The Safety and Effectiveness of Low and High Carbohydrate Diets
The Safety and Efficacy of Low and High Carbohydrate Diets
1 other identifier
interventional
307
1 country
3
Brief Summary
This study will compare the safety and the effectiveness of a low carbohydrate diet (Atkins diet) with a high carbohydrate diet (conventional USDA diet).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4 obesity
Started Apr 2003
Longer than P75 for phase_4 obesity
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2003
CompletedFirst Submitted
Initial submission to the registry
March 9, 2004
CompletedFirst Posted
Study publicly available on registry
March 10, 2004
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2008
CompletedJuly 1, 2013
January 1, 2008
4.9 years
March 9, 2004
June 28, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
weight change
2 years
Secondary Outcomes (8)
change in lipids
2 years
blood pressure change
2 years
Ketones
2 years
Endothelial Function
2
change in exercise endurance
2 years
- +3 more secondary outcomes
Study Arms (2)
1
ACTIVE COMPARATORLow-calorie diet
2
EXPERIMENTALLow-carbohydrate diet
Interventions
Eligibility Criteria
You may qualify if:
- Body mass index between 30 and 40
- Live and work within 1 hour of the study site
- Stable psychological status
You may not qualify if:
- History of heart disease, heart attack, or stroke
- Blood pressure \>140/90 mmHg
- Abnormal cholesterol levels
- Significant psychiatric illness
- Any medication that affects weight or metabolic rate
- Presence or history of a chronic disease that is known to affect appetite, food intake, or metabolism (i.e., diabetes, thyroid disease, or cancer)
- Currently using antidepressants, steroids, tobacco, or illegal drugs
- Pregnant, breastfeeding, or planning pregnancy
- lb change in weight within 6 months of study entry
- History of malignant arrhythmias or cerebrovascular, renal, or hepatic disease
- History of protein wasting diseases or gout
- Severe arthritis
- Osteoporosis
- Certain types of hormone replacement therapy
- Currently following a vegetarian diet
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
University of Colorado
Denver, Colorado, 80262, United States
Washington University
St Louis, Missouri, 63110, United States
University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
Related Publications (1)
de las Fuentes L, Waggoner AD, Mohammed BS, Stein RI, Miller BV 3rd, Foster GD, Wyatt HR, Klein S, Davila-Roman VG. Effect of moderate diet-induced weight loss and weight regain on cardiovascular structure and function. J Am Coll Cardiol. 2009 Dec 15;54(25):2376-81. doi: 10.1016/j.jacc.2009.07.054.
PMID: 20082927DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Gary D Foster, PhD
University of Pennsylvania
- PRINCIPAL INVESTIGATOR
Holly Wyatt, MD
University of Colorado, Denver
- PRINCIPAL INVESTIGATOR
James Hill, PhD
University of Colorado, Denver
- PRINCIPAL INVESTIGATOR
Samuel Klein, MD
Washington University School of Medicine
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 9, 2004
First Posted
March 10, 2004
Study Start
April 1, 2003
Primary Completion
March 1, 2008
Study Completion
March 1, 2008
Last Updated
July 1, 2013
Record last verified: 2008-01