Development of Green Mei Products for the Prevention of Metabolic Syndrome

Study Overview
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Brief Summary
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The aim of this study is to investigate the antihypertensive effects of Mei-Gin formula-4 (MGF-4) and Mei-Gin formula-7.

Detailed Description
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It's a randomized, and single-blind trial and was designed to evaluate the effects of MGFs (MGF-4 and MGF-4) on blood pressure. 50 participants with hypertension (systolic blood pressure between 130-179 mmHg or diastolic blood pressure between 85-109 mmHg) who did not accept any hypertension medication were randomized allocated to either MGF-4 or MGF-7 group. Participants were instructed to take 4 capsules of MGF-4 or MGF-7 daily throughout the duration of the 8 weeks intervention study. After treatment, the change of the blood pressure and relative mechanism were analyzed.

Official Title
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Development of Green Mei Products for the Prevention of Metabolic Syndrome

Conditions
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Hypertension

Intervention / Treatment
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* Dietary Supplement: MGF-4
* Dietary Supplement: MGF-7


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The age of the subject is 20 to 70 years old. The subject is a patient with hypertension (SBP is between 130-179 mmHg, DBP is between 85-109mmHg, one of the two can be diagnosed), and there are no serious illnesses requiring hospitalization during the study period treatment. No hypertension medication. The subject can understand the test process described in the consent form and the possible potential risks and benefits, and able to sign the consent form. The subjects shall observe diet control during the trial period. Exclusion Criteria: Subjects diagnosed with cancer and still under active treatment. Subjects diagnosed with heart disease and still under active treatment. Other drugs are used, whose pharmacological effects may affect blood pressure or may aggravate the effects of drugs. Subjects who have systemic infection and need systemic antibiotics.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MGF-4<br>Take two MGF-4 capsules twice a day for 8 weeks. A 250 mg capsule contents 243 mg MGF-4 and other excipients. | Dietary Supplement: MGF-4<br>* Participants were instructed to take 2 capsules of MGF-4 twice a day, and measure own blood pressure at morning everyday throughout the duration of the study.<br>|
| Experimental: MGF-7<br>Take two MGF-7 capsules twice a day for 8 weeks. A 250 mg capsule contents 243 mg MGF-7 and other excipients. | Dietary Supplement: MGF-7<br>* Participants were instructed to take 2 capsules of MGF-7 twice a day, and measure own blood pressure at morning everyday throughout the duration of the study.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change the blood pressure after intervention | Compare the difference of own SBP and DBP between the week 0, 4 and 8 in each groups | Week 0, 4 and 8 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline serum MDA and TEAC at Week 8 | Compare the difference of serum MDA and TEAC between week 0 and 8 | Week 0 and 8 |