Clinical trial NCT01757340: Calorie Restriction With Leucine Supplementation
Official title: Calorie Restriction With Leucine Supplementation in Postmenopausal Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Menopause
Osteoporosis
Sarcopenia
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: Ajinomoto Co., Inc.
First posted: 2012-12-28
Enrollment: 43
Sex: FEMALE
Minimum age (years): 50
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 mineral density in obese, postmenopausal women.


Eligibility criteria: Inclusion Criteria:

* 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)

Exclusion Criteria:

* Individuals with diabetes and/or uncontrolled hypertension
* Individuals with hepatitis B and/or C
* Individuals who smoke
* Individuals with an allergy to whey protein

Primary outcomes:
measure: Change in muscle mass
timeFrame: Baseline and at 10% weight loss in calorie restriction groups and ~6 to 7 months in the weight maintenance group
measure: Change in muscle strength
timeFrame: Baseline and at 10% weight loss in calorie restriction groups and ~6 to 7 months in the weight maintenance group
measure: Change in bone mineral density and bone mineral content
timeFrame: Baseline and at 10% weight loss in calorie restriction groups and ~6 to 7 months in the weight maintenance group
Secondary outcomes:
measure: Change in skeletal muscle insulin sensitivity
timeFrame: Baseline and at 10% weight loss in calorie restriction groups and ~6 to 7 months in the weight maintenance group
measure: Change in bacterial populations found in the stool
timeFrame: Baseline and at 10% weight loss in calorie restriction groups and ~6 to 7 months in the weight maintenance group
measure: Change in cell proliferation (growth) rates in the colon
timeFrame: Baseline and at 10% weight loss in calorie restriction groups and ~6 to 7 months in the weight maintenance group
measure: Determine the acute effect of leucine ingestion on skeletal muscle insulin sensitivity
timeFrame: Prior to starting the weight loss or maintenance intervention
measure: Determine the acute effect of leucine ingestion on muscle protein metabolism
timeFrame: Prior to starting the weight loss or maintenance intervention
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
Study officials:
References:
citation: 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.
citation: Harris 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.