Post-prandial Glycemic Response to Fiber in Healthy Adults

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

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.

Study Overview

• Status: Completed
• Conditions: Glucose, Low Blood; Glucose, High Blood; Meals
• Intervention / Treatment: Other: resistant starch (high fiber muffin top); Other: control (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 Type: Interventional
• Enrollment (Actual): 28
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: High fiber - low fiber; Treatment order described in arm title, resistant starch (high fiber muffin top) - conventional flour (low fiber muffin top)	Other: resistant starch (high fiber muffin top); Muffin top contained 11 g of fiber per portion; Other: control (low fiber muffin top); Muffin top contained 1 g of fiber per portion
Experimental: low fiber - high fiber; Treatment order described in arm title, conventional flour (low fiber muffin top)- resistant starch (high fiber muffin top)	Other: resistant starch (high fiber muffin top); Muffin top contained 11 g of fiber per portion; Other: control (low fiber muffin top); Muffin top contained 1 g of fiber per portion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood glucose response	IV and capillary	0-4 hours after consumption

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood insulin response	IV	0-4 hours after consumption
Breath hydrogen response	Expired air	0-24 hours after consumption

Collaborators and Investigators

• Sponsor: Ingredion Incorporated
• Collaborators: KGK Science Inc.
• Investigators: Principal Investigator: Tetyana Pelipyagina, MD, KGK Synergize

Publications and helpful links

General Publications

• Stewart ML, Zimmer JP. Postprandial glucose and insulin response to a high-fiber muffin top containing resistant starch type 4 in healthy adults: a double-blind, randomized, controlled trial. Nutrition. 2018 Sep;53:59-63. doi: 10.1016/j.nut.2018.01.002. Epub 2018 Feb 13.

Study record dates

Study Major Dates

• Study Start (Actual): March 31, 2016
• Primary Completion (Actual): October 31, 2016
• Study Completion (Actual): October 31, 2016

Study Registration Dates

• First Submitted: August 14, 2017
• First Submitted That Met QC Criteria: August 14, 2017
• First Posted (Actual): August 17, 2017

Study Record Updates

• Last Update Posted (Actual): August 21, 2017
• Last Update Submitted That Met QC Criteria: August 16, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Keywords: postprandial glucose insulin
• Other Study ID Numbers: 16AFHI

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No