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

NCT ID: NCT02688283

Last Updated: 2018-09-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-11-30
• Study Completion Date: 2016-04-30

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.

Conditions

Glycemic Response; Satiety

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Study Groups

Test-cluster

56g of optimized savory cluster made through a proprietary process with slowly digestible carbohydrates and fiber

Group Type: EXPERIMENTAL

Nutrient cluster

Intervention Type: OTHER

Test cluster is an optimized savory cluster made through a proprietary baking process combined with slow digestible carbohydrates and fiber

Control-cluster

56g of control cluster made from general baking process with typical ingredients commonly used in commercially available energy snacks or bars

Group Type: PLACEBO_COMPARATOR

Nutrient cluster

Intervention Type: OTHER

Test cluster is an optimized savory cluster made through a proprietary baking process combined with slow digestible carbohydrates and fiber

White-bread

45g of white bread containing equivalent amount of available carbohydrate in 56g of optimized savory cluster

Group Type: PLACEBO_COMPARATOR

Nutrient cluster

Intervention Type: OTHER

Test cluster is an optimized savory cluster made through a proprietary baking process combined with slow digestible carbohydrates and fiber

Interventions

Nutrient cluster

Test cluster is an optimized savory cluster made through a proprietary baking process combined with slow digestible carbohydrates and fiber

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

PepsiCo Global R&D

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Frank Greenway, MD

Role: PRINCIPAL_INVESTIGATOR

Pennington Biomedical Research Center

Other Identifiers

PEP-1512

Identifier Type: -

Identifier Source: org_study_id