ObesityNCT01642849
Effect of Diet Composition on Weight Change and Metabolic Parameters
A study testing high protein diet and high carbohydrate diet in people with Obesity and Inflammation, run by University of Tennessee at 1 site in United States.
Trial summary
This study will assess the effect of high protein (HP) and high carbohydrate (HC) diets on weight loss and other metabolic parameters. Rationale: The prevalence of obesity is on the rise in the US. The health hazards of obesity have been well established. Read more about this study
- Who is it for?
- Ages 20 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Obesity, Inflammation
- What is being tested?
- high protein diet and high carbohydrate diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2009to Jun 2013
- 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 20 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age range 20 yrs to 50 yrs,
- BMI > 30 kg/m2 to < 55 kg/m2
- Fasting glucose < 110 mg/dl and 120 minute OGTT < 170 mg/dl glucose
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Abbas E Kitabchi, M.D. contact
United States1 site, 1 recruiting
- Recruiting
University of Tennessee Health Science Center
Memphis, Tennessee, 38163
Frankie B Stentz, M.S., Ph.D., 901-448-5803, fstentz@uthsc.edu
Abbas E Kitabchi, M.D.
About this study
This study will assess the effect of high protein (HP) and high carbohydrate (HC) diets on weight loss and other metabolic parameters.
Rationale: The prevalence of obesity is on the rise in the US. The health hazards of obesity have been well established. The detrimental effects of obesity on cardiovascular, metabolic and psychological parameters as well as the excess cost to the national health budget are astounding. One way of treatment and prevention of obesity has been the use of diet and exercise. In the absence of well-established superiority of one diet over another, different scientifically unproven diets are in common use. A palatable diet providing satiety as well as all essential nutrients may go a long way in treating over-weight individuals. Another factor has been the long-term adherence to such weight loss regimens, which in general have been poor. Protein diets have been known to provide greater satiety and reduced energy intake than carbohydrate diets, but definite long-term studies are sparse. For this study the investigators will recruit and study 24 normal, pre-menopausal obese women (12 on HP diet and 12 on HC diet), and compare their weight loss and changes in metabolic parameters between the two diets.
Read the detailed description
Population: Recruit and study 24 pre-menopausal women with the following inclusion criteria:
Age range 20 yrs to 50 yrs, BMI > 30 kg/m2 to < 55 kg/m2 Fasting glucose < 110 mg/dl and 120 minute OGTT < 170 mg/dl glucose Design: The study is designed to determine the follow
To compare the effects of high protein (HP) versus high carbohydrate (HC) diet during energy restriction on weight loss, body composition (lean and fat body mass) and bone mineral density in a free living out patient setting.
To assess the effects of HP versus HC diets on metabolic parameters including insulin sensitivity, protein and muscle break down, lipoprotein metabolism and basal metabolic rate.
Procedures: SCREENING VISIT 1:Individuals fulfilling the inclusion and exclusion criteria will be invited for the first screening visit (VS1). A brief study overview will be given along with a brief history and physical examination, height and weight measurements and blood drawn for chemistry profile and and Oral Glucose Tolerance Test (OGTT) to determine normal glucose handling.
SCREENING VISIT 2 (VS2):Individuals fulfilling all the criteria will be contacted and invited for a second screening visit (VS2). Block food frequency questionnaire to assess baseline dietary profile will be given along with a pre-study orientation with the help of a nutritionist.
SCREENING VISIT 3 (VS3): At the final screening visit (VS3) the food diary will be reviewed. Individuals will be randomized into one of the two diet groups using a randomization table. Participants will be asked to participate in the additional studies of euglycemic hyperinsulinemic clamp and indirect calorimetry.
Study participants will either follow a HP or a HC diet for 6 months, where all food is supplied to them. Randomization will be performed using a randomization table. HP diet will be based on 30% Kcals from protein, 40% Kcals from carbohydrate (CHO) and 30% Kcals from fat. In contrast, HC diet will comprise 15% Kcals from protein, 55% Kcals from CHO and 30% Kcals from fat. Subjects will come in weekly for their food pick up and weight checks.
