Impact of Oligonol to Cardiometabolic Risk and Muscular Health

NCT03788577 | Completed

• 1 other identifier: 2018-05-004B
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

This project will mainly focus on Middle and old-aged adults, and examine whether Cardiovascular and metabolic risks can be reduced. In the meanwhile, this project will develop strategies for improving muscle loss , muscle strength decline, and the quality life of the elderly.

Conditions

Muscle Loss; Muscle Weakness; Quality of Life

Outcome Measures

Primary Outcomes (9)

• Changes from baseline muscle after 12 weeks

  Change from baseline muscle via MRI after 12 weeks.

  baseline,12 weeks

• Changes from baseline fat content of leg after 12 weeks

  Change from baseline fat content of leg via MRI after 12 weeks.

  baseline,12 weeks

• Changes form baseline chair-stand after 12 weeks

  measured by the time of chair-stand after 12 weeks.

  baseline, 12 weeks

• Changes form baseline muscle strength after 12 weeks

  measured by hand grip distance after 12 weeks.

  baseline, 12 weeks

• Change from baseline Nutrition intake after 12 weeks

  measured by Mini-nutritional assessment questionnaire. ranged 0-30, higher values represent a better condition

  baseline, 12 weeks

• Change from baseline depression after 12 weeks

  measured by the Center for Epidemiological Studies-Depression (CES-D) ranged 0-60, higher values represent a worse condition

  baseline, 12 weeks

• Change from baseline endurance after 12 weeks

  measured by 6-minute walk distance

  baseline, 12 weeks

• Change from baseline walking speed after 12 weeks

  measured by six-meter walking speed

  baseline, 12 weeks

• Change from baseline timed up and go test after 12 weeks

  measured by timed up and go test (TUG)

  baseline, 12 weeks

Secondary Outcomes (16)

• Change from baseline numbers of Complete blood count after 12 weeks

  baseline,12 weeks

• Change from baseline concentration of Albumin after 12 weeks

  baseline,12 weeks

• Change from baseline concentration of Alanine Aminotransferase (ALT) after 12 weeks.

  baseline,12 weeks

• Change from baseline concentration of Aspartate Aminotransferase (AST) after 12 weeks.

  baseline,12 weeks

• Change from baseline concentration of blood urea nitrogen after 12 weeks

  baseline,12 weeks

Study Arms (2)

Oligonol intake group

EXPERIMENTAL

This experimental arm will be applied for Oligonol 200mg/tab 1 tab per day. The program will last for 12 weeks.

Dietary Supplement: Oligonol intake

Placebo group

PLACEBO COMPARATOR

This Placebo arm will be given capsules made of starch 1 tab per day. The program will last for 12 weeks.

Dietary Supplement: Placebo

Interventions

Oligonol intake DIETARY_SUPPLEMENT

Major intervention of Oligonol component , as suggested Oligonol safe dose for adults is 200mg per day.

Oligonol intake group

Placebo DIETARY_SUPPLEMENT

Placebo

Placebo group

Eligibility Criteria

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

You may qualify if:

• People who aged more than 50 years
• Patients with following characteristics:
• feeling loss in activity.
• detecting decline in self's walking speed.
• feeling tired of doing everything.
• having fallen down last year.
• People can accept undergoing MRI
• People willing to follow the program and cooperate with us for following tracking.
• People who are neither vegan nor vegetarian

You may not qualify if:

• Walking speed less than 0.3m/s
• People with any disease affecting their limbs, including:
• having fracture on limbs in the past 6 months.
• having severe arthritis in the past 6 months
• any other whom PI recognized as weak control of their nervous system( e.g.: Parkinson's disease and stroke).
• People with intermittent limp caused by peripheral artery diseases
• People with weak control of mental disorder
• People with weak control of Cardiopulmonary disease
• People with weak control of Malignant tumor
• People with weak control of kidney diseases (GFR \< 30 mL/min/1.73 m2 for at least 3 months)
• People with visual impairment and hearing disorder who cannot complete the program.
• People who are unable to undertake MRI
• Any other condition that PI recognized as not suitable.

Sponsors & Collaborators

• National Yang Ming Chiao Tung University: lead

Study Sites (1)

Taipei Veteran General Hospital

Taipei, 112, Taiwan

Location

MeSH Terms

Conditions

Muscular Atrophy; Muscle Weakness

Condition Hierarchy (Ancestors)

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

Study Officials

• Liang-Kung Chen, MD.PhD.

  Center for Healthy Longevity and Aging Sciences, National Yang Ming University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 19, 2018
• First Posted: December 27, 2018
• Study Start: December 4, 2018
• Primary Completion: April 1, 2020
• Study Completion: April 1, 2020
• Last Updated: April 14, 2023

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)