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

Supplementation of Compound Nutrients on Plasma Homocysteine in Chinese Adults With Hyperhomocysteinemia: a Randomized Double-blind Control Trial

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Hyperhomocysteinemia
• Intervention / Treatment: Dietary supplement: supplementation of compound nutrients; Dietary supplement: placebo control

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Huilian Zhu, professor; Phone Number: +86 20 87331811; Email: zhuhl@mail.sysu.edu.cn

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510080
      • SunYat-sen University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: supplementation of compound nutrients; 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.	Dietary supplement: supplementation of compound nutrients; Betaine、 (6S)-5-methyltetrahydrofolic acid、vitamin B6、vitamin B12 and zinc per day orally for 12 weeks.; Other Names: Betaine、 (6S)-5-methyltetrahydrofolic acid、vitamin B6、vitamin B12 and zinc supplement
Placebo Comparator: placebo control; 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.	Dietary supplement: placebo control; The placebo is an excipient and the color, flavor, shape, taste and weight are same with the tablet of supplement.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	12 weeks
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.	12 weeks
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.	12 weeks

Collaborators and Investigators

• Sponsor: Huilian Zhu
• Investigators: Study Chair: Huilian Zhu, professor, Sun Yat-sen University

Study record dates

Study Major Dates

• Study Start (Anticipated): May 20, 2019
• Primary Completion (Anticipated): December 31, 2022
• Study Completion (Anticipated): December 31, 2022

Study Registration Dates

• First Submitted: October 24, 2018
• First Submitted That Met QC Criteria: October 24, 2018
• First Posted (Actual): October 25, 2018

Study Record Updates

• Last Update Posted (Actual): May 14, 2019
• Last Update Submitted That Met QC Criteria: May 12, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Nutrition Disorders; Genetic Diseases, Inborn; Avitaminosis; Deficiency Diseases; Malnutrition; Metabolism, Inborn Errors; Malabsorption Syndromes; Amino Acid Metabolism, Inborn Errors; Vitamin B Deficiency; Hyperhomocysteinemia; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Antimetabolites; Gastrointestinal Agents; Micronutrients; Hypolipidemic Agents; Lipid Regulating Agents; Lipotropic Agents; Vitamins; Vitamin B 12; Vitamin B Complex; Vitamin B 6; Betaine
• Other Study ID Numbers: MN-2018-10

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No