Clinical trial NCT03252704: Post-prandial Glycemic Response to Fiber in Healthy Adults
Official title: Post-prandial Glucose and Insulin Response to High-fiber Muffin Top Containing Resistant Starch in Healthy Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Glucose, High Blood
Glucose, Low Blood
Meals
Keywords: postprandial glucose insulin
Lead sponsor: Ingredion Incorporated
Sponsor class: INDUSTRY
Collaborators: name: KGK Science Inc.
First posted: 2017-08-17
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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.

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;
* 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

Primary outcomes:
measure: Blood glucose response
timeFrame: 0-4 hours after consumption
Secondary outcomes:
measure: Blood insulin response
timeFrame: 0-4 hours after consumption
measure: Breath hydrogen response
timeFrame: 0-24 hours after consumption
Other outcomes:
Locations:
Study officials:
affiliation: KGK Synergize
name: Tetyana Pelipyagina, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.