The exploration of poly-gamma-glutamic acid and vitamin B6 in the sleep status of healthy adults in a clinical trial

Effects of polygamma glutamic acid and vitamin B6 supplementation on intestinal bacteria distribution

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0005083

Enrollment

Registered

2020-06-03

Start date

2018-10-10

Completion date

Unknown

Last updated

2020-06-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Dietary Supplement : *Types of intervention (3 types):All supplements were provided in a powder presentation. - Intervention A: poly-?-glutamic acid (?-PGA) (600 mg) OR placebo (corn starch 600mg) -

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Adult participants aged 20-65 years with no history of chronic disease including CVD, diabetes mellitus, cancer, hepatic disease, or kidney disease. All enrolled participants signed an informed consent form, which was approved by the Human Subjects Review Committee at the Kookmin University (KMU-201808-HR-184).

Exclusion criteria

Exclusion criteria: - Participants with regular use of drugs to treat the previously mentioned diseases - Pregnant - Those currently taking dietary supplements - Those diagnosed with allergic symptoms or with anemia diagnosis in the last three months.

Design outcomes

Primary

Measure	Time frame
Sleep duration;Sleep onset latency;Pittsburgh Sleep Quality Index (PSQI);Epworth Sleepiness Scale (ESS);Insomnia Severity Index (ISI);Caffeine intake;Serotonin	—

Secondary

Measure	Time frame
Change in the gut microbiome	—

Countries

Korea, Republic of

Contacts

Public ContactInkyung Baik

Kookmin University

Outcome results