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Calorie Restriction With Leucine Supplementation

Primary Purpose

Obesity, Menopause, Osteoporosis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Weight loss with normal protein and leucine intake
Weight loss with protein/leucine supplementation
Sponsored by
Washington University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity

Eligibility Criteria

50 Years - 65 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Washington University School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Active Comparator

Experimental

Arm Label

Weight maintenance

Weight loss with normal protein intake

Weight loss with leucine supplementation

Arm Description

Weight maintenance with normal protein and leucine intake

Outcomes

Primary Outcome Measures

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)
Change in muscle strength
We will evaluate muscle strength by administering maximum one repetition strength and isokinetic strength tests.
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).

Secondary Outcome Measures

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
Change in bacterial populations found in the stool
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
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
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.

Full Information

First Posted
December 14, 2012
Last Updated
March 24, 2017
Sponsor
Washington University School of Medicine
Collaborators
Ajinomoto Co., Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01757340
Brief Title
Calorie Restriction With Leucine Supplementation
Official Title
Calorie Restriction With Leucine Supplementation in Postmenopausal Women
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
September 2012 (Actual)
Primary Completion Date
March 2017 (Actual)
Study Completion Date
March 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Washington University School of Medicine
Collaborators
Ajinomoto Co., Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Menopause, Osteoporosis, Sarcopenia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
43 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Weight maintenance
Arm Type
No Intervention
Arm Description
Weight maintenance with normal protein and leucine intake
Arm Title
Weight loss with normal protein intake
Arm Type
Active Comparator
Arm Title
Weight loss with leucine supplementation
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Weight loss with normal protein and leucine intake
Intervention Description
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).
Intervention Type
Behavioral
Intervention Name(s)
Weight loss with protein/leucine supplementation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in muscle mass
Description
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)
Time Frame
Baseline and at 10% weight loss in calorie restriction groups and ~6 to 7 months in the weight maintenance group
Title
Change in muscle strength
Description
We will evaluate muscle strength by administering maximum one repetition strength and isokinetic strength tests.
Time Frame
Baseline and at 10% weight loss in calorie restriction groups and ~6 to 7 months in the weight maintenance group
Title
Change in bone mineral density and bone mineral content
Description
We will evaluate total bone mass and total body and regional bone mineral density by using dual X-ray energy absorptiometry (DXA).
Time Frame
Baseline and at 10% weight loss in calorie restriction groups and ~6 to 7 months in the weight maintenance group
Secondary Outcome Measure Information:
Title
Change in skeletal muscle insulin sensitivity
Description
We will evaluate insulin sensitivity using the hyperinsulinemic-euglycemic clamp procedure in conjunction with stable isotope labeled tracer infusions
Time Frame
Baseline and at 10% weight loss in calorie restriction groups and ~6 to 7 months in the weight maintenance group
Title
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
Title
Change in cell proliferation (growth) rates in the colon
Description
We will examine colon cell proliferation rates using stable isotope labelled tracer methods in conjunction with sigmoid colon biopsy samples
Time Frame
Baseline and at 10% weight loss in calorie restriction groups and ~6 to 7 months in the weight maintenance group
Title
Determine the acute effect of leucine ingestion on skeletal muscle insulin sensitivity
Description
We will evaluate insulin sensitivity using the hyperinsulinemic-euglycemic clamp procedure in conjunction with stable isotope labeled tracer infusions
Time Frame
Prior to starting the weight loss or maintenance intervention
Title
Determine the acute effect of leucine ingestion on muscle protein metabolism
Description
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.
Time Frame
Prior to starting the weight loss or maintenance intervention

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Facility Information:
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
25475435
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.
Results Reference
result
PubMed Identifier
28473464
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.
Results Reference
derived

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Calorie Restriction With Leucine Supplementation

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