- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06570226
Discussion on the Effectiveness of Tea on Blood Pressure, Body Composition and Vision Problems in College Students
Background:
Tea is a universal beverage and one of the most popular drinks around the world. Some cell and animal experiments have pointed out that drinking tea may be related to hypotension, body composition and vision problems, and there are more and more related advertisements, especially for hibiscus tea, which is rich in anthocyanins. However, there is a lack of literature on the effectiveness of hibiscus tea drinks in preventing and treating blood pressure, body composition and vision problems in college students.
Purposes:
This study used a randomized human trial to evaluate the effects of drinking hibiscus tea on the control and reduction of blood pressure, body composition, and near vision problems. 100 subjects were divided into 2 groups: the hibiscus tea group and the boiled water drinking group, and they continued to drink it for 10 weeks. At the beginning of the trial (week zero), the second week, the sixth week, and the tenth week after stopping drinking, the visual fatigue scale, blood pressure, and body composition were examined respectively. At the initial stage (0th week) and at the 10th week after stopping drinking, visual acuity examinations were performed.
Expected results:
- To explore the effect of hibiscus tea drinks on subjects' myopia.
- To explore the effect of hibiscus tea drinks on visual fatigue of subjects.
- To explore the effect of hibiscus tea drinks on the blood pressure of subjects.
- To explore the impact of hibiscus tea drinks on the body composition of subjects.
- To explore the effect of hibiscus tea drinks on body fat of subjects.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Ciao-Lin Ho, PhD
- Phone Number: 5201, 5259 +886-4-26318652
- Email: swl8310@hk.edu.tw
Study Locations
-
-
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Taipei, Taiwan, 114
- Recruiting
- University of Kang Ning
-
Contact:
- Ciao-Lin Ho, PhD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- The inclusion criteria are college students aged 15 to 22 years old. -
Exclusion Criteria:
- hemodialysis patients who need to limit their water intake
- those with a history of gastric ulcers
- those allergic to anthocyanins
- those who have long-term consumption or consumption of beverages, foods or health products containing high anthocyanins that may interfere with the study after evaluation, for example: foods or health foods such as cranberries, blueberries, cherries and grapes.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: the hibiscus tea group
To drink the hibiscus tea for 10 weeks.
At the beginning of the trial (week zero), the second week, the sixth week, and the tenth week after stopping drinking, the visual fatigue scale, blood pressure, and body composition were examined respectively.
At the initial stage (0th week) and at the 10th week after stopping drinking, visual acuity examinations were performed.
|
Some cell and animal experiments have pointed out that drinking tea may be related to hypotension, body composition and vision problems, and there are more and more related advertisements, especially for hibiscus tea, which is rich in anthocyanins.
|
|
No Intervention: the boiled water drinking group
To drink the boiled water for 10 weeks.
At the beginning of the trial (week zero), the second week, the sixth week, and the tenth week after stopping drinking, the visual fatigue scale, blood pressure, and body composition were examined respectively.
At the initial stage (0th week) and at the 10th week after stopping drinking, visual acuity examinations were performed.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
To explore the effect of hibiscus tea drinks on subjects' myopia.
Time Frame: At the beginning of the trial (week zero) and the tenth week
|
At the beginning of the trial (week zero), and the tenth week after stopping drinking, Myopia (spherical equivalent refractive error, unit: diopter) was examined.
|
At the beginning of the trial (week zero) and the tenth week
|
|
To explore the effect of hibiscus tea drinks on visual fatigue of subjects.
Time Frame: At the beginning of the trial (week zero), the second week, the sixth week and the tenth week
|
At the beginning of the trial (week zero), the second week, the sixth week, and the tenth week after stopping drinking, the visual fatigue scale was examined by Visual Fatigue Questionnaire (Heuer et al,1989). Heuer, H., Hollendiek, G., Kröger, H., & Römer, T. (1989). Rest position of the eyes and its effect on viewing distance and visual fatigue in computer display work. Zeitschrift fur experimentelle und angewandte Psychologie, 36(4), 538-566. |
At the beginning of the trial (week zero), the second week, the sixth week and the tenth week
|
|
To explore the effect of hibiscus tea drinks on the blood pressure of subjects.
Time Frame: At the beginning of the trial (week zero), the second week, the sixth week and the tenth week
|
At the beginning of the trial (week zero), the second week, the sixth week, and the tenth week after stopping drinking, blood pressure (mmHg) was examined.
|
At the beginning of the trial (week zero), the second week, the sixth week and the tenth week
|
|
To explore the impact of hibiscus tea drinks on weight.
Time Frame: At the beginning of the trial (week zero), the second week, the sixth week and the tenth week
|
At the beginning of the trial (week zero), the second week, the sixth week, and the tenth week after stopping drinking, weight (kg) was examined.
|
At the beginning of the trial (week zero), the second week, the sixth week and the tenth week
|
|
To explore the impact of hibiscus tea drinks on muscle mass for body composition.
Time Frame: At the beginning of the trial (week zero), the second week, the sixth week and the tenth week
|
At the beginning of the trial (week zero), the second week, the sixth week, and the tenth week after stopping drinking, muscle mass (kg) was examined by the TANITA RD-545 (Tanita Corporation, Tokyo-Japonya).
Tanita Home Page.
Available online: https://tanita.eu/understanding-your-measurements
(accessed on 13 August 2022).
|
At the beginning of the trial (week zero), the second week, the sixth week and the tenth week
|
|
To explore the impact of hibiscus tea drinks on muscle quality for body composition.
