The exploration of poly-gamma-glutamic acid and vitamin B6 in the sleep status of healthy adults in a clinical trial
- Conditions
- Endocrine, nutritional and metabolic disease
- Registration Number
- KCT0005083
- Lead Sponsor
- ational Research Foundation
- Brief Summary
Data regarding the effects of poly-?-glutamic acid (?-PGA) on sleep are limited. This study aimed to test whether ?-PGA and vitamin B6 (VitB6) supplements improve sleep. A factorial randomised, double-blinded, placebo-controlled crossover study included 47 adults absent of chronic diseases or under medical treatment. Stratified randomised allocation considered age and gender for the three intervention groups: A-supplementation with ?-PGA (600mg) alone (n=16), B-supplementation with VitB6 (100 mg) alone (n=14), and dual C-supplementation of these two compounds (n=17). Participants underwent a one-month intervention period, followed by a one-month washout period, and then a second one-month intervention period. Before and after intervention periods, information about nighttime sleep status was collected at Kookmin University (KMU). Differences in sleep status before and after supplementation were compared between the placebo and intervention groups using non-parametric tests finding significant statistical differences in the dual C-supplementation intervention: an increase in sleep duration (0.27±0.98 hour, p <0.05) (A-Supplementation=-0.03±0.71, p=0.23; B-supplementation=0.67±0.80, p=0.60) and a reduction in Pittsburgh Sleep Quality Index global score (-0.52±1.58, p <0.05). No side effects were reported. On the basis of these findings, C-supplementation may be effective as functional food components to improve nighttime sleep. The protocol was approved by KMU IRB (KMU-201808-HR-184). Funding by the Korean government (2017R1A2A2A05001380).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 47
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).
- 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.
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Sleep duration;Sleep onset latency;Pittsburgh Sleep Quality Index (PSQI);Epworth Sleepiness Scale (ESS);Insomnia Severity Index (ISI);Caffeine intake;Serotonin
- Secondary Outcome Measures
Name Time Method Change in the gut microbiome