NCT00200720

Brief Summary

This study will examine the effects of a low carbohydrate diet versus a high carbohydrate diet on weight loss.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
260

participants targeted

Target at P75+ for phase_2 obesity

Timeline
Completed

Started Apr 2005

Longer than P75 for phase_2 obesity

Geographic Reach
1 country

1 active site

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, 2005

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 20, 2005

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2009

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2010

Completed
Last Updated

December 6, 2012

Status Verified

February 1, 2008

Enrollment Period

3.9 years

First QC Date

September 12, 2005

Last Update Submit

December 4, 2012

Conditions

ObesityHypertension

Keywords

DietCarbohydratesWeight Loss

Outcome Measures

Primary Outcomes (1)

  • Weight loss

    Excess weight loss (greater than 5 pounds a week)would trigger patient assessment.

    monthly

Secondary Outcomes (4)

  • Risk of cardiovascular disease

    Every six months

  • bone health

    end of study

  • kidney function

    every six months

  • neuroendocrine mechanisms of hunger and satiety

    end of study

Study Arms (2)

Atkins Diet

EXPERIMENTAL

Participants randomized to this arm will consume a low carbohydrate diet as described by Dr. Robert Atkins in his book: Dr. Atkins' New Diet Revolution New York: Avon Books, 2002.

Behavioral: Atkins diet (low carbohydrate diet)

DASH Diet

ACTIVE COMPARATOR

Participants randomized to this arm will consume the Dietary Approaches to Stop Hypertension (DASH) diet as described here: http://www.nhlbi.nih.gov/health/public/heart/hbp/dash/new\_dash.pdf

Behavioral: DASH diet (high carbohydrate diet)

Interventions

Atkins diet (low carbohydrate diet)BEHAVIORAL
Atkins Diet
DASH diet (high carbohydrate diet)BEHAVIORAL
DASH Diet

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Body mass index (BMI) of 27 to 50
  • Fasting glucose less than 126 mg/dl
  • Total fasting cholesterol less than 260 mg/dl
  • Total fasting triglycerides less than 400 mg/dl
  • Permission of primary care provider to participate in the study
  • Normal liver and kidney function
  • Willing to modify diet and other health behaviors
  • Willing to use an acceptable method of contraception for the duration of the study

You may not qualify if:

  • Any medical condition that may make weight loss medically inadvisable
  • Weigh more than 400 lbs
  • History of kidney failure
  • Current use of more than 3 blood pressure medications
  • Change in blood pressure medications within 3 months prior to study entry
  • Diagnosis of cardiovascular disease within 6 months prior to study entry
  • Cancer diagnosis within 2 years of study entry. Participants with basal cell skin cancer are not excluded.
  • History of psychiatric hospitalization within 2 years prior to study entry
  • Consumption of more than three alcoholic drinks a day
  • Type I or II diabetes
  • Current use of hypolipidemics, antipsychotics, hypoglycemics, glucocorticoids, or thyroid medication
  • Plan to move during study
  • Current participation in another clinical trial
  • Pregnancy or breastfeeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kaiser Permanente Center for Health Research

Portland, Oregon, 97227, United States

Location

MeSH Terms

Conditions

ObesityHypertensionWeight Loss

Interventions

Diet, High-Protein Low-CarbohydrateDiet, Carbohydrate-RestrictedDietary Approaches To Stop Hypertension

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Diet TherapyNutrition TherapyTherapeuticsDiet, High-ProteinDietNutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological Phenomena

Study Officials

  • Njeri Karanja, PhD

    Kaiser Permanente

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 20, 2005

Study Start

April 1, 2005

Primary Completion

March 1, 2009

Study Completion

June 1, 2010

Last Updated

December 6, 2012

Record last verified: 2008-02

Locations

US(1)