- Conditions
- Obesity, Inflammation
- Being tested
- high protein diet, high carbohydrate diet
- Keywords
- high protein diet, high carbohydrate diet, weight loss, oxidative stress, inflammation, cardiovascular risk factors
- Medical subject headings
- Obesity, Inflammation, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
high protein dietDietary supplement
6 months on HP diet
high carbohydrate dietDietary supplement
12 subjects will be placed on a hig carbohydrate diet for 6 months
| Study group | Role | What they receive |
|---|---|---|
| high protein diet | Experimental | 12 subjects will be place on a high protein diet Receives: Dietary Supplement: high protein diet; Dietary Supplement: high carbohydrate diet |
| high carbohydrate diet | Experimental | 12 subjects will be put on a high carbohydrate diet for 6 months Receives: Dietary Supplement: high carbohydrate diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of Diet Composition on Weight Change and Metabolic Parameters
Outcome Measures: The effect of a high protein diet or a high carbohydrate diet provided to subjects for 6 months on metabolic parameters.
Measured: 6 months on High Protein or High Carbohydrate diet
Secondary outcomes (1)
Effect of Diet Composition on Weight Change and Metabolic Parameters
The effect of a high protein or high carbohydrate diet supplied to subjects for 6 months on weight loss.
Measured: 6 months on a high protein or high carbohydrate diet
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2012 (estimated)
- Study startJan 2009
- Primary completionJan 2013 (estimated)
- Study completionJun 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Tennessee
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Frankie B. Stentz, M.S., Ph.D., Principal investigator, University of Tennessee
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01642849
- Sponsor's protocol ID
- 03-07996-FB
- Other IDs
- 1-09-CR-32
- Status last verified
- Jul 2012
- First submitted
- 3 Jul 2012
- Last updated
- 17 Jul 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Stentz FB, Lawson D, Tucker S, Christman J, Sands C. Decreased cardiovascular risk factors and inflammation with remission of type 2 diabetes in adults with obesity using a high protein diet: Randomized control trial. Obes Pillars. 2022 Dec 1;4:100047. doi: 10.1016/j.obpill.2022.100047. eCollection 2022 Dec.
PubMed 37990670Stentz FB, Mikhael A, Kineish O, Christman J, Sands C. High protein diet leads to prediabetes remission and positive changes in incretins and cardiovascular risk factors. Nutr Metab Cardiovasc Dis. 2021 Apr 9;31(4):1227-1237. doi: 10.1016/j.numecd.2020.11.027. Epub 2020 Dec 8.
PubMed 33549435
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Diet Composition on Weight Change and Metabolic Parameters
- ClinicalTrials.gov ID
- NCT01642849
- Acronym / sponsor ID
- 03-07996-FB
- Conditions
- Obesity, Inflammation
- Keywords
- high protein diet, high carbohydrate diet, weight loss, oxidative stress, inflammation, cardiovascular risk factors
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- University of TennesseeUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- Jan 2013 (estimated)
- Study completion
- Jun 2013 (estimated)
- First posted
- 17 Jul 2012 (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 assess the effect of high protein (HP) and high carbohydrate (HC) diets on weight loss and other metabolic parameters.
Rationale: The prevalence of obesity is on the rise in the US. The health hazards of obesity have been well established. The detrimental effects of obesity on cardiovascular, metabolic and psychological parameters as well as the excess cost to the national health budget are astounding. One way of treatment and prevention of obesity has been the use of diet and exercise. In the absence of well-established superiority of one diet over another, different scientifically unproven diets are in common use. A palatable diet providing satiety as well as all essential nutrients may go a long way in treating over-weight individuals. Another factor has been the long-term adherence to such weight loss regimens, which in general have been poor. Protein diets have been known to provide greater satiety and reduced energy intake than carbohydrate diets, but definite long-term studies are sparse. For this study the investigators will recruit and study 24 normal, pre-menopausal obese women (12 on HP diet and 12 on HC diet), and compare their weight loss and changes in metabolic parameters between the two diets.
Detailed description
Population: Recruit and study 24 pre-menopausal women with the following inclusion criteria:
Age range 20 yrs to 50 yrs, BMI > 30 kg/m2 to < 55 kg/m2 Fasting glucose < 110 mg/dl and 120 minute OGTT < 170 mg/dl glucose Design: The study is designed to determine the follow
To compare the effects of high protein (HP) versus high carbohydrate (HC) diet during energy restriction on weight loss, body composition (lean and fat body mass) and bone mineral density in a free living out patient setting.
