Safety evaluation and effect of consumption of combined extract of Ginger and Mulberry to reduce the risk of metabolic disorders

Phase 1

Completed

• Conditions: Healthy conditions; Ginger; Mulberry; metabolic disorders; working memory; cognitive processing

• Registration Number: TCTR20210616006
• Lead Sponsor: Program Management Unit Competitiveness (PMUC)

Brief Summary

Consuming the capsule containing ginger and mulberry extract can help the risk of metabolic disorders.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-06-16
• Study Completion: 2023-04-19
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 75

Inclusion Criteria

1. Aged between 35-60 years old
2.Body Mass Index (BMI) between 25-29.99 kg/m2
3.Blood pressure less than 140/90 mm Hg and Fasting Blood Sugar (FBS) after fasts for 8 hours less than 126 mg/d

Exclusion Criteria

1.Volunteers who have been diagnosed with one of the following; cardiovascular diseases, respiratory diseases, neuropsychological diseases, liver disease (AST more than 64 U/L, ALT more than 50 U/L), Kidney disease (estimate GFR less than 90 ml/min), autoimmune disease, hematological disorder, and cancer
2.Volunteers who require supplements or any drug that affect the nervous system by order of the doctor before trial
3.Volunteers who use supplements or any drug that affect the body weight, glucose, and lipid level before trial
4.Smoking more than 10 pieces/ day
5.Drinking alcohol more than 5 times/ day
6.Volunteers who participate in other projects
7. Pregnancy or lactating women

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Metabolic parameters include Homeostasis Model Assessment Insulin Resistance (HOMA-IR) index, Atherosclerosis index (AI Index) , Atherogenic index of plasma (AIP), and Oxidized LDL 8 weeks Laboratory

Secondary Outcome Measures

Name	Time	Method
The changes of hematological and clinical chemistry parameters 8 weeks Laboratory, Acetylcholinesterase and Monoamine oxidase enzyme (MAOA and MAOB) 8 weeks Laboratory,Oxidative stress markers include Malondialdehyde (MDA), Superoxide dismutase (SOD), Catalase (CAT), and Glutathione peroxidase (GSH-Px) 8 weeks Laboratory,Angiotensin converting enzyme (ACE) 8 weeks Elisa method,Advanced glycation end products (AGEs) 8 weeks Elisa method,Homocysteine 8 weeks Laboratory,Inflammatory markers include C-Reactive protein (CRP), IL-1 , and IL-6 8 weeks Elisa method,Body Composition, Body Mass Index (BMI), and Anthropometry 8 weeks Equipment,The changes of electrocardiogram 8 weeks Electrocardiography,Physical fitness 8 weeks Equipment