NCT02225951

Meal Tolerance Trial in Pregnant Women Diagnosed With Gestational Diabetes Mellitus.

A Randomised, Controlled, Open-label Trial to Investigate the Effect of a New Nutritional Supplement on Postprandial Glucose Response in Women Diagnosed With Gestational Diabetes Mellitus.

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 3 (actual)
• Sponsor: Danone Asia Pacific Holdings Pte, Ltd. · Industry
• Sex: All
• Age: 18 Years – 40 Years
• Healthy volunteers: Not accepted

Summary

This study is initiated to investigate the effect of a nutritional product on the 3-hr postprandial glucose response compared to a control standard breakfast at baseline and after 4 weeks of intervention.

Detailed description

The primary objective of the study is to investigate the effect of study product on the 3-hour postprandial glucose response compared to a controlled standard breakfast at baseline and after 4 weeks of intervention. Secondary objectives include investigation on the effect of the product compared to a control standard breakfast to the 3-hr postprandial insulin response, postprandial peak and delta peak concentration of glucose and insulin, fasting concentration of glucose and insulin, and insulin resistance as calculated by the HOMA index. The study also aims to measure compliance, study product intake and appreciation, safety and tolerance to study product, as well as satiety, daily energy and nutrient intake.

Conditions

• Gestational Diabetes Mellitus in Pregnancy

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Nutritional product
OTHER	Standard breakfast according to ADA recommendations

Timeline

• Start date: 2014-07-01
• Primary completion: 2014-09-01
• Completion: 2014-09-01
• First posted: 2014-08-26
• Last updated: 2017-09-07

Locations

1 site across 1 country: Singapore