Post-prandial Glycemic Response to Fiber in Healthy Adults

Ingredion

Status: Completed

Conditions: Meals; Glucose, High Blood; Glucose, Low Blood

Treatments: Other: control (low fiber muffin top); Other: resistant starch (high fiber muffin top)

Study type: Interventional

Funder types: Industry

Identifiers

NCT03252704

16AFHI

Details and patient eligibility

About

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.

Full 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.

Enrollment: 28 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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28 participants in 2 patient groups

High fiber - low fiber

Experimental group

Description:

Treatment order described in arm title, resistant starch (high fiber muffin top) - conventional flour (low fiber muffin top)

Treatment:

Other: control (low fiber muffin top)

Other: resistant starch (high fiber muffin top)

low fiber - high fiber

Experimental group

Description:

Treatment order described in arm title, conventional flour (low fiber muffin top)- resistant starch (high fiber muffin top)

Treatment:

Other: control (low fiber muffin top)

Other: resistant starch (high fiber muffin top)