Effect of Fermented Prunus Mume Vinegar on Improvement of Fatigue

NCT04319692 | Completed

• 1 other identifier: 02-2018-030
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators conduct a randomized, double-blind, placebo-controlled study to investigate the effects of Fermented Prunus Mume Vinega on Improvement of Fatigue in adults for 8 weeks.

Conditions

Fatigue

Outcome Measures

Primary Outcomes (1)

• Fatigue severity scale

  Fatigue severity scale, minimum\~maximum values (1\~7), higher scores mean a worse outcome.

  8 weeks

Secondary Outcomes (3)

• Lactate level

  8 weeks

• Creatinine kinase level

  8 weeks

• Urinary malondialdehyde level

  8 weeks

Study Arms (2)

Fermented Prunus Mume Vinegar group

EXPERIMENTAL

This group takes Fermented Prunus Mume Vinegar for 8 weeks.

Dietary Supplement: Fermented Prunus Mume Vinegar group

Placebo group

PLACEBO COMPARATOR

This group takes placebo for 8 weeks.

Dietary Supplement: Placebo group

Interventions

Fermented Prunus Mume Vinegar group DIETARY_SUPPLEMENT

This group takes Fermented Prunus Mume Vinegar for 8 weeks

Fermented Prunus Mume Vinegar group

Placebo group DIETARY_SUPPLEMENT

This group takes placebo for 8 weeks.

Placebo group

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Those who complain of fatigue for more than 1 month
• Fatigue Severity Scale 3 points or more

You may not qualify if:

• chronic hepatitis B or C infection
• being treated for hypothyroidism or hyperthyroidism
• more than twice the normal upper limit of Creatinine
• Liver enzyme value is more than twice the normal upper limit
• Uncontrolled diabetes (over 160 mg / dl of fasting blood sugar)
• Uncontrolled hypertension (more than 160/100 mmHg, measured after 10 minutes of stability in subjects) or those with heart disease, such as angina or myocardial infarction
• taking medications that affect fatigue within the past 1 month (psychiatric drugs such as Chinese medicine, soy drugs, depression, beta-blockers, steroids, hormones, etc.). However, intermittent medication due to sleep disorders is excluded.
• a history of gastrointestinal resection or complain of severe gastrointestinal symptoms such as heartburn and indigestion
• already have participated in or plan to participate in another drug clinical trial
• Alcohol abusers
• pregnant, lactating or have a pregnancy plan during the clinical trial period
• allergic reactions to Fermented Prunus Mume Vinegar
• A person deemed inappropriate by the researcher for other reasons

Sponsors & Collaborators

• Pusan National University Yangsan Hospital: lead

Study Sites (1)

Pusan National University Yangsan Hospital

Yangsan, Gyeungsangnam-do, 50612, South Korea

Location

Related Publications (1)

• Choi JI, Lee YL, Lee SY. Efficacy and safety of fermented Prunus mume vinegar on fatigue improvement in adults with unexplained fatigue: A randomized controlled trial. Front Nutr. 2022 Nov 9;9:990418. doi: 10.3389/fnut.2022.990418. eCollection 2022.

  PMID: 36438753 DERIVED

MeSH Terms

Conditions

Fatigue

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Sang Yeoup Lee

  Pusan National University Yangsan Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 21, 2020
• First Posted: March 24, 2020
• Study Start: March 19, 2020
• Primary Completion: December 30, 2020
• Study Completion: December 31, 2020
• Last Updated: April 28, 2021

Record last verified: 2021-04

Locations

KR (1)