NCT03844503

Food Containing Resistant Starch Type 4 and Postprandial Glycemic Response

Food Prototype Containing Resistant Starch Type 4 on Postprandial Glycemic Response in Healthy Adults

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 31 (actual)
• Sponsor: Clinical Nutrition Research Center, Illinois Institute of Technology · Industry
• Sex: All
• Age: 20 Years – 45 Years
• Healthy volunteers: Accepted

Summary

The primary objective of the study is to determine if resistant starch reduces the 2 hour glycemic response as measured by positive incremental area under the blood glucose response curve (Positive iAUC- ignores area below fasting). Secondary endpoints include insulin iAUC, glucose and insulin net incremental AUC (net iAUC), time point of peak rise (T max) of glucose and insulin, and glucose and insulin concentrations at each time point (C max).

Detailed description

This is a single-center randomized, single-blinded, cross-over design study to allow for three acute evaluations of 2 hr postprandial glucose in response to 3 cereal bars containing different amounts of resistant starch. The study will evaluate acute glucose and insulin response in healthy men and women aged 20-45 years. The trial will initiate with record collection to assess background general health (screening visit) and dietary intake followed by counseling to follow a relatively low polyphenolic beverages/foods diet, and high fiber containing food (particularly fermentable) which will commence at least 3 days before randomization (washout) and continue for the duration of the study. After 3-day washout period, subjects will be randomized to treatment order within Phase (Treatment cereal bars A, B, C). Glucose and insulin responses following the consumption of cereal bars will be determined by blood collections via venous catheter. Blood samples (3 ml of blood) will be collected at -5 min (before the cereal bar consumption) and 15, 30, 45, 60, 90, and 120 min after consuming bars for assessment in changes in glucose and insulin concentrations in the plasma. The primary endpoint is glucose positive incremental area under the curve (positive iAUC- ignores area below fasting) among the three tests bars. Secondary endpoints are glucose peak, insulin positive iAUC and peak and glucose and insulin net incremental AUC (net iAUC). Adverse events also will be collected and frequency tabulated.

Conditions

• Healthy

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Cereal Bar no fiber	Cereal Bar no fiber
DIETARY_SUPPLEMENT	Cereal bar with 10 g fiber	Cereal bar with 10 g fiber
DIETARY_SUPPLEMENT	Cereal bar with 20 g fiber	Cereal bar with 20 g fiber

Timeline

• Start date: 2019-02-11
• Primary completion: 2019-10-25
• Completion: 2019-10-25
• First posted: 2019-02-18
• Last updated: 2020-07-14

Locations

1 site across 1 country: United States