Effect of Fermented Prunus Mume Vinegar on Improvement of Fatigue

Effect of Fermented Prunus Mume Vinegar on Improvement of Fatigue: a Randomized Controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Fatigue
• Intervention / Treatment: Dietary supplement: Fermented Prunus Mume Vinegar group; Dietary supplement: Placebo group

Detailed Description

Previous studies have indicated that Fermented Prunus Mume Vinega may have the ability to improve fatigue. Therefore, the investigators conduct a randomized, double-blind, placebo-controlled study to investigate the effects of tFermented Prunus Mume Vinega on Improvement of Fatigue in adults; the safety of the compound are also evaluate. The Investigators examine fatigue severity scale, lactate, creatinine kinase, urinary malondialdehyde at baseline, as well as after 4 and 8 weeks of intervention. Sixty adults were administered either 600 mg of Fermented Prunus Mume Vinega or a placebo each day for 8 weeks;

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Gyeungsangnam-do
    • Yangsan, Gyeungsangnam-do, Korea, Republic of, 50612
      • Pusan National University Yangsan Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Fermented Prunus Mume Vinegar group; This group takes Fermented Prunus Mume Vinegar for 8 weeks.	Dietary supplement: Fermented Prunus Mume Vinegar group; This group takes Fermented Prunus Mume Vinegar for 8 weeks
PLACEBO_COMPARATOR: Placebo group; This group takes placebo for 8 weeks.	Dietary supplement: Placebo group; This group takes placebo for 8 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fatigue severity scale	Fatigue severity scale, minimum~maximum values (1~7), higher scores mean a worse outcome.	8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Lactate level	Lactate level (mg/dL)	8 weeks
Creatinine kinase level	Creatinine kinase level (IU/L)	8 weeks
Urinary malondialdehyde level	Urinary malondialdehyde level (mmol/mg Cr)	8 weeks

Collaborators and Investigators

• Sponsor: Pusan National University Yangsan Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 19, 2020
• Primary Completion (ACTUAL): December 30, 2020
• Study Completion (ACTUAL): December 31, 2020

Study Registration Dates

• First Submitted: March 21, 2020
• First Submitted That Met QC Criteria: March 23, 2020
• First Posted (ACTUAL): March 24, 2020

Study Record Updates

• Last Update Posted (ACTUAL): April 28, 2021
• Last Update Submitted That Met QC Criteria: April 27, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Fatigue; Anti-Infective Agents; Anti-Bacterial Agents; Acetic Acid
• Other Study ID Numbers: 02-2018-030

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No