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

ChinaNorm

Status: Completed

Conditions: Mild to Moderate Sleep Disorder; Pressure

Treatments: Dietary Supplement: Tea Theanine Casein Hydrolysate Pressed Candy; Dietary Supplement: Pressed Candy

Study type: Interventional

Funder types: Industry

Identifiers

NCT07207252

W24002001

Details and patient eligibility

About

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.

Enrollment: 171 patients

Sex: All

Ages: 20 to 55 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Sub study 1:

Inclusion Criteria:

1. Chinese participants aged 20-55,
2. Mild to moderate sleep disorders (Pittsburgh Sleep Quality Index 5-21),
3. At least 2/3 of the population is under pressure (PSS-10 ≥ 14),
4. No plans to leave Shanghai in the past three months,
5. Have basic Chinese reading comprehension and expression abilities and can independently complete the questionnaire survey,
6. Voluntarily participate in the test and sign an informed consent form,
7. 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:

1. Have used any food, health products, or medication with sleep aid and emotional relief effects within one month before the test,
2. History of tea allergy,
3. History of dairy product allergies,
4. Due to occupational reasons requiring night work or regular changes in working hours,
5. 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.),
6. Intending to become pregnant, or currently pregnant or breastfeeding,
7. Currently treating diseases other than sleep disorders,
8. Using facial and eye skincare products with whitening and spot-removing effects,
9. Has a history of alcohol abuse,
10. There were unhealed skin lesions on the face currently,
11. Have undergone surgical procedures, plastic surgery, or organ transplantation in the past year,
12. Any other health problems or chronic illnesses other than sleep and emotions,
13. Other iatrogenic reasons considered by the expert or professional may influence the evaluation outcome.

Sub study 2：

Inclusion Criteria:

1. Chinese participants aged 23-55,
2. Right-handedness (not acquired through training),
3. Pressure group (PSS-10 ≥ 14),
4. No plans to leave Shanghai in the past three months,
5. Have basic Chinese reading comprehension and expression abilities, and can independently complete the questionnaire survey,
6. Voluntarily participate in the test and sign an informed consent form,
7. Willing to comply with all evaluation requirements, use the product according to the research protocol, and complete testing.

Exclusion Criteria:

1. Have used any food, health products, or medication with sleep aid and emotional relief effects within one month before the test,
2. History of tea allergy,
3. History of dairy product allergies,
4. 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),
5. Before testing, any obvious physiological discomfort, including but not limited to fever, hunger, dysmenorrhea, cough, lack of sleep, etc.,
6. Frequent insomnia and irregular sleep patterns within a month,
7. Anemia,
8. Abnormal blood sugar and blood pressure,
9. Neurological disorders,
10. Self-reported neurological or emotional disorders such as depression, anxiety, bipolar disorder, and obsessive-compulsive disorder diagnosed by clinical psychiatrists,
11. Alcohol, cigarette addiction, or drug dependence,
12. 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.
13. Intending to become pregnant, or currently pregnant or breastfeeding,
14. Other iatrogenic reasons considered by the expert or professional may influence the outcome of the evaluation.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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171 participants in 2 patient groups, including a placebo group

Tea Theanine Casein Hydrolysate Pressed Candy

Experimental group

Description:

Take 4 Tea Theanine Casein Hydrolysate Pressed Candies once a day.

Treatment:

Dietary Supplement: Tea Theanine Casein Hydrolysate Pressed Candy

Pressed Candy

Placebo Comparator group

Description:

Take 4 Pressed Candies once a day.

Treatment:

Dietary Supplement: Pressed Candy