The Effect on Glycemic Responses and Subjective Ratings of Satiety of a Snack With or Without Ingredients to Slow Carbohydrate Digestion

Study Overview
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Brief Summary
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The objective of this trial is to compare a snack with ingredients (whole grains and dietary fiber) to slow carbohydrate digestion to a similar control snack without such ingredients and evaluate the effect of the snack on glycemic response and subjective satiety. The test product will be compared with a control product as well as white bread in a randomized, controlled, crossover trial including 20 healthy males or females between the ages of 18 and 70 and having a body mass index (BMI) between 25 and 30 kg/m2. Following an overnight fast, participants will be given each of the study products in a random order at least a week apart. Glucose and insulin will be measured before product consumption and over a period of four hours. Visual analog scales to measure subjective satiety will also be administered over a period of four hours.

Official Title
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Randomized, Controlled, Cross-over Study Comparing The Effect on Glycemic Responses and Subjective Ratings of Satiety of a Snack With or Without Ingredients to Slow Carbohydrate Digestion

Conditions
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Glycemic Response; Satiety

Intervention / Treatment
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* Other: Nutrient cluster


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy males or females between the ages of 18 and 70 inclusive No chronic medications other than oral contraceptives Body Mass Index (BMI) between 25 and 30 kg/m2 inclusive. Body weight stable in a 5 kg range in the 3 months prior to study entry Exclusion Criteria: Pregnant or nursing a baby Women with child-bearing potential who are unwilling to use an effective means of contraception during the study which could include abstinence. Adults unable to consent and prisoners

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 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: Test-cluster<br>56g of optimized savory cluster made through a proprietary process with slowly digestible carbohydrates and fiber | Other: Nutrient cluster<br>* Test cluster is an optimized savory cluster made through a proprietary baking process combined with slow digestible carbohydrates and fiber<br>|
| Placebo Comparator: Control-cluster<br>56g of control cluster made from general baking process with typical ingredients commonly used in commercially available energy snacks or bars | Other: Nutrient cluster<br>* Test cluster is an optimized savory cluster made through a proprietary baking process combined with slow digestible carbohydrates and fiber<br>|
| Placebo Comparator: White-bread<br>45g of white bread containing equivalent amount of available carbohydrate in 56g of optimized savory cluster | Other: Nutrient cluster<br>* Test cluster is an optimized savory cluster made through a proprietary baking process combined with slow digestible carbohydrates and fiber<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| area under the curve (AUC) for glucose and insulin |  | 0-4 hours post consumption | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUC for the visual analog scale (VAS) ratings of satiety |  | 0-4 hours post consumption |