To assess the effects of HP versus HC diets on metabolic parameters including insulin sensitivity, protein and muscle break down, lipoprotein metabolism and basal metabolic rate.
Procedures: SCREENING VISIT 1:Individuals fulfilling the inclusion and exclusion criteria will be invited for the first screening visit (VS1). A brief study overview will be given along with a brief history and physical examination, height and weight measurements and blood drawn for chemistry profile and and Oral Glucose Tolerance Test (OGTT) to determine normal glucose handling.
SCREENING VISIT 2 (VS2):Individuals fulfilling all the criteria will be contacted and invited for a second screening visit (VS2). Block food frequency questionnaire to assess baseline dietary profile will be given along with a pre-study orientation with the help of a nutritionist.
SCREENING VISIT 3 (VS3): At the final screening visit (VS3) the food diary will be reviewed. Individuals will be randomized into one of the two diet groups using a randomization table. Participants will be asked to participate in the additional studies of euglycemic hyperinsulinemic clamp and indirect calorimetry.
Study participants will either follow a HP or a HC diet for 6 months, where all food is supplied to them. Randomization will be performed using a randomization table. HP diet will be based on 30% Kcals from protein, 40% Kcals from carbohydrate (CHO) and 30% Kcals from fat. In contrast, HC diet will comprise 15% Kcals from protein, 55% Kcals from CHO and 30% Kcals from fat. Subjects will come in weekly for their food pick up and weight checks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| high protein diet | Experimental | Dietary Supplement: high protein diet, Dietary Supplement: high carbohydrate diet12 subjects will be place on a high protein diet |
| high carbohydrate diet | Experimental | Dietary Supplement: high carbohydrate diet12 subjects will be put on a high carbohydrate diet for 6 months |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Age range 20 yrs to 50 yrs,
- BMI > 30 kg/m2 to < 55 kg/m2
- Fasting glucose < 110 mg/dl and 120 minute OGTT < 170 mg/dl glucose
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| high protein diet6 months on HP diet | Dietary supplement | high protein diet |
| high carbohydrate diet12 subjects will be placed on a hig carbohydrate diet for 6 months | Dietary supplement | high carbohydrate diet, high protein diet |
Primary outcome
Effect of Diet Composition on Weight Change and Metabolic Parameters
Time frame: 6 months on High Protein or High Carbohydrate diet
Outcome Measures: The effect of a high protein diet or a high carbohydrate diet provided to subjects for 6 months on metabolic parameters.
1 secondary outcome
Effect of Diet Composition on Weight Change and Metabolic Parameters
Time frame: 6 months on a high protein or high carbohydrate diet
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2012.
- Derived from this study: PubMed 37990670Stentz FB, Lawson D, Tucker S, Christman J, Sands C. Decreased cardiovascular risk factors and inflammation with remission of type 2 diabetes in adults with obesity using a high protein diet: Randomized control trial. Obes Pillars. 2022 Dec 1;4:100047. doi: 10.1016/j.obpill.2022.100047. eCollection 2022 Dec.
- Derived from this study: PubMed 33549435Stentz FB, Mikhael A, Kineish O, Christman J, Sands C. High protein diet leads to prediabetes remission and positive changes in incretins and cardiovascular risk factors. Nutr Metab Cardiovasc Dis. 2021 Apr 9;31(4):1227-1237. doi: 10.1016/j.numecd.2020.11.027. Epub 2020 Dec 8.
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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.
Abbas E Kitabchi, M.D. contact
Frankie B. Stentz, M.S., Ph.D. principal investigator
University of Tennessee
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing high protein diet and high carbohydrate diet in people with Obesity and Inflammation, run by University of Tennessee 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 0 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 17 Jul 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.
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?
Contact Frankie B Stentz, M.S., Ph.D. (901-448-5803, fstentz@uthsc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect of Diet Composition on Weight Change and Metabolic Parameters (time frame: 6 months on High Protein or High Carbohydrate diet). 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 NCT01642849, which also lists 2 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 17 Jul 2012.