NCT03891134

Brief Summary

Sarcopenia is an age-related poor healthy outcome. nutrition intervention is one , progressive, generalized loss of muscle mass and the decrement in physical activity. Sarcopenia is associated with subsequent health hazards such as disability, falls, functional degeneration, hospitalization and death. There are similar causes between sarcopenia and constipation such as aging, reduced mobility, changes in diet and co-morbidities. Nutrition plays an important role for muscle maintenance. The trial tries to figure out the effect of enriched branched-chain amino acid (BCAA) nutrient on muscle mass, strength and physical performance of sarcopenia in the middle-aged and old people.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
630

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2016

Shorter than P25 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 12, 2016

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 6, 2017

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 8, 2017

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

March 3, 2019

Completed
23 days until next milestone

First Posted

Study publicly available on registry

March 26, 2019

Completed
Last Updated

March 26, 2019

Status Verified

May 1, 2016

Enrollment Period

2 months

First QC Date

March 3, 2019

Last Update Submit

March 25, 2019

Conditions

Sarcopenia

Outcome Measures

Primary Outcomes (9)

  • Skeletal muscle mass index

    Skeletal muscle mass index was measured by bioelectrical impedance analysis (BC-418, Tanita)

    0 week

  • Skeletal muscle mass index

    Skeletal muscle mass index was measured by bioelectrical impedance analysis (BC-418, Tanita)

    5 weeks

  • Skeletal muscle mass index

    Skeletal muscle mass index was measured by bioelectrical impedance analysis (BC-418, Tanita)

    17 weeks

  • Handgrip

    Grip strength was measured by Grip-D; TKK 5401

    0 weeks

  • Handgrip

    Grip strength was measured by Grip-D; TKK 5401

    5 weeks

  • Handgrip

    Grip strength was measured by Grip-D; TKK 5401

    17 weeks

  • 6-meter gait speed

    Measure walking speed of six meters

    0 weeks

  • 6-meter gait speed

    Measure walking speed of six meters

    5 weeks

  • 6-meter gait speed

    Measure walking speed of six meters

    17 weeks

Study Arms (1)

enriched Branched Chain Amino Acid intervention

EXPERIMENTAL

enriched Branched Chain Amino Acid nutrition supplement 3.6 g twice a day for 5 weeks then withdrawal nutrition supplement for 12 weeks

Dietary Supplement: Branched Chain Amino Acid

Interventions

Branched Chain Amino AcidDIETARY_SUPPLEMENT

Participants were purposively sampled to receive one sachet enriched BCAA twice a day(7.2g) for 5 weeks.

enriched Branched Chain Amino Acid intervention

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • over 40 years of age
  • generally healthy according to responses to a standard health-screening questionnaire.

You may not qualify if:

  • uncontrolled hypertension or diabetes
  • stroke
  • severe liver or renal disease
  • gastrointestinal disease
  • neuromuscular disease
  • infectious disease
  • cancer,
  • pulmonary disease
  • disease of the endocrine system
  • history of seizures, neurological or significant psychiatric illness
  • sensitivity to study ingredients.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Janssen I, Heymsfield SB, Ross R. Low relative skeletal muscle mass (sarcopenia) in older persons is associated with functional impairment and physical disability. J Am Geriatr Soc. 2002 May;50(5):889-96. doi: 10.1046/j.1532-5415.2002.50216.x.

    PMID: 12028177RESULT

MeSH Terms

Conditions

Sarcopenia

Interventions

Amino Acids, Branched-Chain

Condition Hierarchy (Ancestors)

Muscular AtrophyNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesAtrophyPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsSigns and Symptoms

Intervention Hierarchy (Ancestors)

Amino AcidsAmino Acids, Peptides, and Proteins

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: quasi-experimental design
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 3, 2019

First Posted

March 26, 2019

Study Start

December 12, 2016

Primary Completion

February 6, 2017

Study Completion

June 8, 2017

Last Updated

March 26, 2019

Record last verified: 2016-05