of Nebraska Lincoln
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Weight Loss

Eligibility Criteria

19 Years - 30 Years (Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

  • Sports and Exercise Nutrition Laboratory, Department of Nutrition and Health Sciences, Ruth Leverton Hall

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

Caloric Restriction and High Protein

Caloric Restriction and Normal Protein

Energy Balance

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

Change in Resting Metabolic Rate
Change in Circulating IGF-1
Change in Marker of Bone Formation (P1NP)
Change in Marker of Bone Resorption (CTx)

Secondary Outcome Measures

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

Full Information

First Posted
October 10, 2016
Last Updated
December 1, 2019
Sponsor
University of Nebraska Lincoln
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1. Study Identification

Unique Protocol Identification Number
NCT02945410
Brief Title
Effect of Caloric Restriction and Protein Intake on Metabolism and Anabolic Sensitivity
Official Title
Can Increased Dietary Protein Prevent the Suppression of Metabolism and Maintain Anabolic Sensitivity of Bone and Skeletal Muscle During Caloric Restriction?
Study Type
Interventional

2. Study Status

Record Verification Date
December 2019
Overall Recruitment Status
Completed
Study Start Date
September 2016 (undefined)
Primary Completion Date
February 2019 (Actual)
Study Completion Date
February 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Nebraska Lincoln

4. Oversight

Data Monitoring Committee
No

5. Study Description

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
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. 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. 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. 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. 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Weight Loss, Starvation

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Caloric Restriction and High Protein
Arm Type
Experimental
Arm Description
Participants will be calorie restricted to 30 kcal/kg FFM/day and consume 1.7 g protein/kg BW/day.
Arm Title
Caloric Restriction and Normal Protein
Arm Type
Active Comparator
Arm Description
Participants will be calorie restricted to 30 kcal/kg FFM/day and consume 0.8 g protein/kg BW/day.
Arm Title
Energy Balance
Arm Type
Placebo Comparator
Arm Description
Participants will be in energy balance and consume 1.7 g protein/kg BW/day.
Intervention Type
Other
Intervention Name(s)
Caloric Restriction
Intervention Description
Participants will consume 30 kcal/kg FFM/day.
Intervention Type
Other
Intervention Name(s)
Protein
Intervention Description
Participants will consume 1.7 g protein/kg BW/day.
Intervention Type
Other
Intervention Name(s)
Exercise
Intervention Description
Participants will conduct aerobic exercise designed to expend 15 kcal/kg FFM/day
Intervention Type
Dietary Supplement
Intervention Name(s)
Calcium and Vitamin D
Intervention Description
Participants will be provided calcium and vitamin D supplement in order to maintain calcium and Vitamin D intake constant across all study arms
Intervention Type
Other
Intervention Name(s)
Maltodextrin
Intervention Description
Participants will be provided with maltodextrin to supplement the liquid diet in order to meet caloric needs within each study arm
Primary Outcome Measure Information:
Title
Change in Resting Metabolic Rate
Time Frame
Baseline and day 6
Title
Change in Circulating IGF-1
Time Frame
Baseline and day 6
Title
Change in Marker of Bone Formation (P1NP)
Time Frame
Baseline and day 6
Title
Change in Marker of Bone Resorption (CTx)
Time Frame
Baseline and day 6
Secondary Outcome Measure Information:
Title
Change in Body Weight
Time Frame
Baseline and day 6
Title
Change in Body Fat Percentage
Time Frame
Baseline and day 6
Title
Change in Aerobic Fitness (VO2peak)
Description
Analyzed in L/min rather than mL/kg/min to remove influence of weight loss.
Time Frame
Baseline and day 6
Title
Change in Perceived Hunger
Description
Perceived hunger will be assessed using 0-100 visual analog scales. In this case, 100 means maximum hunger while 0 means minimal hunger.
Time Frame
Baseline and day 6

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karsten Koehler, PhD
Organizational Affiliation
University of Nebraska Lincoln
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sports and Exercise Nutrition Laboratory, Department of Nutrition and Health Sciences, Ruth Leverton Hall
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68583
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
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Effect of Caloric Restriction and Protein Intake on Metabolism and Anabolic Sensitivity

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