NCT02615327

Effect of Fiber on Glycemic Index

Verifying Fibers Meet Regulatory Definitions for Nutrition Facts Labeling: A Randomized, Controlled Trial Evaluating Polydextrose

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Clinical Nutrition Research Center, Illinois Institute of Technology · Industry
• Sex: All
• Age: 20 Years – 55 Years
• Healthy volunteers: Accepted

Summary

Primary objective is to investigate the effect of polydextrose on postprandial glucose concentrations in healthy adults when added to a food product. Secondary objective is to assess gastrointestinal tolerance and acute bowel changes.

Detailed description

This study is a randomized, 4-arm, single-blinded, controlled, cross-over trial design focused on determining the health benefits associated with Polydextrose intake. A planned sample size of 40 will be enrolled into the study. This study will require one initial screening visit and 4 weekly study visits. This study will take approximately 4 weeks per subject to complete. The initial screening visit will provide subject with the informed consent document and determine subject eligibility through anthropometric measurements, vital signs, fasting blood glucose test (finger prick), and completion of a survey relate to general eating, health, and exercise habits. If willing and eligible to participate, subjects will be invited to participate in the study for 4 study days. Subjects will be instructed to maintain their usual diet pattern and physical activity throughout study duration. A dinner meal will be provided the day before the study visit to control the second meal effect from the food and beverage intake of the night before the study visit. Subject will arrive at the center in a fasted state for at least 10 hours, well hydrated and rested. Each study visit will require blood draws throughout the visit. After evaluation of subject's health status (via anthropometric, vital sign and blood glucose measurements and in-person interview), a Licensed health Care Professional will place a catheter in subject's arm for the purpose of multiple blood sample collections and take the initial blood draw in the fasting state. Subjects will be randomized to receive a placebo or treatment beverage based on randomized treatment sequences for 4 study visits. The sequences of receiving the beverage treatments at each visit will be randomly assigned to one of sequences. Each study visit will involve with blood samples collection at time points 0 (fasting), 0.5, 1, 2, 3 hour (h) for assessment of change in plasma glucose and insulin concentrations.

Conditions

• Healthy

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	8 g Polydextrose	8g of Polydextrose
DIETARY_SUPPLEMENT	12 g Polydextrose	12 g of Polydextrose
DIETARY_SUPPLEMENT	16 g Polydextrose	16 g of Polydextrose
DIETARY_SUPPLEMENT	Placebo	0 g of Polydextrose

Timeline

• Start date: 2015-11-01
• Primary completion: 2017-02-22
• Completion: 2018-12-19
• First posted: 2015-11-26
• Last updated: 2021-01-27

Locations

1 site across 1 country: United States