CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 146 enrolled
Drug / intervention
Orlistat +2 moredrug
Likely dose
Orlistat 3 times daily (specific dose not stated)AI-extracted
Key inclusion· 6
  • ✓BMI ≥27 with obesity-related illness OR BMI ≥30 with no risk factors
  • ✓Failed first-line diet and exercise recommendations
  • ✓Stable health by screening physical and lab tests
  • ✓VA medical center primary care provider
Key exclusion· 5
  • ✕BMI <27
  • ✕Contraindications to Orlistat
  • ✕Pregnancy, breast-feeding, or planning to become pregnant
  • ✕Serious or unstable mental health illness (dementia, schizophrenia)

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00108524
NCT00108524N/ACompleted
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A Low-Carbohydrate, Ketogenic Diet Versus Orlistat for Weight Loss

US Department of Veterans Affairs·interventional·Posted Apr 18, 2005·Updated Apr 17, 2014

In Brief

A clinical study evaluating Low carbohydrate ketogenic diet, Orlistat, and 1 other intervention for Diabetes Mellitus and Obesity. Completed, enrolled 146 participants across 1 site.

Detailed Summary

This study compares two types of diet interventions: a low carbohydrate ketogenic diet (Atkins) and a low-fat diet combined with a medication (Orlistat).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetes Mellitus, Obesity
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedApr 18, 2005
Enrollment StartJul 1, 2004
Primary CompletionDec 1, 2007
TodayJul 2, 2026
Enrollment to primary: 3.4 yearsPosted 21.2 years ago

Interventions

Low carbohydrate ketogenic dietbehavioral

A low-carb diet limits carbohydrates - such as grains, starchy vegetables and fruit - and emphasizes dietary protein and fat.

Orlistatdrug

In addition to the low fat diet, Orlistat is taken 3 times daily.

Low-fat dietbehavioral

Participants receive counseling on a low fat diet over 48 weeks aimed at reducing fat and calorie intake