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NCT02043171 · ClinicalTrials.gov registry record · Phase 1
Nutritional Intervention for Age-related Muscular Function and Strength Losses-Study 2
A Phase 1 study, sponsored by Metabolic Technologies.
- Completed
- Registry status
- Phase 1
- Development phase
- 238
- Enrollment target
NCT02043171: Completed Phase 1 study, sponsored by Metabolic Technologies.
NCT02043171 is a Phase 1 study that has completed, run by Metabolic Technologies. The registered enrollment target is 238 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (297% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02043171, a Phase 1 study, has completed, sponsored by Metabolic Technologies.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 238 participants
- Enrollment target
Study 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.
Primary Outcome
Leg and elbow strength will be tested by Isokinetic dynamometer and Handgrip strength will be tested using a hand-grip dynamometer.
Interventions
- DIETARY_SUPPLEMENT Placebo
- BEHAVIORAL Exercise
- DRUG HMB plus Vitamin D
- BEHAVIORAL Non-Exercise
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 238 participants |
| Start Date | 2014-08 |
| Est. Completion | 2019-02-04 |
| Phase | Phase 1 |
What the finished NCT02043171 record still lists
NCT02043171 is an interventional study that assigns participants to a tested intervention. The registered 238 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (297% higher).
The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.
NCT02043171 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02043171 about?
NCT02043171 is a clinical study titled "Nutritional Intervention for Age-related Muscular Function and Strength Losses-Study 2". 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 s...
What is the current status of trial NCT02043171?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 238 participants. The study started on 2014-08. Estimated completion is 2019-02-04.
What interventions are being tested in trial NCT02043171?
The interventions under investigation include: Placebo (DIETARY_SUPPLEMENT), Exercise (BEHAVIORAL), HMB plus Vitamin D (DRUG), Non-Exercise (BEHAVIORAL).
Who is sponsoring clinical trial NCT02043171?
This trial is sponsored by Metabolic Technologies, which has 16 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02043171's enrollment target sits among peer trials
238 212th of 2000 higher than 1,789 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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