Nutritional Intervention for Age-related Muscular Function and Strength Losses-Study 2

NCT02043171 | Completed Phase 1 DMC

• 1 other identifier: MTI2014-CS01
• Study Type: interventional
• Target: 238
• Locations: 1 country
• Sites: 1

Brief Summary

Men and women lose muscle mass and strength with age. Loss of muscle mass and strength is accompanied by a loss of muscle function which can lead to diminished quality of life and more importantly can lead to serious fall requiring medical treatment. The investigators hypothesize that the combined supplements of Calcium-HMB and Vitamin D will lead to decreased falls and to improved quality of life (QOL) for older adults. The investigators further hypothesize that the addition of a modest exercise regimen to these supplements will enhance the synergistic effects of both Calcium-HMB and Vitamin D. Subjects will consume the dietary supplement 2 times per day for 12 months. Tests will consist of the following: a) strength of subjects' legs and elbow by Isokinetic Dynamometer; b) body composition; c) hand-grip strength by hand-grip dynamometer; d) functional mobility, balance and agility (Get-Up and Get-Up-and-Go tests); e) filling out questionnaires; and g) having blood drawn for biochemical measurements. Testing will be performed at the baseline (0 months) and at 3, 6, 9, and 12 months.

Conditions

Sarcopenia

Outcome Measures

Primary Outcomes (1)

• Muscular strength

  Leg and elbow strength will be tested by Isokinetic dynamometer and Handgrip strength will be tested using a hand-grip dynamometer.

  12 Months

Secondary Outcomes (1)

• Functionality

  12 months

Other Outcomes (2)

• Muscle mass

  12 months

• Quality of life

  12 months

Study Arms (4)

Placebo Exercise

PLACEBO COMPARATOR

Placebo supplementation group with 3 days per week of exercise

Dietary Supplement: Placebo; Behavioral: Exercise

Placebo Non-exercise

PLACEBO COMPARATOR

Placebo supplementation group without exercise

Dietary Supplement: Placebo; Behavioral: Non-Exercise

HMB plus Vitamin D Exercise

ACTIVE COMPARATOR

HMB plus Vitamin D supplementation group with 3 days per week of exercise

Drug: HMB plus Vitamin D; Behavioral: Exercise

HMB plus Vitamin D Non-exercise

ACTIVE COMPARATOR

HMB plus Vitamin D supplementation group without exercise

Drug: HMB plus Vitamin D; Behavioral: Non-Exercise

Interventions

Placebo DIETARY_SUPPLEMENT

A Placebo comparator

Placebo Exercise; Placebo Non-exercise

HMB plus Vitamin D DRUG

Active comparator of HMB (3 g/d) plus Vitamin D (2,000 IU/d)

Also known as: HMB (Calcium beta-hydroxy-beta-methylbutyrate), Vitamin D (Cholecalciferol)

HMB plus Vitamin D Exercise; HMB plus Vitamin D Non-exercise

Non-Exercise BEHAVIORAL

This group will not participate in 3 times per week strength training

HMB plus Vitamin D Non-exercise; Placebo Non-exercise

Exercise BEHAVIORAL

This group will participate in a supervised 3 times per week strength training program

HMB plus Vitamin D Exercise; Placebo Exercise

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and female subjects will be enrolled into the study.
• Age \> 60 years.
• Free of liver and kidney diseases, and with no evidence of uncontrolled hypertension.
• Does not have a chronic disease that affects calcium or bone metabolism (i.e., asthma with chronic use of high dose steroids, inflammatory bowel disease, Crohn's disease, primary hyperparathyroidism, seizure disorder with use of phenobarbital, etc.).
• Not classified as morbidly obese (body mass index (BMI) \>40 kg/m2).
• Six weeks since major surgery (three weeks since minor surgery).
• Willing to consume one of the nutritional supplements for the study period.
• Individuals diagnosed with osteoporosis, or bone density \> 2.0 standard deviations below the mean, will not be enrolled in the study.
• No other serious medical illness.
• Serum 25OH-vitD3 \>15 ng/ml.
• Willing to participate in 3-day-a-week monitored strength-training program.
• Physician has placed no restriction on physical exercise.

You may not qualify if:

• Age \< 60 years.
• Evidence of liver and kidney diseases, uncontrolled hypertension, or Type I diabetes mellitus requiring insulin for glucose control.
• Presence of a chronic disease that affects calcium or bone metabolism (i.e., asthma with chronic use of high dose steroids, inflammatory bowel disease, Crohn's disease, primary hyperparathyroidism, seizure disorder with use of phenobarbital, etc.).
• Classified as morbidly obese (body mass index (BMI) \>40 kg/m2).
• Less than six weeks since major surgery or three weeks since minor surgery.
• Not willing to consume one of the nutritional supplements for the study period.
• Individuals diagnosed with osteoporosis, or a bone density \> 2.0 standard deviations below the mean, will not be enrolled in the study.
• Other serious medical illness, which the subject's doctor or medical review team has decided affects the subject's ability to participate in the study.
• History of blood clots and/or the use of blood thinning medications
• Subjects on high dose vitamin D therapies (i.e. 50,000 IU vitamin D).
• Subjects with serum 25OH-vitD3 \<10 ng/ml will be considered deficient and will be referred to their physician for treatment.
• Subjects with serum 25OH-vitD3 \>30 ng/ml may not respond to the intervention as expected and will also be excluded from the study.
• Not able or willing to participate in 3-day-a-week monitored strength-training program.
• Physician has placed a restriction on physical exercise.

Sponsors & Collaborators

• Metabolic Technologies Inc.: lead
• Iowa State University: collaborator

Study Sites (1)

Iowa State University

Ames, Iowa, 50010, United States

Location

MeSH Terms

Conditions

Sarcopenia

Interventions

Vitamin D; Cholecalciferol; Exercise

Condition Hierarchy (Ancestors)

Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Secosteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Cholestenes; Cholestanes; Sterols; Membrane Lipids; Lipids; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• John A Rathmacher, PhD

  Metabolic Technologies Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 17, 2014
• First Posted: January 23, 2014
• Study Start: August 1, 2014
• Primary Completion: February 4, 2019
• Study Completion: February 4, 2019
• Last Updated: February 11, 2019

Record last verified: 2019-02

Locations

US (1)