N/A
N=39
Effect of Caloric Restriction on Fat Oxidation in Obese Men and Women (Magellan II)
Obesity · Overweight · Metabolic Diseases
Bottom Line
View on ClinicalTrials.gov: NCT01616082 ↗Enrolled (actual)
39
Serious AEs
0.0%
Results posted
Nov 2020
Primary outcome: Primary: Change From Baseline Amount of Fat Oxidation at 14 Days — 0.91; 0.94 Fold change of RQ ratio
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Low Calorie Diet (LCD) (Behavioral); Phentermine (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- AdventHealth Translational Research Institute
- Primary completion
- Nov 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline Amount of Fat Oxidation at 14 Days |
0.91; 0.94 | — |
| PRIMARY Fat Oxidation Rates at 1 Week Intervals |
0.867; 0.857; 0.795; 0.787; 0.791; 0.801 | — |
| SECONDARY Soleus IMCL Content |
0.025; 0.032; 0.028; 0.034; 0.030; 0.034 | — |
Summary
The purpose of this study is to better understand the different ways our bodies burn fat which may be important for obesity, diabetes, and cardiovascular disease.
Eligibility Criteria
Inclusion Criteria
- Male or female subjects between the ages of 18 and 55 years, inclusive
- Body Mass Index (BMI) 27-30 kg/m2, inclusive, with hypertension, controlled ( 2years) unwilling to use an approved method of contraception (condom, diaphragm, implantable uterine device (IUD) that does not release hormones).
- Prior participation in the Magellan I study at the Translational Research Institute for Metabolism and Diabetes.
Data sourced from ClinicalTrials.gov (NCT01616082). 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.