ObesityPhase 2NCT00200720
Effectiveness of a Low Carbohydrate Diet Versus a High Carbohydrate Diet in Promoting Weight Loss and Improved Health
A Phase 2 study testing Atkins diet (low carbohydrate diet) and DASH diet (high carbohydrate diet) in people with Obesity and Hypertension, run by Kaiser Permanente at 1 site in United States.
Trial summary
This study will examine the effects of a low carbohydrate diet versus a high carbohydrate diet on weight loss. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Obesity, Hypertension
- What is being tested?
- Atkins diet (low carbohydrate diet) and DASH diet (high carbohydrate diet)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 260 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2005to Jun 2010
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Kaiser Permanente Center for Health Research
Portland, Oregon, 97227
About this study
Official title: Metabolic Consequences of High and Low Carbohydrate Diets
This study will examine the effects of a low carbohydrate diet versus a high carbohydrate diet on weight loss.
Read the detailed description
The number of overweight and obese Americans has increased significantly in recent years. There are now many different diet plans being promoted by doctors and the media. The Atkins diet, a low carbohydrate nutritional plan, is especially popular; its advocates claim that following the diet will result in long-term weight loss with no negative effects. Another diet, called the Dietary Approaches to Stop Hypertension (DASH) diet, is a high carbohydrate diet designed to help treat and prevent high blood pressure. However, more thorough investigation of these claims is needed. This study will compare the short- and long-term effects of the Atkins diet to the (DASH) diet. This trial will enroll overweight and obese participants.
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
- Obesity, Hypertension
- Being tested
- Atkins diet (low carbohydrate diet), DASH diet (high carbohydrate diet)
- Keywords
- Diet, Carbohydrates, Weight Loss
- Medical subject headings
- Obesity, Hypertension, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Atkins diet (low carbohydrate diet)Behavioural
DASH diet (high carbohydrate diet)Behavioural
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: Behavioral: DASH diet (high carbohydrate diet) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight loss
Excess weight loss (greater than 5 pounds a week)would trigger patient assessment.
Measured: monthly
Secondary outcomes (4)
Risk of cardiovascular disease
Elevated lipids or rising blood pressure during six month safety assessments would trigger additional participant evaluation
Measured: Every six months
bone health
Measured: end of study
kidney function
Measured: every six months
neuroendocrine mechanisms of hunger and satiety
Measured: end of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2005 (estimated)
- Study startApr 2005
- Primary completionMar 2009
- Study completionJun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Kaiser PermanenteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 260 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kaiser Permanente
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Responsible party
- Sponsor
- Investigators
- Njeri Karanja, PhD, Principal investigator, Kaiser Permanente
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00200720
- Sponsor's protocol ID
- R21AT000525-01
- Other IDs
- R21AT000525-01, 1R01AT001930
- Status last verified
- Feb 2008
- First submitted
- 12 Sep 2005
- Last updated
- 6 Dec 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metabolic Consequences of High and Low Carbohydrate Diets
- ClinicalTrials.gov ID
- NCT00200720
- Acronym / sponsor ID
- R21AT000525-01
- Conditions
- Obesity, Hypertension
- Keywords
- Diet, Carbohydrates, Weight Loss
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 260 participants (actual)
- Lead sponsor
- Kaiser PermanenteUniversity, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Study start
- Apr 2005
- Primary completion
- Mar 2009 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 20 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will examine the effects of a low carbohydrate diet versus a high carbohydrate diet on weight loss.
Detailed description
The number of overweight and obese Americans has increased significantly in recent years. There are now many different diet plans being promoted by doctors and the media. The Atkins diet, a low carbohydrate nutritional plan, is especially popular; its advocates claim that following the diet will result in long-term weight loss with no negative effects. Another diet, called the Dietary Approaches to Stop Hypertension (DASH) diet, is a high carbohydrate diet designed to help treat and prevent high blood pressure. However, more thorough investigation of these claims is needed. This study will compare the short- and long-term effects of the Atkins diet to the (DASH) diet. This trial will enroll overweight and obese participants.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Atkins Diet | Experimental | Behavioral: Atkins diet (low carbohydrate 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. |
| DASH Diet | Active comparator | Behavioral: DASH diet (high carbohydrate 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 |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Atkins diet (low carbohydrate diet) | Behavioural | Atkins Diet |
| DASH diet (high carbohydrate diet) | Behavioural | DASH Diet |
Primary outcome
Weight loss
Time frame: monthly
Excess weight loss (greater than 5 pounds a week)would trigger patient assessment.
4 secondary outcomes
Risk of cardiovascular disease
Time frame: Every six months
bone health
Time frame: end of study
kidney function
Time frame: every six months
neuroendocrine mechanisms of hunger and satiety
Time frame: end of study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Njeri Karanja, PhD principal investigator
Kaiser Permanente
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Atkins diet (low carbohydrate diet) and DASH diet (high carbohydrate diet) in people with Obesity and Hypertension, run by Kaiser Permanente at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Dec 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weight loss (time frame: monthly). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2012.