Calorie Restriction With Leucine Supplementation

NCT01757340 | Completed DMC

• 1 other identifier: CRL-201102153
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity; Menopause; Osteoporosis; Sarcopenia

Outcome Measures

Primary Outcomes (3)

• 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)

  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.

  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).

  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

  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

  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

  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

  Prior to starting the weight loss or maintenance intervention

• Determine the acute effect of leucine ingestion on muscle protein metabolism

  Prior to starting the weight loss or maintenance intervention

Study Arms (3)

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

Interventions

Weight loss with normal protein and leucine intake BEHAVIORAL

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 normal protein intake

Weight loss with protein/leucine supplementation BEHAVIORAL

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.

Weight loss with leucine supplementation

Eligibility Criteria

• Age: 50 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

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

Sponsors & Collaborators

• Washington University School of Medicine: lead
• Ajinomoto Co., Inc.: collaborator

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Related Publications (2)

• 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.

  PMID: 25475435 RESULT

• 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.

  PMID: 28473464 DERIVED

MeSH Terms

Conditions

Obesity; Osteoporosis; Sarcopenia

Interventions

Proteins

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical

Intervention Hierarchy (Ancestors)

Amino Acids, Peptides, and Proteins

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 14, 2012
• First Posted: December 28, 2012
• Study Start: September 1, 2012
• Primary Completion: March 1, 2017
• Study Completion: March 1, 2017
• Last Updated: March 27, 2017

Record last verified: 2017-03

Locations

US (1)