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

Not Applicable

Completed

• Conditions: Glycemic Response; Satiety
• Interventions: Other: Nutrient cluster

• Registration Number: NCT02688283
• Lead Sponsor: PepsiCo Global R&D

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-11
• Primary Completion: 2016-02
• Study First Submitted: 2016-02-17
• Study First Submitted QC: 2016-02-17
• Study First Posted: 2016-02-23
• Study Completion: 2016-04
• Status Verified: 2018-09
• Last Update Submitted: 2018-09-25
• Last Update Posted: 2018-09-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

1. Healthy males or females between the ages of 18 and 70 inclusive
2. No chronic medications other than oral contraceptives
3. Body Mass Index (BMI) between 25 and 30 kg/m2 inclusive.
4. Body weight stable in a 5 kg range in the 3 months prior to study entry

Exclusion Criteria

1. Pregnant or nursing a baby
2. Women with child-bearing potential who are unwilling to use an effective means of contraception during the study which could include abstinence.
3. Adults unable to consent and prisoners

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
White-bread	Nutrient cluster	45g of white bread containing equivalent amount of available carbohydrate in 56g of optimized savory cluster
Test-cluster	Nutrient cluster	56g of optimized savory cluster made through a proprietary process with slowly digestible carbohydrates and fiber
Control-cluster	Nutrient cluster	56g of control cluster made from general baking process with typical ingredients commonly used in commercially available energy snacks or bars

Primary Outcome Measures

Name	Time	Method
area under the curve (AUC) for glucose and insulin	0-4 hours post consumption

Secondary Outcome Measures

Name	Time	Method
AUC for the visual analog scale (VAS) ratings of satiety	0-4 hours post consumption