ObesityPhase 4NCT00143936
The Safety and Efficacy of Low and High Carbohydrate Diets
A Phase 4 study testing Low- Carbohydrate -Atkins Diet and Low Calorie Diet in people with Obesity, run by Temple University at 3 sites in United States.
Trial summary
This study will compare the safety and effectiveness of a low carbohydrate diet (Atkins Diet) with a high carbohydrate diet (conventional USDA diet). Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Low- Carbohydrate -Atkins Diet and Low Calorie Diet
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 360 participants
- Where
- 3 sitesUnited States
- Study dates
- Apr 2003to Feb 2009
- Phase
- Phase 4
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Body mass index between 30 and 40
- Live and work within 1 hour of the study site
- Stable psychological status
Who cannot join
- 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).
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- Currently using antidepressants, steroids, tobacco or illegal drugs
- Pregnant, breastfeeding, or planning pregnancy
- 10 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
Trial locations and contacts
3 sites in 1 country.
United States3 sites
University of Colorado
Denver, Colorado
Temple University
Philadelphia, Pennsylvania, 19140
Washington University
St Louis, Missouri
About this study
This study will compare the safety and effectiveness of a low carbohydrate diet (Atkins Diet) with a high carbohydrate diet (conventional USDA diet).
Read the detailed description
Despite the considerable mass appeal of popular diet books, such diet approaches lack data to support their efficacy and safety. Despite its widespread use for more than 30 years, the Atkins diet has never been evaluated in a large, randomized, controlled trial. This study will assess the short-term and long-term clinical effects of a low-carbohydrate diet and a high-carbohydrate diet in overweight and obese men and women.
Participants in this study will be randomly assigned to the Atkins diet (low-carbohydrate, unlimited fat and protein) or a conventional USDA diet (high-carbohydrate, low fat). The study will evaluate the effects of each dietary approach on changes in: 1) weight and body composition, 2) metabolic and organ function, 3) exercise tolerance. Each participant will be enrolled in the study for 2 years.
- Conditions
- Obesity
- Being tested
- Low- Carbohydrate -Atkins Diet, Low Calorie Diet
- Keywords
- Weight Loss
- Medical subject headings
- Obesity, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low- Carbohydrate -Atkins DietBehavioural
Also called low carb
Low Carbohydrate Diet
Low Calorie DietBehavioural
Also called low cal
Maintain a low calorie diet
| Study group | Role | What they receive |
|---|---|---|
| Low Carb | Active comparator | Low Cabohydrate Diet: 20 week of weekly group behavior modification, 20 weekly bi-weekly, bi-monthly to finish Receives: 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 Receives: Behavioral: Low Calorie Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight loss
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2005 (estimated)
- Study startApr 2003
- Primary completionFeb 2009
- Study completionFeb 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 360 participants (actual)
Sponsor and investigators
- Lead sponsor
- Temple University
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH), National Institutes of Health (NIH)
- Investigators
- Gary Foster, PhD, Principal investigator, University of PennsylvaniaHolly Wyatt, MD, Principal investigator, University of Colorado, DenverJames Hill, PhD, Principal investigator, University of Colorado, DenverSamuel Klein, MD, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00143936
- Sponsor's protocol ID
- R01AT001103
- Other IDs
- 1R01AT001103-01
- Status last verified
- Jan 2008
- First submitted
- 1 Sep 2005
- Last updated
- 15 Jan 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 22653255Borradaile 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.
PubMed 21760633Foster 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.
PubMed 20679559
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Safety and Efficacy of Low and High Carbohydrate Diets
- ClinicalTrials.gov ID
- NCT00143936
- Acronym / sponsor ID
- R01AT001103
- Conditions
- Obesity
- Keywords
- Weight Loss
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 360 participants (actual)
- Lead sponsor
- Temple UniversityUniversity, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH), National Institutes of Health (NIH)
- Study start
- Apr 2003
- Primary completion
- Feb 2009 (actual)
- Study completion
- Feb 2009 (actual)
- First posted
- 2 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 compare the safety and effectiveness of a low carbohydrate diet (Atkins Diet) with a high carbohydrate diet (conventional USDA diet).
Detailed description
Despite the considerable mass appeal of popular diet books, such diet approaches lack data to support their efficacy and safety. Despite its widespread use for more than 30 years, the Atkins diet has never been evaluated in a large, randomized, controlled trial. This study will assess the short-term and long-term clinical effects of a low-carbohydrate diet and a high-carbohydrate diet in overweight and obese men and women.
Participants in this study will be randomly assigned to the Atkins diet (low-carbohydrate, unlimited fat and protein) or a conventional USDA diet (high-carbohydrate, low fat). The study will evaluate the effects of each dietary approach on changes in: 1) weight and body composition, 2) metabolic and organ function, 3) exercise tolerance. Each participant will be enrolled in the study for 2 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low Carb | Active comparator | Behavioral: Low- Carbohydrate -Atkins DietLow Cabohydrate Diet: 20 week of weekly group behavior modification, 20 weekly bi-weekly, bi-monthly to finish |
| Low Calorie | Active comparator | Behavioral: Low Calorie DietLow Calorie Diet: 20 weeks of weekly behavior modification, 20 weekly of bi-weekly, bimonthly to finish 2 years |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Body mass index between 30 and 40
- Live and work within 1 hour of the study site
- Stable psychological status
Key exclusion criteria (15 listed)
- 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
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 |
|---|---|---|
| Low- Carbohydrate -Atkins DietAlso: low carbLow Carbohydrate Diet | Behavioural | Low Carb |
| Low Calorie DietAlso: low calMaintain a low calorie diet | Behavioural | Low Calorie |
Primary outcome
Weight loss
Time frame: 2 years
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 15 Jan 2010.
- Derived from this study: PubMed 22653255Friedman 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.
- Derived from this study: PubMed 21760633Borradaile 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.
- Derived from this study: PubMed 20679559Foster 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.
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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.
Gary Foster, PhD principal investigator
University of Pennsylvania
Holly Wyatt, MD principal investigator
University of Colorado, Denver
James Hill, PhD principal investigator
University of Colorado, Denver
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Low- Carbohydrate -Atkins Diet and Low Calorie Diet in people with Obesity, run by Temple University at 3 sites 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 3 inclusion and 15 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 15 Jan 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00143936, which also lists 3 linked publications.
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 15 Jan 2010.