Time Frame: At the beginning of the trial (week zero), the second week, the sixth week and the tenth week
|
At the beginning of the trial (week zero), the second week, the sixth week, and the tenth week after stopping drinking, muscle quality (MQ) was examined by the TANITA RD-545 (Tanita Corporation, Tokyo-Japonya).
MQ = muscle strength (kg)/muscle mass (kg).
Tanita Home Page.
Available online: https://tanita.eu/understanding-your-measurements
(accessed on 13 August 2022).
|
At the beginning of the trial (week zero), the second week, the sixth week and the tenth week
|
|
To explore the impact of hibiscus tea drinks on physique ratings for body composition.
Time Frame: At the beginning of the trial (week zero), the second week, the sixth week and the tenth week
|
At the beginning of the trial (week zero), the second week, the sixth week, and the tenth week after stopping drinking, physique ratings was examined by the TANITA RD-545 (Tanita Corporation, Tokyo-Japonya).
Physique ratings were determined as follows: 1-Hidden Excess Fat, 2-Medium Frame & Excess Fat, 3-Solidly Built, 4-Low Muscle, 5-Standard, 6-Muscular, 7-Low Muscle & Low Fat, 8-Thin & Muscular (Athlete), and 9-Very Muscular (Athlete).
Tanita Home Page.
Available online: https://tanita.eu/understanding-your-measurements
(accessed on 13 August 2022).
|
At the beginning of the trial (week zero), the second week, the sixth week and the tenth week
|
|
To explore the impact of hibiscus tea drinks on Visceral Fat for body composition.
Time Frame: At the beginning of the trial (week zero), the second week, the sixth week and the tenth week
|
At the beginning of the trial (week zero), the second week, the sixth week, and the tenth week after stopping drinking, Visceral Fat was examined by the TANITA RD-545 (Tanita Corporation, Tokyo-Japonya).
Based on all the available information it gives you a range between 1 and 59.
A rating between 1 and 12 indicates that you have a healthy level of visceral fat.
A rating between 13 and 59 indicates that you have an excessive level of visceral fat.Tanita Home Page.
Available online: https://tanita.eu/understanding-your-measurements
(accessed on 13 August 2022).
|
At the beginning of the trial (week zero), the second week, the sixth week and the tenth week
|
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To explore the impact of hibiscus tea drinks on BMR (Basal Metabolic Rate) for body composition.
Time Frame: At the beginning of the trial (week zero), the second week, the sixth week and the tenth week
|
At the beginning of the trial (week zero), the second week, the sixth week, and the tenth week after stopping drinking, BMR (kcal) was examined by the TANITA RD-545 (Tanita Corporation, Tokyo-Japonya).
Tanita Home Page, Available online: https://tanita.eu/understanding-your-measurements
(accessed on 13 August 2022).
|
At the beginning of the trial (week zero), the second week, the sixth week and the tenth week
|
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To explore the impact of hibiscus tea drinks on total body water (%) for body composition.
Time Frame: At the beginning of the trial (week zero), the second week, the sixth week and the tenth week
|
At the beginning of the trial (week zero), the second week, the sixth week, and the tenth week after stopping drinking, total body water (%) was examined by the TANITA RD-545 (Tanita Corporation, Tokyo-Japonya).
The ideal percentage for adult women will fluctuate between 45 and 60%, while the ideal percentage for adult men will be between 50 and 65% of the total body.
Tanita Home Page, Available online: https://tanita.eu/understanding-your-measurements
(accessed on 13 August 2022).
|
At the beginning of the trial (week zero), the second week, the sixth week and the tenth week
|
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To explore the impact of hibiscus tea drinks on BONE MASS for body composition.
Time Frame: At the beginning of the trial (week zero), the second week, the sixth week and the tenth week
|
At the beginning of the trial (week zero), the second week, the sixth week, and the tenth week after stopping drinking, BONE MASS (kg) was examined by the TANITA RD-545 (Tanita Corporation, Tokyo-Japonya).
Tanita Home Page, Available online: https://tanita.eu/understanding-your-measurements
(accessed on 13 August 2022).
|
At the beginning of the trial (week zero), the second week, the sixth week and the tenth week
|
|
To explore the impact of hibiscus tea drinks on BMI for body composition.
Time Frame: At the beginning of the trial (week zero), the second week, the sixth week and the tenth week
|
At the beginning of the trial (week zero), the second week, the sixth week, and the tenth week after stopping drinking, BMI (kg/m^2) was examined by the TANITA RD-545 (Tanita Corporation, Tokyo-Japonya).
Tanita Home Page, Available online: https://tanita.eu/understanding-your-measurements
(accessed on 13 August 2022).
|
At the beginning of the trial (week zero), the second week, the sixth week and the tenth week
|
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To explore the impact of hibiscus tea drinks on Metabolic age for body composition.
Time Frame: At the beginning of the trial (week zero), the second week, the sixth week and the tenth week
|
At the beginning of the trial (week zero), the second week, the sixth week, and the tenth week after stopping drinking, Metabolic age was examined by the TANITA RD-545 (Tanita Corporation, Tokyo-Japonya).
Tanita Home Page, Available online: https://tanita.eu/understanding-your-measurements
(accessed on 13 August 2022).
|
At the beginning of the trial (week zero), the second week, the sixth week and the tenth week
|
|
To explore the effect of hibiscus tea drinks on body fat percentage of subjects for body composition.
Time Frame: At the beginning of the trial (week zero), the second week, the sixth week and the tenth week
|
At the beginning of the trial (week zero), the second week, the sixth week, and the tenth week after stopping drinking, body fat percentage (%) was examined by the TANITA RD-545 (Tanita Corporation, Tokyo-Japonya). .
|
At the beginning of the trial (week zero), the second week, the sixth week and the tenth week
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CLHo
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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