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 range

20 Years – 55 Years

Sex

ALL

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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)

Trial details

NCT IDNCT07207252

SponsorChinaNorm

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-12-05

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