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

NCT04229407 | Completed

• 1 other identifier: OEP-6CR003-401
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Muscle Loss

Outcome Measures

Primary Outcomes (3)

• The proportion of subjects achieving clinically meaningful improvement in Increment ≥ 3% in bone-free lean body mass (unit: kilogram) at 12 weeks after baseline

  Bone-free lean body mass will be assessed by measured by dual- energy X-ray absorptiometry. An increment of ≥ 3% from baseline after 12 weeks of intervention will be regarded as clinically meaningful improvement.

  12 weeks

• The proportion of subjects achieving clinically meaningful improvement in Increment ≥ 3% in 30-sec chair stand test (unit: number of stand) at 12 weeks after baseline

  The score is the total number of stands within 30 seconds.

  12 weeks

• The proportion of subjects achieving clinically meaningful improvement in Increment ≥ 3% in strength of hand grip (unit: kilogram) at 12 weeks after baseline

  Strength of hand grip will be assessed by Smedlay's DynamoMeter TTM Tokyo Japan. An increment of ≥ 3% from baseline after 12 weeks of intervention will be regarded as clinically meaningful improvement.

  12 weeks

Secondary Outcomes (7)

• Mean change in bone-free lean body mass at 4 and 12 weeks after baseline

  12 weeks

• Mean change in 30-sec chair stand test at 4 and 12 weeks after baseline

  12 weeks

• Mean change in 6-meter walk test at 4 and 12 weeks after baseline

  12 weeks

• Mean change in short physical performance battery (SPPB) score at 4 and 12 weeks after baseline

  12 weeks

• Mean change in strength of hand grip at 4 and 12 weeks after baseline

  12 weeks

Study Arms (2)

Dietary supplement

EXPERIMENTAL

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

Dietary Supplement: Dietary supplement

vitamin B

PLACEBO COMPARATOR

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.

Dietary Supplement: vitamin B

Interventions

Dietary supplement DIETARY_SUPPLEMENT

MRI eligibility evaluation Dietary supplement drink powder dissolved in 150 c.c. warm water oral intake twice daily at every morning and night (30 minutes after exercise if do exercise) for 12 weeks subjects will be instructed to do 45-minute exercise once a week following the training program of the study trainer at gym, and 30-minute exercise (per exercise manual) at least twice a week at home.

Dietary supplement

vitamin B DIETARY_SUPPLEMENT

MRI eligibility evaluation vitamin B drink powder dissolved in 150 c.c. warm water oral intake twice daily at every morning and night (30 minutes after exercise if do exercise)for 12 weeks subjects will be instructed to do 45-minute exercise once a week following the training program of the study trainer at gym, and 30-minute exercise (per exercise manual) at least twice a week at home.

vitamin B

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female aged 50 years or older.
• 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
• Willing to comply with study procedures and follow-ups
• Provide written consent

You may not qualify if:

• Gait speed ≤ 0.3 m/sec
• Any disease that interferes with limb function, including:
• Limb fracture within past 6 months
• Severe knee, hip, or arm arthritis
• As judged by the investigator, disorder of nervous system (i.e., stroke, severe spinal stenosis, peripheral neuropathy, and Parkinson's disease) with poor control
• Intermittent claudication due to peripheral artery disease
• As judged by the investigator, mental disorders (i.e., confirmed diagnosis of dementia) with poor control
• Cardiopulmonary disease with poor control judged by the investigator
• Malignancy with poor control judged by the investigator
• Subjects claim to have chronic renal disease, defined as kidney damage or GFR \< 30 mL/min/1.73 m2 for at least 3 months
• Severe visual and hearing impairment that becomes barrier to communication
• 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
• Subjects with known poorly controlled diabetes (HbA1c \> 9.0%), hyperthyroidism or thyroid insufficiency, Cushing's syndrome, or adrenal insufficiency
• Subjects with known milk allergy or lactose intolerance
• Other conditions that investigator considers subject is ineligible to participate in the study

Sponsors & Collaborators

• Orient Europharma Co., Ltd.: lead

Study Sites (1)

Veteran General Hospital-Taipei

Taipei, 112, Taiwan

Location

MeSH Terms

Conditions

Muscular Atrophy

Interventions

Dietary Supplements; Folic Acid

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Liang-Kung Chen, MD.PhD

  Taipei Veterans General Hospital, Taiwan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: double blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 10, 2018
• First Posted: January 18, 2020
• Study Start: March 12, 2018
• Primary Completion: October 7, 2020
• Study Completion: October 7, 2020
• Last Updated: April 30, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)