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Mild to Moderate Sleep DisorderNCT07207252

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

A study testing Tea Theanine Casein Hydrolysate Pressed Candy and Pressed Candy in people with Mild to Moderate Sleep Disorder and Pressure, run by ChinaNorm at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 20 to 55 years
Conditions the study is for
Mild to Moderate Sleep Disorder, Pressure
What is being tested?
Tea Theanine Casein Hydrolysate Pressed Candy and Pressed Candy
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
171 participants
Where
1 siteChina
Study dates
28 Oct 2024to 5 Dec 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 55 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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,
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  • 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.
  • Chinese participants aged 23-55,
  • Right-handedness (not acquired through training),
  • Pressure group (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.

Who cannot join

  • Have used any food, health products, or medication with sleep aid and emotional relief effects within one month before the test,
  • History of tea allergy,
  • History of dairy product allergies,
  • Due to occupational reasons requiring night work or regular changes in working hours,
  • Regularly staying up late within one month before the test (not due to objective reasons or negative emotions, the frequency of staying up late is greater than once per week, such as playing games, watching TV shows, etc.),
  • Intending to become pregnant, or currently pregnant or breastfeeding,
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  • Currently treating diseases other than sleep disorders,
  • Using facial and eye skincare products with whitening and spot-removing effects,
  • Has a history of alcohol abuse,
  • There were unhealed skin lesions on the face currently,
  • Have undergone surgical procedures, plastic surgery, or organ transplantation in the past year,
  • Any other health problems or chronic illnesses other than sleep and emotions,
  • Other iatrogenic reasons considered by the expert or professional may influence the evaluation outcome.
  • Sub study 2:
  • Have used any food, health products, or medication with sleep aid and emotional relief effects within one month before the test,
  • History of tea allergy,
  • History of dairy product allergies,
  • Unable to effectively induce negative emotions during on-site testing (POMS stress scale and panic scale scores after emotional induction are not higher than baseline),
  • Before testing, any obvious physiological discomfort, including but not limited to fever, hunger, dysmenorrhea, cough, lack of sleep, etc.,
  • Frequent insomnia and irregular sleep patterns within a month,
  • Anemia,
  • Abnormal blood sugar and blood pressure,
  • Neurological disorders,
  • Self-reported neurological or emotional disorders such as depression, anxiety, bipolar disorder, and obsessive-compulsive disorder diagnosed by clinical psychiatrists,
  • Alcohol, cigarette addiction, or drug dependence,
  • During drug treatment, ①The individual has systematically taken hypnotic drugs (barbiturates, etc.) or other central nervous system drugs within one year. ②The individual has systematically used anti-anxiety drugs (Benzodiazepines such as diazepam, chlorpromazine, and clonazepam), antiepileptic drugs (such as phenobarbital or clonazepam), antipsychotic, antidepressant, and anti-dementia drugs within one year.
  • Intending to become pregnant, or currently pregnant or breastfeeding,
  • Other iatrogenic reasons considered by the expert or professional may influence the outcome of the evaluation.

Trial locations and contacts

1 site in 1 country.

China1 site
  • Shanghai China-norm Quality Technical Service Co., Ltd.

    Shanghai, Shanghai Municipality, 200072

Other trials in China

About this study

Official title: Sleep & Stress Test

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.

Being tested
Tea Theanine Casein Hydrolysate Pressed Candy, Pressed Candy
Keywords
Tea Theanine, Casein Hydrolysate, EEG, Emotion, Sleep Disorder
Medical subject headings
Sleep Wake Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Tea Theanine Casein Hydrolysate Pressed CandyDietary supplement

    Take 4 candies once a day. It is recommended to consume it one hour before bedtime.

  • Pressed CandyDietary supplement

    Take 4 candies once a day.

Study groups in NCT07207252
Study groupRoleWhat they receive
Tea Theanine Casein Hydrolysate Pressed CandyExperimentalTake 4 Tea Theanine Casein Hydrolysate Pressed Candies once a day.
Receives: Dietary Supplement: Tea Theanine Casein Hydrolysate Pressed Candy
Pressed CandyPlacebo comparatorTake 4 Pressed Candies once a day.
Receives: Dietary Supplement: Pressed Candy

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    The total score range is 0-21 points. The higher the score, the worse the sleep quality.

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

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

    The total score is calculated based on the average score of the questionnaire items, and then the average score is converted to a 0-100 scale using the formula: (average score - 1) * 25. The total score ranges from 0 to 100, with higher scores indicating better restorative sleep.

    Measured: 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)

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

    These indicators were collected by Huawei Smart Band HA580.

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

  4. 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)

    The sleep status of participants was tracked through sleep diaries.

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

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

    The total score is calculated based on the cumulative score of the questionnaire items, ranging from 0 to 40 points, with higher scores indicating greater perceived stress.

