Post-prandial Glycemic Response to Fiber in Healthy Adults

Glucose, High Blood Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03252704
• Other study ID #: 16AFHI
• Status: Completed
• Phase: N/A
• First received: August 14, 2017
• Last updated: August 16, 2017
• Start date: March 31, 2016
• Est. completion date: October 31, 2016

Study information

• Verified date: August 2017
• Source: Ingredion Incorporated
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: October 31, 2016
• Est. primary completion date: October 31, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Glucose, High Blood
• Glucose, Low Blood
• Hyperglycemia
• Hypoglycemia
• Meals

Intervention

Other:
• resistant starch (high fiber muffin top)
Muffin top contained 11 g of fiber per portion
• control (low fiber muffin top)
Muffin top contained 1 g of fiber per portion

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Ingredion Incorporated	KGK Synergize Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood glucose response	IV and capillary	0-4 hours after consumption
Secondary	Blood insulin response	IV	0-4 hours after consumption
Secondary	Breath hydrogen response	Expired air	0-24 hours after consumption