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

NCT02945410 | Completed Results

• 1 other identifier: 15895
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Conditions

Weight Loss; Starvation

Outcome Measures

Primary Outcomes (4)

• Change in Resting Metabolic Rate

  Baseline and day 6

• Change in Circulating IGF-1

  Baseline and day 6

• Change in Marker of Bone Formation (P1NP)

  Baseline and day 6

• Change in Marker of Bone Resorption (CTx)

  Baseline and day 6

Secondary Outcomes (4)

• 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

• Change in Perceived Hunger

  Baseline and day 6

Study Arms (3)

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.

Other: Caloric Restriction; Other: Protein; Other: Exercise; Dietary Supplement: Calcium and Vitamin D; Other: Maltodextrin

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.

Other: Caloric Restriction; Other: Exercise; Dietary Supplement: Calcium and Vitamin D; Other: Maltodextrin

Energy Balance

PLACEBO COMPARATOR

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

Other: Protein; Other: Exercise; Dietary Supplement: Calcium and Vitamin D; Other: Maltodextrin

Interventions

Caloric Restriction OTHER

Participants will consume 30 kcal/kg FFM/day.

Caloric Restriction and High Protein; Caloric Restriction and Normal Protein

Protein OTHER

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

Caloric Restriction and High Protein; Energy Balance

Exercise OTHER

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

Caloric Restriction and High Protein; Caloric Restriction and Normal Protein; Energy Balance

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

Caloric Restriction and High Protein; Caloric Restriction and Normal Protein; Energy Balance

Maltodextrin OTHER

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

Caloric Restriction and High Protein; Caloric Restriction and Normal Protein; Energy Balance

Eligibility Criteria

• Age: 19 Years - 30 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Nebraska Lincoln: lead

Study Sites (1)

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

Lincoln, Nebraska, 68583, United States

Location

Related Publications (19)

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  PMID: 19127177 BACKGROUND

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  PMID: 10865771 BACKGROUND

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  PMID: 24595305 BACKGROUND

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  PMID: 24945715 BACKGROUND

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  PMID: 21177945 BACKGROUND

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  PMID: 24307968 BACKGROUND

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  PMID: 25614201 BACKGROUND

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  PMID: 14974441 BACKGROUND

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  PMID: 21228564 BACKGROUND

• Ihle R, Loucks AB. Dose-response relationships between energy availability and bone turnover in young exercising women. J Bone Miner Res. 2004 Aug;19(8):1231-40. doi: 10.1359/JBMR.040410. Epub 2004 Apr 19.

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• De Souza MJ, Williams NI. Beyond hypoestrogenism in amenorrheic athletes: energy deficiency as a contributing factor for bone loss. Curr Sports Med Rep. 2005 Feb;4(1):38-44. doi: 10.1007/s11932-005-0029-1.

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  PMID: 17892378 BACKGROUND

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  PMID: 21118827 BACKGROUND

MeSH Terms

Conditions

Weight Loss; Starvation

Interventions

Caloric Restriction; Proteins; Exercise; Calcium; Vitamin D; maltodextrin

Condition Hierarchy (Ancestors)

Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Diet Therapy; Nutrition Therapy; Therapeutics; Energy Intake; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Amino Acids, Peptides, and Proteins; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Metals, Alkaline Earth; Elements; Inorganic Chemicals; Metals; Blood Coagulation Factors; Biological Factors; Secosteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Results Point of Contact

• Title: Dr. Karsten Koehler
• Organization: Technical University of Munich

karsten.koehler@tum.de

+49 89 289 24488

Study Officials

• Karsten Koehler, PhD

  University of Nebraska Lincoln

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 10, 2016
• First Posted: October 26, 2016
• Study Start: September 1, 2016
• Primary Completion: February 1, 2019
• Study Completion: February 1, 2019
• Last Updated: December 19, 2019
• Results First Posted: December 19, 2019

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)