ObesityNCT02004002
Protein Intake & Insulin Action
A study testing Weight maintenance with normal protein intake and Weight maintenance with protein restriction in people with Obesity, run by Washington University School of Medicine at 1 site in United States.
Trial summary
The purpose of this proposal is to determine whether dietary protein restriction has beneficial effects on skeletal muscle insulin sensitivity and β-cell function in obese men and women. 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?
- Weight maintenance with normal protein intake and Weight maintenance with protein restriction
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2013to Sep 2016
- 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
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Body mass index (BMI) between 30 and 50 kg/m2
- Subjects who are sedentary (<1.5 h of exercise/week)
- Subjects with a high habitual protein intake (>1.2 g/kg body mass/day)
Who cannot join
- Subjects with evidence of significant organ system dysfunction (e.g. diabetes, severe cardiovascular disease, hyperlipidemia, cirrhosis, hypogonadism, uncontrolled hypo- or hyperthyroidism; uncontrolled hypertension)
- Subjects with metal implants
- Individuals with cancer or cancer that has been in remission for <5 years,
- Individuals with dementia,
- Individuals who use tobacco products,
- Subjects who are taking medications known to affect glucose metabolism (e.g., steroids),
- Subjects taking medications to control certain medical conditions (e.g., hypertension) will be included if the drug regimen has been stable for at least 6 months before entering the study and is not expected to change during the study.
- Women who are pregnant due to changes in body composition and decreases in insulin sensitivity caused by pregnancy
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University School of Medicine
St Louis, Missouri, 63110
About this study
Official title: Dietary Protein Intake, Insulin Sensitivity and β-cell Function
The purpose of this proposal is to determine whether dietary protein restriction has beneficial effects on skeletal muscle insulin sensitivity and β-cell function in obese men and women.
Read the detailed description
Insulin resistance, impaired pancreatic β-cell function, and diabetes are important complications associated with obesity. Although excess energy intake and body fat accumulation are considered the major culprits responsible for obesity-associated metabolic abnormalities, it is possible that insulin resistance and impaired β-cell function are also due to increased dietary protein intake.
Protein intake is ~15 to 25% greater in obese than lean adults and exceeds the current Institute of Medicine Recommended Daily Allowance (RDA) of 0.8 g protein/kg body weight by ~75%. An increase in habitual protein intake of only 10 to 40%, assessed using dietary recall methods, been shown to increase the risk of developing diabetes by up to 2.2 fold. Additionally, the ability to stimulate glucose disposal during insulin infusion is reported to be impaired in individuals consuming double the recommended protein intake as part of an isoenergetic diet. However, it is not known whether decreasing protein intake can improve insulin sensitivity and β-cell function in weight-stable, obese individuals.
Accordingly, obese men and women will be randomized to 8 weeks of treatment with a weight maintaining diet containing either i) 0.8 g protein/kg body weight (as recommended by the Institute of Medicine; protein restriction group)or ii) 1.4 g protein/kg body weight (control group). All subjects will receive a standardized "base-diet" with or without protein supplementation to avoid potential food selection bias that could confound the results when using high- and low-protein diets.
- Conditions
- Obesity
- Being tested
- Weight maintenance with normal protein intake, Weight maintenance with protein restriction
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Weight maintenance with normal protein intakeBehavioural
Control group will consume 1.4 g/kg/d of protein; consistent with the average protein intake in the US population.
Weight maintenance with protein restrictionBehavioural
Protein restriction group will receive the Institute of Medicine RDA of 0.8 g protein/kg body wt/d.
| Study group | Role | What they receive |
|---|---|---|
| Weight maintenance with normal protein intake | Active comparator | Control group will consume 1.4 g protein/kg body wt/d; consistent with the average protein intake in the US population. Receives: Behavioral: Weight maintenance with normal protein intake |
| Weight maintenance with protein restriction | Experimental | Protein restriction group will receive the Institute of Medicine RDA of 0.8 g protein/kg body wt/d. Receives: Behavioral: Weight maintenance with protein restriction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insulin sensitivity
We will evaluate insulin sensitivity using the hyperinsulinemic-euglycemic clamp procedure in conjunction with stable isotope labeled tracer infusions.
Measured: up to 8 wk dietary intervention
total β-cell sensitivity index (Φtotal)
The total β-cell sensitivity index assesses the insulin secretion response to changes in plasma glucose concentration following ingestion of a glucose drink.
Measured: Before and after the 8 wk dietary intervention
Secondary outcomes (1)
Disposition index
The disposition index provides an assessment of insulin secretion in relationship to insulin sensitivity to determine whether insulin secretion was "appropriate" for the degree of insulin sensitivity.
