Post-prandial Glucose and Insulin Response to High-fiber Muffin Top Containing Resistant Starch in Healthy Adults
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Ingredion Incorporated
- Enrollment
- 28
- Primary Endpoint
- Blood glucose response
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Basic Science
- 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.
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- 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;
- •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
Arms & Interventions
High fiber - low fiber
Treatment order described in arm title, resistant starch (high fiber muffin top) - conventional flour (low fiber muffin top)
Intervention: resistant starch (high fiber muffin top) (Other)
High fiber - low fiber
Treatment order described in arm title, resistant starch (high fiber muffin top) - conventional flour (low fiber muffin top)
Intervention: control (low fiber muffin top) (Other)
low fiber - high fiber
Treatment order described in arm title, conventional flour (low fiber muffin top)- resistant starch (high fiber muffin top)
Intervention: resistant starch (high fiber muffin top) (Other)
low fiber - high fiber
Treatment order described in arm title, conventional flour (low fiber muffin top)- resistant starch (high fiber muffin top)
Intervention: control (low fiber muffin top) (Other)
Outcomes
Primary Outcomes
Blood glucose response
Time Frame: 0-4 hours after consumption
IV and capillary
Secondary Outcomes
- Blood insulin response(0-4 hours after consumption)
- Breath hydrogen response(0-24 hours after consumption)