CompletedNot Applicable

Research on Sleep and Emotion Testing of Tea Theanine Casein Hydrolysate Pressed Candy

China171 participantsStarted 2024-10-28

Plain-language summary

The study evaluates the improvement of sleep, emotion, and skin by standardizing the use of the blend (Tea Theanine Casein Hydrolysate Pressed Candy, whose active ingredients include Tea Theanine, Casein Hydrolysate, and Saffron Extract). This is a randomized, double-blind trial for Chinese people aged 20-55. The change of sleep, emotion, skin, and other related indicators of 90 participants after taking Tea Theanine Casein Hydrolysate Pressed Candy, whose active ingredients include tea theanine, casein hydrolysate, and saffron extract, was evaluated through a 28 days product placement test (sub study 1), and the emotional change of 70 participants after taking Tea Theanine Casein Hydrolysate Pressed Candy was evaluated through an EEG test (sub study 2). Participants who meet the inclusion criteria were randomly assigned to use the experimental product or the placebo control. In sub study 1, 90 participants completed a 7-day baseline period, a 28-day testing period (T1d, T7d, and T28d). In sub study 2, 71 participants completed a single on-site test.

Who can participate

Age range20 Years – 55 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Chinese participants aged 20-55,
✓. Mild to moderate sleep disorders (Pittsburgh Sleep Quality Index 5-21),
✓. At least 2/3 of the population is under pressure (PSS-10 ≥ 14),
✓. No plans to leave Shanghai in the past three months,
✓. Have basic Chinese reading comprehension and expression abilities and can independently complete the questionnaire survey,
✓. Voluntarily participate in the test and sign an informed consent form,
✓. Willing to comply with all evaluation requirements, use the product according to the research protocol, and complete testing and follow-up. During the trial period, do not change the original dietary or skincare habits or use other similar foods, health products, or drugs.

Exclusion criteria

✕. Have used any food, health products, or medication with sleep aid and emotional relief effects within one month before the test,
✕

What they're measuring

Change in scores of Pittsburgh Sleep Quality Index, PSQI (28 Days Product Placement Test)

Timeframe: T0 (baseline before consumption), T1wk (after consumption for 1 week), T4wk (after consumption for 4 weeks)

Change in scores of Restorative Sleep Questionnaire Weekly Version (RSQ-W) and Daily Version (RSQ-D) (28 Days Product Placement Test)

Timeframe: T0 (baseline before consumption, RSQ-W was used), T1d (after consumption for one day, RSQ-D was used), T1wk (after consumption for one week, RSQ-W was used), T4wk (after consumption for four weeks, RSQ-W was used)

Change in the Fall asleep time, Nighttime sleep duration, Shallow sleep duration, Shallow sleep ratio and Sleep latency (28 Days Product Placement Test)

Timeframe: Continuous collection during placement (7-day baseline+28-day product placement test)

Change in the Wakefulness frequency, Sleep quality, Sleepiness in the morning, Refreshment in the morning, mood in the morning, Sleep latency (28 Days Product Placement Test)

Timeframe: Continuous collection during placement (7-day baseline+28-day product placement test)

Change in the scores of Perceived Stress Scale, PSS-10 (28 Days Product Placement Test)

Timeframe: T0 (baseline before consumption), T1wk (after consumption for one week), T4wk (after consumption for four weeks)

Change in the scores of The State-Trait Anxiety Inventory, the S-Form, S-AI (28 Days Product Placement Test)

Trial details

NCT IDNCT07207252

SponsorChinaNorm

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-12-05

View on ClinicalTrials.gov More Mild to Moderate Sleep Disorder trials