Status:

COMPLETED

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

Lead Sponsor:

ChinaNorm

Collaborating Sponsors:

Nu Skin Enterprises

Conditions:

Mild to Moderate Sleep Disorder

Pressure

Eligibility:

All Genders

20-55 years

Phase:

NA

Brief 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, Cas...

Eligibility Criteria

Inclusion

  • Sub study 1:
  • 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

  • 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,
  • 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:
  • Inclusion Criteria:
  • 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.

Key Trial Info

Start Date :

October 28 2024

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

December 5 2024

Estimated Enrollment :

171 Patients enrolled

Trial Details

Trial ID

NCT07207252

Start Date

October 28 2024

End Date

December 5 2024

Last Update

October 3 2025

Active Locations (1)

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Page 1 of 1 (1 locations)

1

Shanghai China-norm Quality Technical Service Co., Ltd.

Shanghai, Shanghai Municipality, China, 200072