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OpenTrials
Completed

NCT Number: NCT02688283

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.

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Key information

Conditions

Glycemic Response; Satiety

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Nutrient cluster

Other

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

Primary outcomes

  1. area under the curve (AUC) for glucose and insulin

    Time frame: 0-4 hours post consumption

Secondary outcomes

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

    Time frame: 0-4 hours post consumption

Sponsors and collaborators

Lead sponsor

PepsiCo Global R&D

Industry

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Feb 23, 2016
Registry last updated
Sep 27, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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