Pilot study for the consumption of food product made from KluayNamwa(Musa sapientum L. ABB cv.) on safety and effect to control glycemic index and lipid profile in healthy volunteer

Phase 1

• Conditions: healthy conditions; KluayNamwa; glycemic index; lipid profile; fasting blood glucose

• Registration Number: TCTR20200128002
• Lead Sponsor: ational Research council of Thailand

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2020-01-28
• Study Completion: 2021-07-01
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Enrolling by invitation
• Sex: Female
• Target Recruitment: 40

Inclusion Criteria

1. Healthy women aged between 35-60 years old
2. Body mass index (BMI) > 23 kg/m2
3. Without being pregnant or breastfeeding

Exclusion Criteria

1. Diagnosed with cardiovascular diseases, respiratory diseases, neuropsychological diseases, head injury, diabetes mellitus, liver disease, cancer, autoimmune diseases and hematological disorder
2. Chronic diseases include: liver, kidney, heart and hematological disorder
3. Using supplements or herbs or drugs at least 1 months before participating in this study
4. Volunteers who require supplements or drugs that effect on body weight, blood sugar and lipid control
5. Smoking more than 10 pieces/day
6. Alcohol addiction or using addictive substances
7. Regular excercise more than 3 times/week
8. Blood pressure > 140/90 mmHg

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Fasting blood glucose and lipid profiles 2 hours for single dose effect laboratory,Fasting blood glucose 3 months glucometer, photometric method,Plasma lipid profiles 3 months laboratory

Secondary Outcome Measures

Name	Time	Method
HbA1c 3 months laboratory,The changes of hematological and clinical chemistry parameters 3 months laboratory,Body Mass Index 3 months equipment ,Electrocardiogram 3 months electrocardiograph,Safety evaluation and side effect 3 months Questionaires,Homeostasis Model Assessment Insulin Resistance (HOMA-IR) 3 months laboratory,Stool examination(total Lactic acid bacteria, lactobacillus spp., bifidobacterium spp., short chain) 3 months laboratory,Body Composition 3 months equipment