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

PepsiCo

Status: Completed

Conditions: Glycemic Response; Satiety

Treatments: Other: Nutrient cluster

Study type: Interventional

Funder types: Industry

Identifiers

NCT02688283

PEP-1512

Details and patient eligibility

About

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.

Enrollment: 20 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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20 participants in 3 patient groups, including a placebo group

Test-cluster

Experimental group

Description:

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

Treatment:

Other: Nutrient cluster

Control-cluster

Placebo Comparator group

Description:

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

Treatment:

Other: Nutrient cluster

White-bread

Placebo Comparator group

Description:

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

Treatment:

Other: Nutrient cluster