NCT06570226

Brief Summary

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:

  1. 1.To explore the effect of hibiscus tea drinks on subjects' myopia.
  2. 2.To explore the effect of hibiscus tea drinks on visual fatigue of subjects.
  3. 3.To explore the effect of hibiscus tea drinks on the blood pressure of subjects.
  4. 4.To explore the impact of hibiscus tea drinks on the body composition of subjects.
  5. 5.To explore the effect of hibiscus tea drinks on body fat of subjects.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2024

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 26, 2024

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

August 14, 2024

Completed
12 days until next milestone

First Posted

Study publicly available on registry

August 26, 2024

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 25, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 25, 2025

Completed
Last Updated

August 26, 2024

Status Verified

August 1, 2024

Enrollment Period

12 months

First QC Date

August 14, 2024

Last Update Submit

August 21, 2024

Conditions

Keywords

Roselle teamyopiacollege studentsbody compositionanthocyanin

Outcome Measures

Primary Outcomes (14)

  • To explore the effect of hibiscus tea drinks on subjects' myopia.

    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.

    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.

    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.

    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.

    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.

    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.

    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.

    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

  • To explore the impact of hibiscus tea drinks on BMR (Basal Metabolic Rate) for body composition.

    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

  • To explore the impact of hibiscus tea drinks on total body water (%) for body composition.

    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

  • To explore the impact of hibiscus tea drinks on BONE MASS for body composition.

    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.

    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

  • To explore the impact of hibiscus tea drinks on Metabolic age for body composition.

    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.

    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

Study Arms (2)

the hibiscus tea group

EXPERIMENTAL

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.

Dietary Supplement: hibiscus tea

the boiled water drinking group

NO INTERVENTION

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.

Interventions

hibiscus teaDIETARY_SUPPLEMENT

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.

the hibiscus tea group

Eligibility Criteria

Age15 Years - 22 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Kang Ning

Taipei, 114, Taiwan

RECRUITING

MeSH Terms

Conditions

MyopiaAsthenopia

Condition Hierarchy (Ancestors)

Refractive ErrorsEye Diseases

Central Study Contacts

Ciao-Lin Ho, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

August 14, 2024

First Posted

August 26, 2024

Study Start

July 26, 2024

Primary Completion

July 25, 2025

Study Completion

July 25, 2025

Last Updated

August 26, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

Locations