Evaluate the Effect of Dietary Supplement on Muscle Mass and Physical Performance for Over 50 Years Old People

Orient Europharma

Status: Completed

Conditions: Muscle Loss

Treatments: Dietary Supplement: Dietary supplement; Dietary Supplement: vitamin B

Study type: Interventional

Funder types: Industry

Identifiers

NCT04229407

OEP-6CR003-401

Details and patient eligibility

About

To assess the ability and safety profile of dietary supplement to augment lean body mass, muscle strength, and physical performance among people aged 50 years and older

Full description

In light of the rapidly expanding aging population, sarcopenia and related disorders are emerging as a major public health problem of the 21st century.Sponsor has produced a dietary supplement, which has been on market in Taiwan. The proposed study is conducted to confirm whether the amino acid supplementation is able to enhance the magnitude of gain in lean body mass and muscle strength in middle-aged and older adults with muscle loss or sarcopenia undergoing exercise training.

Enrollment: 80 patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Main Inclusion Criteria:

1. Male or female aged 50 years or older.
2. Subjects who has muscle loss or at risk of muscle loss, with symptoms of reduced physical activities, reduced gait speed, exhaustion, or had tumbled/ fallen within past year
3. Willing to comply with study procedures and follow-ups
4. Provide written consent

Main Exclusion Criteria:

1. Gait speed ≤ 0.3 m/sec

2. Any disease that interferes with limb function, including:

   1. Limb fracture within past 6 months
   2. Severe knee, hip, or arm arthritis
   3. As judged by the investigator, disorder of nervous system (i.e., stroke, severe spinal stenosis, peripheral neuropathy, and Parkinson's disease) with poor control
   4. Intermittent claudication due to peripheral artery disease

3. As judged by the investigator, mental disorders (i.e., confirmed diagnosis of dementia) with poor control

4. Cardiopulmonary disease with poor control judged by the investigator

5. Malignancy with poor control judged by the investigator

6. Subjects claim to have chronic renal disease, defined as kidney damage or GFR < 30 mL/min/1.73 m2 for at least 3 months

7. Severe visual and hearing impairment that becomes barrier to communication

8. Subjects have taken any hormone replacement therapy within 3 months prior to study enrollment, or plans to begin hormone replacement therapy at any time during the study

9. Subjects with known poorly controlled diabetes (HbA1c > 9.0%), hyperthyroidism or thyroid insufficiency, Cushing's syndrome, or adrenal insufficiency

10. Subjects with known milk allergy or lactose intolerance

11. Other conditions that investigator considers subject is ineligible to participate in the study

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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80 participants in 2 patient groups, including a placebo group

Dietary supplement

Experimental group

Description:

subject will be evaluated for the eligibility of MRI assessment to assign subjects in randomization strata (MRI or non-MRI). After 32 subjects in MRI strata is reached. subjects will be randomized to intake Dietary supplement twice daily (every morning and night, 30 minutes after exercise if do exercise) for 12 weeks

Treatment:

Dietary Supplement: Dietary supplement

vitamin B

Placebo Comparator group

Description:

subject will be evaluated for the eligibility of MRI assessment to assign subjects in randomization strata (MRI or non-MRI). After 32 subjects in MRI strata is reached. subjects will be randomized to intake placebo vitamin B twice daily (every morning and night, 30 minutes after exercise if do exercise) for 12 weeks.

Treatment:

Dietary Supplement: vitamin B