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

NCT02688283 | Completed

• 1 other identifier: PEP-1512
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• area under the curve (AUC) for glucose and insulin

  0-4 hours post consumption

Secondary Outcomes (1)

• AUC for the visual analog scale (VAS) ratings of satiety

  0-4 hours post consumption

Study Arms (3)

Test-cluster

EXPERIMENTAL

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

Other: Nutrient cluster

Control-cluster

PLACEBO COMPARATOR

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

Other: Nutrient cluster

White-bread

PLACEBO COMPARATOR

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

Other: Nutrient cluster

Interventions

Nutrient cluster OTHER

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

Control-cluster; Test-cluster; White-bread

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• PepsiCo Global R&D: lead

Study Officials

• Frank Greenway, MD

  Pennington Biomedical Research Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 17, 2016
• First Posted: February 23, 2016
• Study Start: November 1, 2015
• Primary Completion: February 1, 2016
• Study Completion: April 1, 2016
• Last Updated: September 27, 2018

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will not share