NCT00143962

Brief Summary

This is a follow-up research study to determine if there are any differences in the long-term maintenance of two diet groups, the Atkins' diet (low-carbohydrate) or the LEARN program (low-fat). The Atkins' diet continues to get a significant amount of popular attention and very little scientific evaluation. Due to the small amount of scientific data to support a low-carbohydrate diet and given the wide spread use of this type of diet, it is important to evaluate the long-term safety and effectiveness of the Atkins' diet. We will evaluate whether there are any differences between these two groups 3-years after participation in the initial 1-year study period. We will specifically assess weight, cholesterol levels, glucose and insulin levels, and eating habits and mood as we did originally.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
6

participants targeted

Target at below P25 for phase_4 obesity

Timeline
Completed

Started Jul 2004

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

July 1, 2004

Completed
1.2 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
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2006

Completed
Last Updated

August 17, 2016

Status Verified

August 1, 2016

Enrollment Period

1.7 years

First QC Date

September 1, 2005

Last Update Submit

August 15, 2016

Conditions

Obesity

Keywords

Weight Loss

Outcome Measures

Primary Outcomes (1)

  • Obesity

Interventions

Low Carbohydrate DietBEHAVIORAL

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

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, United States

Location

Washington University

St Louis, Missouri, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Location

Related Publications (1)

  • Foster GD, Wyatt HR, Hill JO, McGuckin BG, Brill C, Mohammed BS, Szapary PO, Rader DJ, Edman JS, Klein S. A randomized trial of a low-carbohydrate diet for obesity. N Engl J Med. 2003 May 22;348(21):2082-90. doi: 10.1056/NEJMoa022207.

    PMID: 12761365BACKGROUND

MeSH Terms

Conditions

ObesityWeight Loss

Interventions

Diet, Carbohydrate-Restricted

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Diet TherapyNutrition TherapyTherapeuticsDietNutritional 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

July 1, 2004

Primary Completion

March 1, 2006

Study Completion

March 1, 2006

Last Updated

August 17, 2016

Record last verified: 2016-08

Locations

US(3)