ObesityNCT01034046
Weight Loss and Abdominal Fat Responses to Different Diet Compositions
A study testing Low Carbohydrate Diet and Low Fat Diet in people with Obesity and Insulin Resistance, run by University of Nevada, Las Vegas at 1 site in United States.
Trial summary
The purpose of this study is to assess the effectiveness of two different reduced calorie diets that have different combinations of carbohydrate, fat, and protein content in 2 groups of study participants: insulin sensitive participants and insulin resistant participants. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Obesity, Insulin Resistance, Metabolic Syndrome
- What is being tested?
- Low Carbohydrate Diet and Low Fat Diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2009to Jun 2011
- Phase
- Interventional
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Females between 18 and 65 years of age.
- BMI 30-40 kg/m2
- Stable weight within 10 lb (+/-) for last 2 months
Who cannot join
- Pregnant or lactating.
- Must not currently be part of a structured weight loss program
- Taking a medication for diabetes (such as insulin, metformin, glyburide, glipizide, Byetta, pioglitazone, or rosiglitazone) or a medication such as systemic glucocorticoids that are known to affect blood sugar or blood insulin.
- Beck Depression Inventory (BDI Score >19 and/or positively endorses the suicide question on the BDI-II)
- Taking any chronic medication that has not had a stable dose for 1 month or longer.
- Diabetes mellitus defined as a fasting glucose ≥ 126 mg/dL on screening.
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- Taking medications or dietary supplements that cause weight gain or weight loss (eg. antipsychotics (Seroquel, Zyprexa, and Risperdal) and/or anorectics).
- Clinically significant laboratory abnormalities at the opinion of the investigators.
- History of Bariatric Surgery
- A history of:
- Type 2 diabetes, type 1 diabetes, or diabetes that is a result of pancreatic injury, or secondary forms of diabetes, e.g. Cushing's syndrome and acromegaly.
- Liver disease, such as cirrhosis, or chronic active hepatitis B or C.
- Use of investigational drugs within 30 days of visit 1
- A pacemaker.
- Hospitalization for depression in the past 6 months, history of moderate to severe major depression.
- Any other condition that in the investigators' or sponsor's opinion could interfere with the results of the trial.
Trial locations and contacts
1 site in 1 country.
United States1 site
Center for Nutrition and Metabolism at the University of Nevada School of Medicine, Reno
Reno, Nevada, 89557
About this study
Official title: Weight Loss and Visceral Fat Responses to Different Diet Compositions
The purpose of this study is to assess the effectiveness of two different reduced calorie diets that have different combinations of carbohydrate, fat, and protein content in 2 groups of study participants: insulin sensitive participants and insulin resistant participants. The hypothesis of the study is that people with high and low levels of insulin resistance may respond differently to different diet compositions in a real-world environment using meals that are commonly available.
- Conditions
- Obesity, Insulin Resistance, Metabolic Syndrome
- Being tested
- Low Carbohydrate Diet, Low Fat Diet
- Keywords
- Obesity
- Medical subject headings
- Obesity, Insulin Resistance, Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low Carbohydrate DietOther
Low carbohydrate diet (45% carbohydrate, 35% fat and 20% protein diet) administered utilizing meal replacements.
Low Fat DietOther
Low fat diet (60% carbohydrate, 20% fat and 20% protein diet) administered utilizing meal replacements.
| Study group | Role | What they receive |
|---|---|---|
| Insulin Sensitive Study Participants | Active comparator | Insulin sensitive subjects stratified using fasting insulin levels. Receives: Other: Low Carbohydrate Diet; Other: Low Fat Diet |
| Insulin Resistant Study Subjects | Active comparator | Insulin resistant subjects stratified using fasting insulin levels. Receives: Other: Low Carbohydrate Diet; Other: Low Fat Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in weight in kg
Measured: 24 weeks
Secondary outcomes (1)
Change in visceral fat via bioimpedance
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2009 (estimated)
- Study startApr 2009
- Primary completionJun 2011 (estimated)
- Study completionJun 2011 (estimated)
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.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Nevada, Las Vegas
- Sponsor type
- University, hospital or other
- Collaborators
- Jenny Craig, Inc.
- Investigators
- Raymond A Plodkowski, MD, Principal investigator, University of Nevada School of Medicine, RenoSachiko T St. Jeor, PhD, RD, Principal investigator, University of Nevada School of Medicine, Reno
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01034046
- Sponsor's protocol ID
- B08/09-031
- Status last verified
- Dec 2009
- First submitted
- 16 Dec 2009
- Last updated
- 30 Apr 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Weight Loss and Visceral Fat Responses to Different Diet Compositions
- ClinicalTrials.gov ID
- NCT01034046
- Acronym / sponsor ID
- B08/09-031
- Conditions
- Obesity, Insulin Resistance, Metabolic Syndrome
- Keywords
- Obesity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of Nevada, Las VegasUniversity, hospital or other
- Collaborators
- Jenny Craig, Inc.
- Study start
- Apr 2009
- Primary completion
- Jun 2011 (estimated)
- Study completion
- Jun 2011 (estimated)
- First posted
- 17 Dec 2009 (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.
The purpose of this study is to assess the effectiveness of two different reduced calorie diets that have different combinations of carbohydrate, fat, and protein content in 2 groups of study participants: insulin sensitive participants and insulin resistant participants. The hypothesis of the study is that people with high and low levels of insulin resistance may respond differently to different diet compositions in a real-world environment using meals that are commonly available.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Insulin Sensitive Study Participants | Active comparator | Other: Low Carbohydrate Diet, Other: Low Fat DietInsulin sensitive subjects stratified using fasting insulin levels. |
| Insulin Resistant Study Subjects | Active comparator | Other: Low Carbohydrate Diet, Other: Low Fat DietInsulin resistant subjects stratified using fasting insulin levels. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Females between 18 and 65 years of age.
- BMI 30-40 kg/m2
- Stable weight within 10 lb (+/-) for last 2 months
Key exclusion criteria (16 listed)
- Pregnant or lactating.
- Must not currently be part of a structured weight loss program
- Taking a medication for diabetes (such as insulin, metformin, glyburide, glipizide, Byetta, pioglitazone, or rosiglitazone) or a medication such as systemic glucocorticoids that are known to affect blood sugar or blood insulin.
- Beck Depression Inventory (BDI Score >19 and/or positively endorses the suicide question on the BDI-II)
- Taking any chronic medication that has not had a stable dose for 1 month or longer.
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 DietLow carbohydrate diet (45% carbohydrate, 35% fat and 20% protein diet) administered utilizing meal replacements. | Other | Insulin Resistant Study Subjects, Insulin Sensitive Study Participants |
| Low Fat DietLow fat diet (60% carbohydrate, 20% fat and 20% protein diet) administered utilizing meal replacements. | Other | Insulin Resistant Study Subjects, Insulin Sensitive Study Participants |
Primary outcome
Change in weight in kg
Time frame: 24 weeks
1 secondary outcome
Change in visceral fat via bioimpedance
Time frame: 24 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2010.
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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.
Raymond A Plodkowski, MD principal investigator
University of Nevada School of Medicine, Reno
Sachiko T St. Jeor, PhD, RD principal investigator
University of Nevada School of Medicine, Reno
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low Carbohydrate Diet and Low Fat Diet in people with Obesity and Insulin Resistance, run by University of Nevada, Las Vegas 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 3 inclusion and 16 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: status not confirmed, as of the sponsor's last update on 30 Apr 2010. 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.
Are results available for this study?
Results are not available in the source record.
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?
Change in weight in kg (time frame: 24 weeks). 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 30 Apr 2010.