NCT00143936

Brief Summary

This study will compare the safety and effectiveness of a low carbohydrate diet (Atkins Diet) with a high carbohydrate diet (conventional USDA diet).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
360

participants targeted

Target at P75+ for phase_4 obesity

Timeline
Completed

Started Apr 2003

Longer than P75 for phase_4 obesity

Geographic Reach
1 country

3 active sites

Status
completed

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

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

September 1, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 2, 2005

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2009

Completed
Last Updated

January 15, 2010

Status Verified

January 1, 2008

Enrollment Period

5.8 years

First QC Date

September 1, 2005

Last Update Submit

January 14, 2010

Conditions

Obesity

Keywords

Weight Loss

Outcome Measures

Primary Outcomes (1)

  • Weight loss

    2 years

Study Arms (2)

Low Carb

ACTIVE COMPARATOR

Low Cabohydrate Diet: 20 week of weekly group behavior modification, 20 weekly bi-weekly, bi-monthly to finish

Behavioral: Low- Carbohydrate -Atkins Diet

Low Calorie

ACTIVE COMPARATOR

Low Calorie Diet: 20 weeks of weekly behavior modification, 20 weekly of bi-weekly, bimonthly to finish 2 years

Behavioral: Low Calorie Diet

Interventions

Low- Carbohydrate -Atkins DietBEHAVIORAL

Low Carbohydrate Diet

Also known as: low carb
Low Carb
Low Calorie DietBEHAVIORAL

Maintain a low calorie diet

Also known as: low cal
Low Calorie

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

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 appettite, 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
  • Osteoperosis
  • 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, United States

Location

Washington University

St Louis, Missouri, United States

Location

Temple University

Philadelphia, Pennsylvania, 19140, United States

Location

Related Publications (3)

  • Friedman AN, Ogden LG, Foster GD, Klein S, Stein R, Miller B, Hill JO, Brill C, Bailer B, Rosenbaum DR, Wyatt HR. Comparative effects of low-carbohydrate high-protein versus low-fat diets on the kidney. Clin J Am Soc Nephrol. 2012 Jul;7(7):1103-11. doi: 10.2215/CJN.11741111. Epub 2012 May 31.

    PMID: 22653255DERIVED

  • Borradaile KE, Halpern SD, Wyatt HR, Klein S, Hill JO, Bailer B, Brill C, Stein RI, Miller BV 3rd, Foster GD. Relationship between treatment preference and weight loss in the context of a randomized controlled trial. Obesity (Silver Spring). 2012 Jun;20(6):1218-22. doi: 10.1038/oby.2011.216. Epub 2011 Jul 14.

    PMID: 21760633DERIVED

  • Foster GD, Wyatt HR, Hill JO, Makris AP, Rosenbaum DL, Brill C, Stein RI, Mohammed BS, Miller B, Rader DJ, Zemel B, Wadden TA, Tenhave T, Newcomb CW, Klein S. Weight and metabolic outcomes after 2 years on a low-carbohydrate versus low-fat diet: a randomized trial. Ann Intern Med. 2010 Aug 3;153(3):147-57. doi: 10.7326/0003-4819-153-3-201008030-00005.

    PMID: 20679559DERIVED

MeSH Terms

Conditions

ObesityWeight Loss

Interventions

Caloric Restriction

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBody Weight Changes

Intervention Hierarchy (Ancestors)

Diet TherapyNutrition TherapyTherapeuticsEnergy IntakeDietNutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological Phenomena

Study Officials

  • Gary 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 1, 2005

First Posted

September 2, 2005

Study Start

April 1, 2003

Primary Completion

February 1, 2009

Study Completion

February 1, 2009

Last Updated

January 15, 2010

Record last verified: 2008-01

Locations

US(3)