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Completed

NCT Number: NCT02945410

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

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

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Key information

Age range

19 year–30 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

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

Lincoln, Nebraska, 68583, United States

About this study

  • 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Caloric restriction

Other

Participants will consume 30 kcal/kg FFM/day.

Protein

Other

Participants will consume 1.7 g protein/kg BW/day.

Exercise

Other

Participants will conduct aerobic exercise designed to expend 15 kcal/kg FFM/day

Calcium and Vitamin D

Dietary Supplement

Participants will be provided calcium and vitamin D supplement in order to maintain calcium and Vitamin D intake constant across all study arms

maltodextrin

Other

Participants will be provided with maltodextrin to supplement the liquid diet in order to meet caloric needs within each study arm

Primary outcomes

  1. Change in Resting Metabolic Rate

    Time frame: Baseline and day 6

  2. Change in Circulating IGF-1

    Time frame: Baseline and day 6

  3. Change in Marker of Bone Formation (P1NP)

    Time frame: Baseline and day 6

  4. Change in Marker of Bone Resorption (CTx)

    Time frame: Baseline and day 6

Secondary outcomes

  1. Change in Body Weight

    Time frame: Baseline and day 6

  2. Change in Body Fat Percentage

    Time frame: Baseline and day 6

  3. 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.

  4. 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.

Sponsors and collaborators

Lead sponsor

University of Nebraska Lincoln

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Oct 26, 2016
Registry last updated
Dec 19, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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