Post-prandial Glycemic Response to Fiber in Healthy Adults

• Sponsor: Ingredion Incorporated (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03252704
• Collaborator: KGK Science Inc. (Industry)
• Enrollment: 28
• Arms: 2
• Actual Duration (Months): 7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Glucose, High Blood; Glucose, Low Blood; Meals	Other: resistant starch (high fiber muffin top); Other: control (low fiber muffin top)	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 28 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Double (Participant, Investigator)
• Masking Description: Study products were concealed in opaque foil envelopes. The treatments were identified by alphanumeric code. The subjects and investigators did not know the identity of the treatments.
• Primary Purpose: Basic Science
• Official Title: Post-prandial Glucose and Insulin Response to High-fiber Muffin Top Containing Resistant Starch in Healthy Adults
• Actual Study Start Date: Mar 31, 2016
• Actual Primary Completion Date: Oct 31, 2016
• Actual Study Completion Date: Oct 31, 2016

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Blood glucose response [0-4 hours after consumption]

   IV and capillary

Secondary Outcome Measures

1. Blood insulin response [0-4 hours after consumption]

   IV

2. Breath hydrogen response [0-24 hours after consumption]

   Expired air

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Ingredion Incorporated
• KGK Science Inc.

Investigators

• Principal Investigator: Tetyana Pelipyagina, MD, KGK Synergize

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Ingredion Incorporated
• ClinicalTrials.gov Identifier: NCT03252704
• Other Study ID Numbers: 16AFHI
• First Posted: Aug 17, 2017
• Last Update Posted: Aug 21, 2017
• Last Verified: Aug 1, 2017

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Ingredion Incorporated: postprandial glucose insulin

Study Results

No Results Posted as of Aug 21, 2017