ObesityNCT01757340
Calorie Restriction With Leucine Supplementation
A study testing Weight loss with normal protein and leucine intake and Weight loss with protein/leucine supplementation in people with Obesity and Menopause, run by Washington University School of Medicine at 1 site in United States.
Trial summary
The purpose of this study is to determine whether consuming additional leucine during calorie restriction induced weight loss has beneficial or harmful effects on multi-organ (liver, muscle, adipose tissue) insulin sensitivity, colonocyte proliferation rates, the gut microbiome, muscle mass and function, and bone… Read more about this study
- Who is it for?
- Ages 50 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Obesity, Menopause, Osteoporosis
- What is being tested?
- Weight loss with normal protein and leucine intake and Weight loss with protein/leucine supplementation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2012to Mar 2017
- 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 50 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Obese with body mass index (BMI) between 30 and 40 kg/m2
- Postmenopausal
- Sedentary (i.e., less than 1.5 hours of exercise per week)
Who cannot join
- Individuals with diabetes and/or uncontrolled hypertension
- Individuals with hepatitis B and/or C
- Individuals who smoke
- Individuals with an allergy to whey protein
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: Calorie Restriction With Leucine Supplementation in Postmenopausal Women
The purpose of this study is to determine whether consuming additional leucine during calorie restriction induced weight loss has beneficial or harmful effects on multi-organ (liver, muscle, adipose tissue) insulin sensitivity, colonocyte proliferation rates, the gut microbiome, muscle mass and function, and bone mineral density in obese, postmenopausal women.
- Conditions
- Obesity, Menopause, Osteoporosis, Sarcopenia
- Being tested
- Weight loss with normal protein and leucine intake, Weight loss with protein/leucine supplementation
- Medical subject headings
- Obesity, Osteoporosis, Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Weight loss with normal protein and leucine intakeBehavioural
Goal of 8 to 10% weight loss while consuming the recommended daily allowance of protein (i.e, 0.8 grams of protein per kg body weight per day).
Weight loss with protein/leucine supplementationBehavioural
Goal of 8 to 10% weight loss while consuming 150% of the recommended daily allowance of protein (i.e., 1.2 grams of protein per kg body weight per day) with the additional protein given in the form of whey protein, which has a high leucine content.
| Study group | Role | What they receive |
|---|---|---|
| Weight maintenance | No intervention | Weight maintenance with normal protein and leucine intake |
| Weight loss with normal protein intake | Active comparator | Not described Receives: Behavioral: Weight loss with normal protein and leucine intake |
| Weight loss with leucine supplementation | Experimental | Not described Receives: Behavioral: Weight loss with protein/leucine supplementation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in muscle mass
We will measure total appendicular skeletal muscle mass by using dual-energy X-ray absorptiometry (DXA) and thigh muscle volume by magnetic resonance imaging (MRI)
Measured: Baseline and at 10% weight loss in calorie restriction groups and ~6 to 7 months in the weight maintenance group
Change in muscle strength
We will evaluate muscle strength by administering maximum one repetition strength and isokinetic strength tests.
Measured: Baseline and at 10% weight loss in calorie restriction groups and ~6 to 7 months in the weight maintenance group
Change in bone mineral density and bone mineral content
We will evaluate total bone mass and total body and regional bone mineral density by using dual X-ray energy absorptiometry (DXA).
Measured: Baseline and at 10% weight loss in calorie restriction groups and ~6 to 7 months in the weight maintenance group
Secondary outcomes (5)
Change in skeletal muscle insulin sensitivity
We will evaluate insulin sensitivity using the hyperinsulinemic-euglycemic clamp procedure in conjunction with stable isotope labeled tracer infusions
Measured: Baseline and at 10% weight loss in calorie restriction groups and ~6 to 7 months in the weight maintenance group
Change in bacterial populations found in the stool
Measured: Baseline and at 10% weight loss in calorie restriction groups and ~6 to 7 months in the weight maintenance group
Change in cell proliferation (growth) rates in the colon
We will examine colon cell proliferation rates using stable isotope labelled tracer methods in conjunction with sigmoid colon biopsy samples
Measured: Baseline and at 10% weight loss in calorie restriction groups and ~6 to 7 months in the weight maintenance group
Determine the acute effect of leucine ingestion on skeletal muscle insulin sensitivity
We will evaluate insulin sensitivity using the hyperinsulinemic-euglycemic clamp procedure in conjunction with stable isotope labeled tracer infusions
Measured: Prior to starting the weight loss or maintenance intervention
Determine the acute effect of leucine ingestion on muscle protein metabolism
We will assess rates of muscle protein synthesis, breakdown and net protein balance using stable isotope labeled tracer methods during postabsorptive conditions and during insulin infusion with or without leucine ingestion.
Measured: Prior to starting the weight loss or maintenance intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2012 (estimated)
- Study startSep 2012
- Primary completionMar 2017
- Study completionMar 2017
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.
- 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
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Ajinomoto Co., Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01757340
- Sponsor's protocol ID
- CRL-201102153
- Status last verified
- Mar 2017
- First submitted
- 14 Dec 2012
- Last updated
- 27 Mar 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Smith GI, Yoshino J, Stromsdorfer KL, Klein SJ, Magkos F, Reeds DN, Klein S, Mittendorfer B. Protein Ingestion Induces Muscle Insulin Resistance Independent of Leucine-Mediated mTOR Activation. Diabetes. 2015 May;64(5):1555-63. doi: 10.2337/db14-1279. Epub 2014 Dec 4.
