Trial · NCT00108524
A Low-Carbohydrate, Ketogenic Diet Versus Orlistat for Weight Loss
NCT00108524, Not applicable, Completed, US Department of Veterans Affairs; results first posted 2013-12-12
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Low-Carbohydrate, Ketogenic Diet Versus Orlistat for Weight Loss. Trials, record NCT00108524. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00108524
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Low-Carbohydrate, Ketogenic Diet Versus Orlistat for Weight Loss
- NCT number
- NCT00108524
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 146 participants, actual
- Lead sponsor
- US Department of Veterans Affairs
- Conditions
- Diabetes Mellitus, Obesity
- Interventions
- Low carbohydrate ketogenic diet, Orlistat, Low-fat diet
- First posted
- 2005-04-18
- Last updated
- 2014-04-17
- Results first posted
- 2013-12-12
- Limitations and caveats
We provided orlistat at no cost. This could have increased dietary adherence, attendance, and/or retention compared with the LCKD and may lead to different results than what might be seen in patients who must pay for orlistat.
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in Body Weight at 48 Weeks | baseline and 48 weeks | Body weight was measured using the same calibrated scale (Tanita Corp, Arlington Heights, Illinois) at each visit at the same time of day, with the participant wearing light clothing and no shoes. |
| Secondary | Change From Baseline in Risk Factors for Heart Disease (e.g., Lipid Profiles) at 48 Weeks | baseline and 48 weeks | Measured change in low-density lipoprotein cholesterol, or LDL-C, from baseline to 48 weeks. |
| Secondary | Change From Baseline in Blood Sugar at 48 Weeks | Baseline and 48 weeks | Measured change in Fasting glucose, mg/dL, from baseline to 48 weeks. |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in Body Weight at 48 Weeks | baseline and 48 weeks | percentage of weight loss | MEAN | |
| SECONDARY | Change From Baseline in Risk Factors for Heart Disease (e.g., Lipid Profiles) at 48 Weeks | baseline and 48 weeks | mg/dL | MEAN | |
| SECONDARY | Change From Baseline in Blood Sugar at 48 Weeks | Baseline and 48 weeks | mg/dL | MEAN |
Source ClinicalTrials.gov
Results by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline in Body Weight at 48 Weeks | Arm 1 | -9.5 | 95% Confidence Interval -14.8 to -7.9 | percentage of weight loss | |
| Change From Baseline in Body Weight at 48 Weeks | Arm 2 | -8.5 | 95% Confidence Interval -11.0 to -6.1 | percentage of weight loss | |
| Change From Baseline in Risk Factors for Heart Disease (e.g., Lipid Profiles) at 48 Weeks | Arm 1 | -1.91 | 95% Confidence Interval -8.14 to 4.33 | mg/dL | |
| Change From Baseline in Risk Factors for Heart Disease (e.g., Lipid Profiles) at 48 Weeks | Arm 2 | -8.29 | 95% Confidence Interval -14.06 to -2.52 | mg/dL | |
| Change From Baseline in Blood Sugar at 48 Weeks | Arm 1 | -9.74 | 95% Confidence Interval -16.93 to -2.55 | mg/dL | |
| Change From Baseline in Blood Sugar at 48 Weeks | Arm 2 | -3.54 | 95% Confidence Interval -10.05 to -3.26 | mg/dL |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Low Carbohydrate Ketogenic Diet | 81 | |
| Overall Study | STARTED | Low-Fat Diet Plus Orlistat | 79 | |
| Overall Study | COMPLETED | Low Carbohydrate Ketogenic Diet | 52 | |
| Overall Study | COMPLETED | Low-Fat Diet Plus Orlistat | 61 | |
| Overall Study | NOT COMPLETED | Low Carbohydrate Ketogenic Diet | 29 | |
| Overall Study | NOT COMPLETED | Low-Fat Diet Plus Orlistat | 18 |
Source ClinicalTrials.gov
Adverse events4
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | constipation | Gastrointestinal disorders | Arm 1 | 49 | 72 | 49 |
| other | constipation | Gastrointestinal disorders | Arm 2 | 30 | 74 | 30 |
| serious | gastrointestinal symptoms | Gastrointestinal disorders | Arm 1 | 1 | 72 | 1 |
| serious | gastrointestinal symptoms | Gastrointestinal disorders | Arm 2 | 2 | 74 | 2 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Arm 1 | ||
| Total, all-cause mortality | Arm 2 | ||
| Total, other adverse events | Arm 1 | 49 | 72 |
| Total, other adverse events | Arm 2 | 30 | 74 |
| Total, serious adverse events | Arm 1 | 1 | 72 |
| Total, serious adverse events | Arm 2 | 2 | 74 |
Source ClinicalTrials.gov
Papers3
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Arm 1 vs Arm 2: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00108524
GET https://conductscience.org/api/trials/v1/NCT00108524/registered