Ganmaidazao Concentrated Beverage Sleep-Assisting Trial

Overview

A human trial with blind method and self-control design was carried out to evaluate the sleep-improving function of a food. Indicators were detected by professional instruments and self-assessed by subjects. Relevant data before and after 28 consecutive days of test sample administration were collected for comparative analysis.

Detailed description

The objective of this clinical trial is to evaluate whether a food product has the effect of improving sleep. The primary research question is: does a full course of consumption improve sleep outcomes in study participants? This is a single-arm trial comparing participants' sleep status before and after consumption of the test product.

Study participants will:

Consume the test article daily for 28 consecutive days Attend clinic assessments at baseline (prior to trial initiation) and after the 28-day intervention period Maintain daily sleep diaries throughout the study period

Interventions

• Other Sleep-improving Functional Food
  28 days of daily consumption of test functional food; sleep assessment via baseline check-up and daily sleep diaries, single-arm self-controlled study.

Primary outcome measures

• Pittsburgh Sleep Quality Index (PSQI) Total Score [Time frame: Baseline and Day 28]

Secondary outcome measures (12)

• Fatigue Scale-14 (FS-14) Total Fatigue Score [Time frame: Baseline (Day 0) and Day 28]
• Spiegel Sleep Questionnaire Total Score [Time frame: Baseline (Day 0) and Day 28]
• Change in Objective Total Sleep Time [Time frame: Baseline (Day 0) through Day 28 (daily monitoring)]
• Salivary melatonin [Time frame: Pre-intervention: Day 0 and Day 1; Post-intervention: Day 27 and Day 28. Three sampling time points within 2 hours before bedtime on each collection day.]
• Salivary cortisol [Time frame: Day 0, Day 1, Day 27, Day 28; four serial sampling points within 45 minutes upon waking each collection day.]
• Change in Objective Sleep Efficiency [Time frame: Baseline (Day 0) through Day 28 (daily monitoring)]
• Change in Objective Deep Sleep Duration [Time frame: Baseline (Day 0) through Day 28 (daily monitoring)]
• Change in Objective Sleep Onset Latency [Time frame: Baseline (Day 0) through Day 28 (daily monitoring)]
• Change in Actual Bedtime Recorded via Daily Sleep Diary [Time frame: Baseline (Day 0) through Day 28 (daily self-report sleep diary)]
• Change in Wake-up Time Recorded via Daily Sleep Diary [Time frame: Baseline (Day 0) through Day 28 (daily self-report sleep diary)]
• Change in Perceived Sleep Quality from Daily Sleep Diary [Time frame: Baseline (Day 0) through Day 28 (daily self-report sleep diary)]
• Change in Number of Nighttime Awakenings Recorded via Daily Sleep Diary [Time frame: Baseline (Day 0) through Day 28 (daily self-report sleep diary)]

Eligibility criteria

Inclusion criteria

• Aged 18 to 60 years of any gender, with a history of staying up late or mild sleep disorder, and Pittsburgh Sleep Quality Index (PSQI) score between 7 and 15 points (mild to moderate sleep impairment).
• Regular daily schedule with bedtime from 22:00 to 24:30 and wake-up time from 6:30 to 8:30; long-term daily schedule fluctuation ≤ 2 hours, and able to maintain a fixed schedule throughout the trial.
• No abnormal saliva secretion and capable of completing saliva sample collection independently and normally.
• Body Mass Index (BMI) ranging from 18.5 to 28.0, without extreme emaciation or obesity.
• Able to participate in pre-trial centralized training and operational assessments (including wearable bracelet wearing, saliva collection, and questionnaire filling), and pass the assessment before enrollment.
• No intake of sleep aids, anti-anxiety drugs, antidepressants, central nervous system regulators, sleep-improving health foods and related products within 2 weeks prior to enrollment.
• Free from severe organic diseases, including cardiovascular and cerebrovascular diseases, liver and kidney dysfunction, psychiatric disorders, and nervous system diseases.
• Free from severe sleep disorder subtypes, such as obstructive sleep apnea syndrome.
• No history of allergy to the ingredients and excipients of the test product, and voluntarily sign the informed consent form.

Exclusion criteria

• Aged under 18 years or over 60 years.
• Current smokers, or subjects with alcohol drinking habits of ≥3 times per week who have not quit alcohol within one month before the trial.
• Long-term intake of stimulating beverages, defined as drinking strong tea, coffee or energy drinks ≥3 cups per day.
• Experienced drastic changes in diet or daily routine within one month before enrollment, such as frequent business trips, travel, shift work, or dramatic dietary habit changes.
• Diagnosed with severe sleep disorders or obstructive sleep apnea syndrome.
• Participated in other human clinical trials, received professional sleep intervention therapy, or consumed products containing N-acetylneuraminic acid within one month before enrollment.
• Pregnant or lactating females, or those planning to become pregnant within one year.
• Long-term shift workers, regular severe night owls, or subjects with extremely unstable sleeping environments.
• Intolerant to wearing smart wearable bracelets or unable to cooperate with trial-related examinations and sample collection.
• Staff of the trial institution and other personnel involved in this project.
• Scheduled to receive surgical treatment during the trial period.
• With a history of severe food or drug allergies.
• Diagnosed with digestive system organic lesions such as gastrointestinal ulcers and bleeding.
• Suffering from severe physical and mental illnesses under treatment, severe cardiovascular, cerebrovascular and hematological diseases, severe liver and kidney dysfunction, pulmonary infection or malignant tumors.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Supportive care

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07726719 · GZ260430087

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