PubMed 25475435Harris LLS, Smith GI, Patterson BW, Ramaswamy RS, Okunade AL, Kelly SC, Porter LC, Klein S, Yoshino J, Mittendorfer B. Alterations in 3-Hydroxyisobutyrate and FGF21 Metabolism Are Associated With Protein Ingestion-Induced Insulin Resistance. Diabetes. 2017 Jul;66(7):1871-1878. doi: 10.2337/db16-1475. Epub 2017 May 4.
PubMed 28473464
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Calorie Restriction With Leucine Supplementation in Postmenopausal Women
- ClinicalTrials.gov ID
- NCT01757340
- Acronym / sponsor ID
- CRL-201102153
- Conditions
- Obesity, Menopause, Osteoporosis, Sarcopenia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- Ajinomoto Co., Inc.
- Study start
- Sep 2012 (actual)
- Primary completion
- Mar 2017 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 28 Dec 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.
The purpose of this study is to determine whether consuming additional leucine during calorie restriction induced weight loss has beneficial or harmful effects on multi-organ (liver, muscle, adipose tissue) insulin sensitivity, colonocyte proliferation rates, the gut microbiome, muscle mass and function, and bone mineral density in obese, postmenopausal women.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Weight maintenance | No intervention | –Weight maintenance with normal protein and leucine intake |
| Weight loss with normal protein intake | Active comparator | Behavioral: Weight loss with normal protein and leucine intake |
| Weight loss with leucine supplementation | Experimental | Behavioral: Weight loss with protein/leucine supplementation |
Who may qualify
- Ages
- 50 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Obese with body mass index (BMI) between 30 and 40 kg/m2
- Postmenopausal
- Sedentary (i.e., less than 1.5 hours of exercise per week)
Key exclusion criteria (4 listed)
- Individuals with diabetes and/or uncontrolled hypertension
- Individuals with hepatitis B and/or C
- Individuals who smoke
- Individuals with an allergy to whey protein
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 loss with normal protein and leucine intakeGoal of 8 to 10% weight loss while consuming the recommended daily allowance of protein (i.e, 0.8 grams of protein per kg body weight per day). | Behavioural | Weight loss with normal protein intake |
| Weight loss with protein/leucine supplementationGoal of 8 to 10% weight loss while consuming 150% of the recommended daily allowance of protein (i.e., 1.2 grams of protein per kg body weight per day) with the additional protein given in the form of whey protein, which has a high leucine content. | Behavioural | Weight loss with leucine supplementation |
Primary outcome
Change in muscle mass
Time frame: Baseline and at 10% weight loss in calorie restriction groups and ~6 to 7 months in the weight maintenance group
We will measure total appendicular skeletal muscle mass by using dual-energy X-ray absorptiometry (DXA) and thigh muscle volume by magnetic resonance imaging (MRI)
Change in muscle strength
Time frame: Baseline and at 10% weight loss in calorie restriction groups and ~6 to 7 months in the weight maintenance group
We will evaluate muscle strength by administering maximum one repetition strength and isokinetic strength tests.
Change in bone mineral density and bone mineral content
Time frame: Baseline and at 10% weight loss in calorie restriction groups and ~6 to 7 months in the weight maintenance group
We will evaluate total bone mass and total body and regional bone mineral density by using dual X-ray energy absorptiometry (DXA).
5 secondary outcomes
Change in skeletal muscle insulin sensitivity
Time frame: Baseline and at 10% weight loss in calorie restriction groups and ~6 to 7 months in the weight maintenance group
Change in bacterial populations found in the stool
Time frame: Baseline and at 10% weight loss in calorie restriction groups and ~6 to 7 months in the weight maintenance group
Change in cell proliferation (growth) rates in the colon
Time frame: Baseline and at 10% weight loss in calorie restriction groups and ~6 to 7 months in the weight maintenance group
Determine the acute effect of leucine ingestion on skeletal muscle insulin sensitivity
Time frame: Prior to starting the weight loss or maintenance intervention
Determine the acute effect of leucine ingestion on muscle protein metabolism
Time frame: Prior to starting the weight loss or maintenance 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 27 Mar 2017.
- Results publication: PubMed 25475435Smith GI, Yoshino J, Stromsdorfer KL, Klein SJ, Magkos F, Reeds DN, Klein S, Mittendorfer B. Protein Ingestion Induces Muscle Insulin Resistance Independent of Leucine-Mediated mTOR Activation. Diabetes. 2015 May;64(5):1555-63. doi: 10.2337/db14-1279. Epub 2014 Dec 4.
- Derived from this study: PubMed 28473464Harris LLS, Smith GI, Patterson BW, Ramaswamy RS, Okunade AL, Kelly SC, Porter LC, Klein S, Yoshino J, Mittendorfer B. Alterations in 3-Hydroxyisobutyrate and FGF21 Metabolism Are Associated With Protein Ingestion-Induced Insulin Resistance. Diabetes. 2017 Jul;66(7):1871-1878. doi: 10.2337/db16-1475. Epub 2017 May 4.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 loss with normal protein and leucine intake and Weight loss with protein/leucine supplementation in people with Obesity and Menopause, 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 4 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 27 Mar 2017. 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?
Change in muscle mass (time frame: Baseline and at 10% weight loss in calorie restriction groups and ~6 to 7 months in the weight maintenance group). The study lists 3 primary outcomes in all. 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 NCT01757340, 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 27 Mar 2017; AzTrials last refreshed its copy on 29 Oct 2026.