Development of synbiotic Thai custard with sugar substitutes (Monitoring of postprandial blood glucose, insulin, and triglyceride levels)

Phase 1

Completed

• Conditions: Healthy volunteers who have normal levels of glucose and triglycerides.; Glucose response; Postprandial plasma glucose; Insulin response; Postprandial plasma insulin; Triglyceride response; Postprandial serum triglyceride

• Registration Number: TCTR20240528006
• Lead Sponsor: Department of Food Chemistry, Faculty of Pharmacy, Mahidol University

Brief Summary

The intervention can lower postprandial plasma glucose and insulin response by 31.31% and 30.75%, respectively, However, no impact on postprandial serum triglyceride response.

Detailed Description

Not available

Study Timeline

• Study Completion: 2024-02-24
• Study Start: 2024-05-28
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 5

Inclusion Criteria

1. Healthy volunteers
2. Age between 18 to 40 years
3. Body mass index (BMI) between 18.5 - 22.9 kg/m2
4. Fasting blood glucose not more than 100 mg/dL
5. Fasting blood triglyceride not more than 150 mg/dL 6. Not had any major illnesses in the past 3 months

Exclusion Criteria

1. Presentation of chronic diseases such as diabetes mellitus, hypercholesterolemia, liver and kidney disease.
2. Immunocompromised conditions
3. Using medications, herbs, or supplements that could affect nutrient absorption, glucose level, lipid, or carbohydrate metabolism.
4. Allergy to an ingredient in the products (including duck egg, pandanus leaves, coconut sugar mixed with cane sugar, maltitol, luo han guo, coconut milk, inulin, polydextrose, soybean oil, taro, and B. coagulans)
5. Smoking
6. Alcohol users
7. Pregnancy
8. Lactation

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Plasma glucose response 0 - 120 minutes after intake the sample Postprandial plasma glucose by enzymatic colorimetric test (glucose oxidase and peroxidase oxidation)

Secondary Outcome Measures

Name	Time	Method
Serum insulin response 0 - 120 minutes after intake the sample Postprandial serum insulin level by human insulin ELISA kit ,Serum triglyceride response 0 - 240 minutes after intake the sample Postprandial serum triglyceride level by enzymatic method (glycerol phosphate oxidase)