Effectiveness of a Low Carbohydrate Diet Versus a High Carbohydrate Diet in Promoting Weight Loss and Improved Health
NCT ID: NCT00200720
Last Updated: 2012-12-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
260 participants
INTERVENTIONAL
2005-04-30
2010-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
This study will last 30 months and will comprise two phases. Participants will be randomly assigned to either the Atkins or DASH diet for 30 months. During Phase 1, all participants will undergo 6 months of weekly group therapy to encourage weight loss. Phase 2 is a weight loss maintenance phase. During Phase 2, participants will have monthly meetings with a therapist for weight loss support. Study visits will occur at study entry and at Months 3 and 30. At each study visit, weight measurements, blood and urine collection, and x-rays will occur to determine participants' weight loss, cardiovascular health, kidney function, and bone density.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Atkins Diet
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.
Atkins diet (low carbohydrate diet)
DASH Diet
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
DASH diet (high carbohydrate diet)
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Atkins diet (low carbohydrate diet)
DASH diet (high carbohydrate diet)
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
Exclusion Criteria
* 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
21 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National Center for Complementary and Integrative Health (NCCIH)
NIH
Kaiser Permanente
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Njeri Karanja, PhD
Role: PRINCIPAL_INVESTIGATOR
Kaiser Permanente
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Kaiser Permanente Center for Health Research
Portland, Oregon, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.