N/A N=15 Randomized Single-blind Prevention

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

Weight Loss · Starvation

Bottom Line

View on ClinicalTrials.gov: NCT02945410 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Dec 2019

Primary outcome: Primary: Change in Resting Metabolic Rate — -63.4; -77.6; -47.4 kcal change

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Caloric Restriction (Other); Protein (Other); Exercise (Other); Calcium and Vitamin D (Dietary_supplement); Maltodextrin (Other)
Age: Adult · 19+ yrs
Sex: Male
Sponsor: University of Nebraska Lincoln
Primary completion: Feb 2019

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in Resting Metabolic Rate	-63.4; -77.6; -47.4	—
PRIMARY Change in Circulating IGF-1	-2.3195714; -0.2107857; -1.1142857	—
PRIMARY Change in Marker of Bone Formation (P1NP)	3.73; 4.80; -3.24	—
PRIMARY Change in Marker of Bone Resorption (CTx)	0.24; 6.93; -8.34	—
SECONDARY Change in Body Weight	-2.3; -2.1; -0.0	—
SECONDARY Change in Body Fat Percentage	-0.94; -0.23; -0.08	—
SECONDARY Change in Aerobic Fitness (VO2peak)	0.25; 0.01; 0.01	—
SECONDARY Change in Perceived Hunger	18.4; 27.3; 10.3	—

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

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

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Data sourced from ClinicalTrials.gov (NCT02945410). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.