N/A
Completed N=15
Effect of Caloric Restriction and Protein Intake on Metabolism and Anabolic Sensitivity
Weight Loss · Starvation
Source: ClinicalTrials.gov NCT02945410 ↗
Enrolled (actual)
15
Serious AEs
0.0%
Results posted
Dec 2019
Primary outcomePrimary: Change in Resting Metabolic Rate — -63.4; -77.6; -47.4 kcal change
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
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 | — |
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
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. Informational only — not medical advice.