Post-prandial Glycemic Response to Fiber in Healthy Adults

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Glucose, High Blood, Glucose, Low Blood, Meals

Intervention / Treatment
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* Other: resistant starch (high fiber muffin top)
* Other: control (low fiber muffin top)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: High fiber - low fiber<br>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)<br>* Muffin top contained 11 g of fiber per portion<br>Other: control (low fiber muffin top)<br>* Muffin top contained 1 g of fiber per portion<br>|
| Experimental: low fiber - high fiber<br>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)<br>* Muffin top contained 11 g of fiber per portion<br>Other: control (low fiber muffin top)<br>* Muffin top contained 1 g of fiber per portion<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood glucose response | IV and capillary | 0-4 hours after consumption | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood insulin response | IV | 0-4 hours after consumption | 
| Breath hydrogen response | Expired air | 0-24 hours after consumption | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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postprandial glucose insulin