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Effects of Supplementation of Compound Nutrients on Plasma Homocysteine in Chinese Adults With Hyperhomocysteinemia

Primary Purpose

Hyperhomocysteinemia

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
supplementation of compound nutrients
placebo control
Sponsored by
Huilian Zhu
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Hyperhomocysteinemia

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. People aged 18-65 years.
  2. The level of plasma homocysteine is 15-100μmol/L.
  3. Free from products which could decrease plasma homocysteine for at least one month.
  4. Willing to participate in the study, consume the test product and perform all measurements.

Exclusion Criteria:

  1. pregnant or lactating women.
  2. severe diseases need to control.
  3. people who unconsciousness and can not complete questionnaire.
  4. long-term regular use of vitamin or mineral supplements.

Sites / Locations

  • SunYat-sen University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

supplementation of compound nutrients

placebo control

Arm Description

Betaine、(6S)-5-methyltetrahydrofolic acid、vitamin B6、vitamin B12 and zinc are provided as a 800mg tablet. And the tablet is orally taken once a day, four tablets at a time for 12 weeks.

The placebo is an excipient and the color, flavor, shape, taste and weight are same with the tablet of betaine、(6S)-5-methyltetrahydrofolic acid、vitamin B6、vitamin B12 and zinc supplement.

Outcomes

Primary Outcome Measures

levels of homocysteine
At baseline, 4 weeks and 12 weeks, blood samples will be drawn and levels of homocysteine will be tested in two groups.

Secondary Outcome Measures

levels of 5-methyltetrahydrofolic acid, vitamin B6, vitamin B12 and betaine
At baseline, 4 weeks and 12 weeks, blood samples will be drawn and levels of 5-methyltetrahydrofolic acid, vitamin B6, vitamin B12 and betaine will be tested in two groups.
levels of s-adenosyl-methionine and s-adenosyl-homocysteine
At baseline, 4 weeks and 12 weeks, blood samples will be drawn and levels of s-adenosyl-methionine (SAM) and s-adenosyl-homocysteine (SAH) will be tested in two groups.
anthropomorphic measurements and blood biochemical markers
Anthropomorphic measurements such as height, weight, waist circumference, hip circumference, vascular endothelial function, cardiopulmonary function, body composition and so on, and blood biochemical markers such as overnight fasting serum total cholesterol (TC), triglyceride (TG), LDL cholesterol (LDLc), HDL cholesterol (HDLc), fasting blood glucose and so on will be measured.

Full Information

First Posted
October 24, 2018
Last Updated
May 12, 2019
Sponsor
Huilian Zhu
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1. Study Identification

Unique Protocol Identification Number
NCT03720249
Brief Title
Effects of Supplementation of Compound Nutrients on Plasma Homocysteine in Chinese Adults With Hyperhomocysteinemia
Official Title
Supplementation of Compound Nutrients on Plasma Homocysteine in Chinese Adults With Hyperhomocysteinemia: a Randomized Double-blind Control Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2019
Overall Recruitment Status
Unknown status
Study Start Date
May 20, 2019 (Anticipated)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Huilian Zhu

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
The purpose of this study is to determine whether supplementation of compound nutrients,including folic acid, vitamin B6, vitamin B12, betaine and zinc, will decrease the level of plasma homocysteine in Chinese adults with hyperhomocysteinemia.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperhomocysteinemia

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
supplementation of compound nutrients
Arm Type
Experimental
Arm Description
Betaine、(6S)-5-methyltetrahydrofolic acid、vitamin B6、vitamin B12 and zinc are provided as a 800mg tablet. And the tablet is orally taken once a day, four tablets at a time for 12 weeks.
Arm Title
placebo control
Arm Type
Placebo Comparator
Arm Description
The placebo is an excipient and the color, flavor, shape, taste and weight are same with the tablet of betaine、(6S)-5-methyltetrahydrofolic acid、vitamin B6、vitamin B12 and zinc supplement.
Intervention Type
Dietary Supplement
Intervention Name(s)
supplementation of compound nutrients
Other Intervention Name(s)
Betaine、 (6S)-5-methyltetrahydrofolic acid、vitamin B6、vitamin B12 and zinc supplement
Intervention Description
Betaine、 (6S)-5-methyltetrahydrofolic acid、vitamin B6、vitamin B12 and zinc per day orally for 12 weeks.
Intervention Type
Dietary Supplement
Intervention Name(s)
placebo control
Intervention Description
The placebo is an excipient and the color, flavor, shape, taste and weight are same with the tablet of supplement.
Primary Outcome Measure Information:
Title
levels of homocysteine
Description
At baseline, 4 weeks and 12 weeks, blood samples will be drawn and levels of homocysteine will be tested in two groups.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
levels of 5-methyltetrahydrofolic acid, vitamin B6, vitamin B12 and betaine
Description
At baseline, 4 weeks and 12 weeks, blood samples will be drawn and levels of 5-methyltetrahydrofolic acid, vitamin B6, vitamin B12 and betaine will be tested in two groups.
Time Frame
12 weeks
Title
levels of s-adenosyl-methionine and s-adenosyl-homocysteine
Description
At baseline, 4 weeks and 12 weeks, blood samples will be drawn and levels of s-adenosyl-methionine (SAM) and s-adenosyl-homocysteine (SAH) will be tested in two groups.
Time Frame
12 weeks
Title
anthropomorphic measurements and blood biochemical markers
Description
Anthropomorphic measurements such as height, weight, waist circumference, hip circumference, vascular endothelial function, cardiopulmonary function, body composition and so on, and blood biochemical markers such as overnight fasting serum total cholesterol (TC), triglyceride (TG), LDL cholesterol (LDLc), HDL cholesterol (HDLc), fasting blood glucose and so on will be measured.
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: People aged 18-65 years. The level of plasma homocysteine is 15-100μmol/L. Free from products which could decrease plasma homocysteine for at least one month. Willing to participate in the study, consume the test product and perform all measurements. Exclusion Criteria: pregnant or lactating women. severe diseases need to control. people who unconsciousness and can not complete questionnaire. long-term regular use of vitamin or mineral supplements.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Huilian Zhu, professor
Phone
+86 20 87331811
Email
zhuhl@mail.sysu.edu.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Huilian Zhu, professor
Organizational Affiliation
Sun Yat-sen University
Official's Role
Study Chair
Facility Information:
Facility Name
SunYat-sen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510080
Country
China

12. IPD Sharing Statement

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Effects of Supplementation of Compound Nutrients on Plasma Homocysteine in Chinese Adults With Hyperhomocysteinemia

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