Measured: Before and after the 8 wk dietary intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2013 (estimated)
- Study startDec 2013
- Primary completionJul 2016
- Study completionSep 2016
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 Washington University School of MedicineThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gordon Smith, PhD, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02004002
- Sponsor's protocol ID
- WSP-201303080
- Status last verified
- Oct 2016
- First submitted
- 2 Dec 2013
- Last updated
- 12 Oct 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dietary Protein Intake, Insulin Sensitivity and β-cell Function
- ClinicalTrials.gov ID
- NCT02004002
- Acronym / sponsor ID
- WSP-201303080
- Conditions
- Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- Dec 2013
- Primary completion
- Jul 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 6 Dec 2013 (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 proposal is to determine whether dietary protein restriction has beneficial effects on skeletal muscle insulin sensitivity and β-cell function in obese men and women.
Detailed description
Insulin resistance, impaired pancreatic β-cell function, and diabetes are important complications associated with obesity. Although excess energy intake and body fat accumulation are considered the major culprits responsible for obesity-associated metabolic abnormalities, it is possible that insulin resistance and impaired β-cell function are also due to increased dietary protein intake.
Protein intake is ~15 to 25% greater in obese than lean adults and exceeds the current Institute of Medicine Recommended Daily Allowance (RDA) of 0.8 g protein/kg body weight by ~75%. An increase in habitual protein intake of only 10 to 40%, assessed using dietary recall methods, been shown to increase the risk of developing diabetes by up to 2.2 fold. Additionally, the ability to stimulate glucose disposal during insulin infusion is reported to be impaired in individuals consuming double the recommended protein intake as part of an isoenergetic diet. However, it is not known whether decreasing protein intake can improve insulin sensitivity and β-cell function in weight-stable, obese individuals.
Accordingly, obese men and women will be randomized to 8 weeks of treatment with a weight maintaining diet containing either i) 0.8 g protein/kg body weight (as recommended by the Institute of Medicine; protein restriction group)or ii) 1.4 g protein/kg body weight (control group). All subjects will receive a standardized "base-diet" with or without protein supplementation to avoid potential food selection bias that could confound the results when using high- and low-protein diets.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Weight maintenance with normal protein intake | Active comparator | Behavioral: Weight maintenance with normal protein intakeControl group will consume 1.4 g protein/kg body wt/d; consistent with the average protein intake in the US population. |
| Weight maintenance with protein restriction | Experimental | Behavioral: Weight maintenance with protein restrictionProtein restriction group will receive the Institute of Medicine RDA of 0.8 g protein/kg body wt/d. |
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 (BMI) between 30 and 50 kg/m2
- Subjects who are sedentary (<1.5 h of exercise/week)
- Subjects with a high habitual protein intake (>1.2 g/kg body mass/day)
Key exclusion criteria (8 listed)
- Subjects with evidence of significant organ system dysfunction (e.g. diabetes, severe cardiovascular disease, hyperlipidemia, cirrhosis, hypogonadism, uncontrolled hypo- or hyperthyroidism; uncontrolled hypertension)
- Subjects with metal implants
- Individuals with cancer or cancer that has been in remission for <5 years,
- Individuals with dementia,
- Individuals who use tobacco products,
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 |
|---|---|---|
| Weight maintenance with normal protein intakeControl group will consume 1.4 g/kg/d of protein; consistent with the average protein intake in the US population. | Behavioural | Weight maintenance with normal protein intake |
| Weight maintenance with protein restrictionProtein restriction group will receive the Institute of Medicine RDA of 0.8 g protein/kg body wt/d. | Behavioural | Weight maintenance with protein restriction |
Primary outcome
Insulin sensitivity
Time frame: up to 8 wk dietary intervention
We will evaluate insulin sensitivity using the hyperinsulinemic-euglycemic clamp procedure in conjunction with stable isotope labeled tracer infusions.
total β-cell sensitivity index (Φtotal)
Time frame: Before and after the 8 wk dietary intervention
The total β-cell sensitivity index assesses the insulin secretion response to changes in plasma glucose concentration following ingestion of a glucose drink.
1 secondary outcome
Disposition index
Time frame: Before and after the 8 wk dietary intervention
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 12 Oct 2016.
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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.
Gordon Smith, PhD principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Weight maintenance with normal protein intake and Weight maintenance with protein restriction in people with Obesity, run by Washington University School of Medicine 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 8 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 12 Oct 2016. 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?
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?
Insulin sensitivity (time frame: up to 8 wk dietary intervention). The study lists 2 primary outcomes in all. 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 12 Oct 2016.