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Clinical Trials/NCT03252704
NCT03252704
Completed
Not Applicable

Post-prandial Glucose and Insulin Response to High-fiber Muffin Top Containing Resistant Starch in Healthy Adults

Ingredion Incorporated0 sites28 target enrollmentMarch 31, 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Glucose, High Blood
Sponsor
Ingredion Incorporated
Enrollment
28
Primary Endpoint
Blood glucose response
Status
Completed
Last Updated
8 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 31, 2016
End Date
October 31, 2016
Last Updated
8 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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;
  • use of medical marijuana;
  • alcohol or drug abuse treatment in past 12 months;
  • allergy or sensitivity to study products;

Outcomes

Primary Outcomes

Blood glucose response

Time Frame: 0-4 hours after consumption

IV and capillary

Secondary Outcomes

  • Blood insulin response(0-4 hours after consumption)
  • Breath hydrogen response(0-24 hours after consumption)

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