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

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

    The total score is calculated based on the cumulative score of the questionnaire items, ranging from 20 to 80 points, with higher scores indicating greater anxiety.

    Measured: T0 (baseline before consumption), T1d (after consumption for one day), T1wk (after consumption for one week), T4wk (after consumption for four weeks)

  7. Change in the scores of Profile of Mood States, POMS (28 Days Product Placement Test)

    The total score is calculated based on the cumulative score of the questionnaire items, ranging from 56 to 216 points. Higher scores indicate stronger negative emotions, reflecting a depressed mood and feelings of irritability.

    Measured: T0 (baseline before consumption), T1d (after consumption for one day), T1wk (after consumption for one week), T4wk (after consumption for four weeks)

  8. Change in the Skin tone evenness, Glossiness, ITA°, L, a, b, Dark circles (Under orbital pigmentation area) ITA°, L (28 Days Product Placement Test)

    All-face skin images under different light sources were captured by VISIA-CR (CANFIELD, America).

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

  9. Change in the Protrusion volume in Eye bag area (28 Days Product Placement Test)

    Protrusion volume in Eye bag area was measured by Primos (CANFIELD, America).

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

  10. Change in the Skin smoothness, softness, glossiness, hydration, tone evenness, Overall appearance (28 Days Product Placement Test)

    Dermatologists score the facial skin condition of participants using validated assessment scales (VAS). Scores for each dimension range from 0 to 9, and higher scores reflect a better skin condition.

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

  11. The improvement of dark circles and eye bags (28 Days Product Placement Test)

    Dermatologists evaluate the improvement of dark circles and eye bags in participants through baseline and follow-up visit VISIA photos, using an integrated visualization system (IVS) with improved investigator visual score. Each score range from 0 to 3, and higher scores represent a higher level of improvement.

    Measured: T1wk (after consumption for 1 week), T4wk (after consumption for 4 weeks)

  12. Change in the scores of Profile of Mood States, POMS (EEG Test)

    The sore of tension subscale ranges from 0 to 24 and confusion subscale ranges from 0 to 20, with higher scores indicating greater tension/confusion. The total score is calculated based on the cumulative score of the questionnaire items, ranging from 56 to 216 points. Higher scores indicate stronger negative emotions, reflecting a depressed mood and feelings of irritability.

    Measured: Before emotional induction (only tension and confusion scales), immediately after emotional induction, and 60 minutes after using the product

  13. Change in the Brain wave α power (EEG Test)

    EEG data was collected by Emotiv EPOC X, which is a wireless portable electroencephalograph used for scalable and contextualized brain research, with 14 channels on a 10-20 system, using saline electrode caps and a sampling rate set to 256 SPS. Electrodes were placed according to the electrode positioning of the 10-20 system.

    Measured: During emotion inducting, 60 minutes after consuming the product

  14. Change in the Brain wave β power (EEG Test)

    EEG data was collected by Emotiv EPOC X, which is a wireless portable electroencephalograph used for scalable and contextualized brain research, with 14 channels on a 10-20 system, using saline electrode caps and a sampling rate set to 256 SPS. Electrodes were placed according to the electrode positioning of the 10-20 system.

    Measured: During emotion inducting, 60 minutes after consuming the product

  15. Change in the Brain wave θ power (EEG Test)

    EEG data was collected by Emotiv EPOC X, which is a wireless portable electroencephalograph used for scalable and contextualized brain research, with 14 channels on a 10-20 system, using saline electrode caps and a sampling rate set to 256 SPS. Electrodes were placed according to the electrode positioning of the 10-20 system.

    Measured: During emotion inducting, 60 minutes after consuming the product

  16. Change in the Brain wave θ/β power ratio (EEG Test)

    EEG data was collected by Emotiv EPOC X, which is a wireless portable electroencephalograph used for scalable and contextualized brain research, with 14 channels on a 10-20 system, using saline electrode caps and a sampling rate set to 256 SPS. Electrodes were placed according to the electrode positioning of the 10-20 system.

    Measured: During emotion inducting, 60 minutes after consuming the product

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Oct 2025
  2. Study start28 Oct 2024
  3. Primary completion5 Dec 2024
  4. Study completion5 Dec 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
171 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07207252
Sponsor's protocol ID
W24002001
Status last verified
Sep 2025
First submitted
16 Sep 2025
Last updated
3 Oct 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A study testing Tea Theanine Casein Hydrolysate Pressed Candy and Pressed Candy in people with Mild to Moderate Sleep Disorder and Pressure, run by ChinaNorm at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in scores of Pittsburgh Sleep Quality Index, PSQI (28 Days Product Placement Test) (time frame: T0 (baseline before consumption), T1wk (after consumption for 1 week), T4wk (after consumption for 4 weeks)). The study lists 16 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2025; AzTrials last refreshed its copy on 7 Nov 2026.

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