Post-prandial Glycemic Response to Fiber in Healthy Adults

Not Applicable

Completed

• Conditions: Glucose, Low Blood; Glucose, High Blood; Meals
• Interventions: Other: resistant starch (high fiber muffin top); Other: control (low fiber muffin top)

• Registration Number: NCT03252704
• Lead Sponsor: Ingredion Incorporated

Brief Summary

This randomized, double-blind, comparator controlled trial evaluated the blood glucose and insulin responses in healthy adults, after consuming a high fiber or low fiber muffin top.

Detailed Description

The fiber administered in this trial is a resistant starch type 4 derived from high-amylose maize starch. This product is high in dietary fiber (70% total dietary fiber (TDF), AOAC 2009.01 method) and can be used in a variety of bakery applications. The objective of this study was to evaluate the post-prandial blood glucose and insulin responses of healthy adults (n=28) after consuming a muffin top made with resistant starch or control muffin top, in a randomized, double-blind, crossover study. The muffin tops were matched for total weight, total carbohydrate, sugars, protein, and fat. During each 24-hour study period, subjects consumed a standard evening meal, fasted for 12 hours, and arrived at the study clinic the following morning. Serum glucose, serum insulin, and capillary glucose were measured after muffin top consumption. The subjects completed a seven day washout between treatments.

Study Timeline

• Study Start: 2016-03-31
• Primary Completion: 2016-10-31
• Study Completion: 2016-10-31
• Status Verified: 2017-08
• Study First Submitted: 2017-08-14
• Study First Submitted QC: 2017-08-14
• Last Update Submitted: 2017-08-16
• Study First Posted: 2017-08-17
• Last Update Posted: 2017-08-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

Inclusion Criteria

• 18 years of age or older,
• BMI 18.0-29.9 kg/m2,
• fasting glucose ≤ 6.0 mmol/L;
• if female, not of childbearing potential (e.g. taking oral contraceptives, past hysterectomy)

Exclusion Criteria

• diagnosed metabolic or chronic diseases (e.g. type-2 diabetes);
• cancer diagnosis or treatment within 5 years;
• gastrointestinal problems;
• bowel cleansing during prior week;
• current medications to control blood glucose;
• current medications to control blood cholesterol ;
• current medications to control blood pressure;
• smoker;
• use of medical marijuana;
• alcohol or drug abuse treatment in past 12 months;
• allergy or sensitivity to study products;
• blood donation in prior 2 months;
• if female, currently pregnant, currently breastfeeding, or planning to become pregnant

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
low fiber - high fiber	resistant starch (high fiber muffin top)	Treatment order described in arm title, conventional flour (low fiber muffin top)- resistant starch (high fiber muffin top)
High fiber - low fiber	resistant starch (high fiber muffin top)	Treatment order described in arm title, resistant starch (high fiber muffin top) - conventional flour (low fiber muffin top)
High fiber - low fiber	control (low fiber muffin top)	Treatment order described in arm title, resistant starch (high fiber muffin top) - conventional flour (low fiber muffin top)
low fiber - high fiber	control (low fiber muffin top)	Treatment order described in arm title, conventional flour (low fiber muffin top)- resistant starch (high fiber muffin top)

Primary Outcome Measures

Name	Time	Method
Blood glucose response	0-4 hours after consumption	IV and capillary

Secondary Outcome Measures

Name	Time	Method
Blood insulin response	0-4 hours after consumption	IV
Breath hydrogen response	0-24 hours after consumption	Expired air