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

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

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.

Study Overview

• Status: Completed
• Conditions: Glycemic Response; Satiety
• Intervention / Treatment: Other: Nutrient cluster

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Test-cluster; 56g of optimized savory cluster made through a proprietary process with slowly digestible carbohydrates and fiber	Other: Nutrient cluster; Test cluster is an optimized savory cluster made through a proprietary baking process combined with slow digestible carbohydrates and fiber
Placebo Comparator: Control-cluster; 56g of control cluster made from general baking process with typical ingredients commonly used in commercially available energy snacks or bars	Other: Nutrient cluster; Test cluster is an optimized savory cluster made through a proprietary baking process combined with slow digestible carbohydrates and fiber
Placebo Comparator: White-bread; 45g of white bread containing equivalent amount of available carbohydrate in 56g of optimized savory cluster	Other: Nutrient cluster; Test cluster is an optimized savory cluster made through a proprietary baking process combined with slow digestible carbohydrates and fiber

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: PepsiCo Global R&D
• Investigators: Principal Investigator: Frank Greenway, MD, Pennington Biomedical Research Center

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2015
• Primary Completion (Actual): February 1, 2016
• Study Completion (Actual): April 1, 2016

Study Registration Dates

• First Submitted: February 17, 2016
• First Submitted That Met QC Criteria: February 17, 2016
• First Posted (Estimate): February 23, 2016

Study Record Updates

• Last Update Posted (Actual): September 27, 2018
• Last Update Submitted That Met QC Criteria: September 25, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: PEP-1512

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No