The Efficacy Evaluation of Buckwheat Husk Extract on Cardiovascular Disease Risk Factors

Sponsor
TCI Co., Ltd. (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04490720
Collaborator
(none)
60
1
2
13.2
4.5

Study Details

Study Description

Brief Summary

To assess the efficacy evaluation of buckwheat husk extract on cardiovascular disease risk factors

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: Placebo
  • Dietary Supplement: Buckwheat husk extract
N/A

Detailed Description

This is a double-blind and randomized study. Subjects are informed to consume the samples every day for 2 months. The clinical diagnosis item of cardiovascular disease is evaluated by the doctor.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
The Efficacy Evaluation of Buckwheat Husk Extract on Cardiovascular Disease Risk Factors
Actual Study Start Date :
Nov 24, 2021
Anticipated Primary Completion Date :
Oct 31, 2022
Anticipated Study Completion Date :
Dec 31, 2022

Arms and Interventions

Arm Intervention/Treatment
Placebo Comparator: Placebo

consume 1 sachet per day for 2 months

Dietary Supplement: Placebo
consume 1 sachet per day for 2 months

Experimental: Buckwheat husk extract

consume 1 sachet per day for 2 months

Dietary Supplement: Buckwheat husk extract
consume 1 sachet per day for 2 months

Outcome Measures

Primary Outcome Measures

  1. Change from baseline in blood pressure (systolic blood pressure, diastolic blood pressure) [Days 1, 28, and 56]

    Blood pressure will be measured at the beginning, 4-week, and 8-week time points.

Secondary Outcome Measures

  1. Change from baseline in Body Mass Index (BMI) [Days 1, 28, and 56]

    Body Mass Index (kg/m^2) will be measured at the beginning, 4-week, and 8-week time points. P.S. weight in kilograms, height in meters

  2. Change from baseline in waist-hip ratio [Days 1, 28, and 56]

    Waist-hip ratio will be measured at the beginning, 4-week, and 8-week time points.

  3. Change from baseline in blood lipid (total-Cholesterol, triglyceride, HDL-C, LDL-C) [Days 1, 28, and 56]

    Blood lipid will be measured at the beginning, 4-week, and 8-week time points.

  4. Change from baseline in blood cardiovascular disease risk biomarker (hs-CRP, NO, Trimethylamine-N-oxide) [Days 1, 28, and 56]

    Blood cardiovascular disease risk biomarker will be measured at the beginning, 4-week, and 8-week time points.

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  1. 20 to 65-year-old males or non-pregnant females who are willing to sign the subject's consent.

  2. The systolic blood pressure is 121-139 mmHg and the diastolic blood pressure is between 81-89 mmHg.

  3. Those who are not pregnant and are willing to cooperate with contraception during the trial period.

  4. No history of organ transplantation, epilepsy or convulsions, liver or kidney disease, malignant tumor, endocrine disease, mental disease, alcohol or drug abuse, or other major organic diseases (according to medical history).

Exclusion Criteria:
  1. Pregnant women.

  2. People with a history of organ transplantation, epilepsy or convulsions, liver and kidney disease, malignant tumors, endocrine diseases, mental illness, alcohol or drug abuse, and other major organic diseases (according to medical history).

  3. No person has undergone major surgery.

Contacts and Locations

Locations

Site City State Country Postal Code
1 National Taiwan University Hospital Taipei Taiwan 114

Sponsors and Collaborators

  • TCI Co., Ltd.

Investigators

  • Principal Investigator: Mao-Hsin Lin, Doctor, National Taiwan University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
TCI Co., Ltd.
ClinicalTrials.gov Identifier:
NCT04490720
Other Study ID Numbers:
  • 201911003RSC
First Posted:
Jul 29, 2020
Last Update Posted:
Nov 26, 2021
Last Verified:
Oct 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 26, 2021