Ignite Creation Date:
2024-05-05 @ 6:31 PM
Last Modification Date:
2024-10-26 @ 9:34 AM
Study NCT ID:
NCT00498394
Status:
COMPLETED
Last Update Posted:
2007-07-10
First Post:
2007-07-06
Brief Title:
Effects of a Ketogenic Diet on Body Weight and Cardiovascular Risk Factors
Sponsor:
University of Cincinnati
Organization:
University of Cincinnati
Study Overview
Official Title:
Effects of a Ketogenic Diet on Body Weight and Cardiovascular Risk Factors
Status:
COMPLETED
Status Verified Date:
2007-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This pilot study is a randomized controlled clinical trial to compare anthropometric and metabolic changes associated with six months of weight management by means of a very low carbohydrate diet or a calorically-restricted low fat diet We hypothesized that the low fat diet would be associated with more weight loss and improvement of cardiovascular risk factors than the low carbohydrate diet
Detailed Description:
Low carbohydrate diets including high-fat ketogenic diets have moved to the forefront of popular diets promoted for weight loss in the United States These diet plans have been aggressively marketed to millions of Americans every year However there has been virtually no rigorous study of low carbohydrate high fat diets either with regard to efficacy in promoting weight loss or effects on cardiovascular risk factors Because very low carbohydrate diets ie the ketogenic diets recommend increased intake of fat and saturated fat we hypothesized that following one of these diet plans could actually worsen important risk factors for cardiovascular disease This is an issue of great importance because large numbers of people experiment with low carbohydrate diets despite not knowing their effects on blood pressure plasma lipid levels and glucose tolerance Therefore we have proposed a clinical trial to test our hypothesis In this study we will compare the effects of three months of a ketogenic diet as promoted by Dr Robert Atkins with three months of a weight loss diet that conforms to the American Heart Association dietary guidelines in a group of 100 otherwise healthy obese subjects During the course of the study we will determine the effects of diet on 1 body weight percent fat and resting metabolic rate 2 blood pressure 3 plasma lipids 4 measures of glucose tolerance and 5 measures of psychological health and eating behaviors This pilot study will provide the preliminary data needed to demonstrate the efficacy or lack thereof of a popular weight loss technique ie the ketogenic diet that is currently being criticized by professional organizations Armed with preliminary data the investigators plan to further investigate the long-term anthropometric and metabolic effects of ketogenic diets with a larger sample
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None