MedTrace Logo

Effect of Caloric Restriction on Fat Oxidation in Obese Men and Women (Magellan II)

NCT01616082 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 39

Last updated 2020-11-13

Study results available
· View outcomes & findings →

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.

Conditions

Interventions

BEHAVIORAL

Low Calorie Diet (LCD)

A Diet History Questionnaire was completed and subjects had dietary counseling and were provided shakes. The low calorie diet began, to continued for a period of 8 weeks.

DRUG

Phentermine

Individuals not on track to achieve their target weight by four weeks received the drug Phentermine to promote weight loss. Then, following eight weeks LCD (or four weeks LCD + four weeks LCD+Phentermine), in the event that they did not achieve the target weight loss, subjects were given the option to continue with the LCD + Phentermine for up to an additional 12 weeks, under a doctor's supervision. Protection Against Risk: * Prior to administering any phentermine, a history and physical including EKG will be conducted (at the screening visit) and will be used to determine whether the participant is clear to receive the medication. * Participants will see the study doctor or nurse practitioner at every study visit after the drug is initiated.

Sponsors & Collaborators

  • Takeda

    collaborator INDUSTRY

  • AdventHealth Translational Research Institute

    lead OTHER

Principal Investigators

  • Steven R Smith, MD · Translational Research Institute for Metabolism and Diabetes

Study Design

Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-09-30
Primary Completion
2012-11-30
Completion
2012-11-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01616082 on ClinicalTrials.gov