Completed

NCT Number: NCT02692144

Effect of an Optimized Savory Cluster on Glycemic and Insulinemic Responses in Healthy Individuals

This study was to test the hypothesis that an optimized savory cluster (Test-cluster) made through a proprietary baking process combined with slow digestible carbohydrates and fiber will elicit lower postprandial blood glucose and insulin responses than a Control-cluster made from general processing procedure and with typical ingredients commonly used in commercially available snacks or bars: oats, peanuts, and corn syrup. However, since the Test-cluster contains ~30% less available-carbohydrate (24g) than the Control (33g), the postprandial responses elicited by the Test-cluster was also compared with those after a portion of White-bread matched for available-carbohydrate content. On 3 separate days, 25 healthy male or non-pregnant females aged 18-60 yr with BMI between 20 and 35 kg/m² with fasting serum glucose <7.0mmol/L (126 mg/dL) were asked to consume 1 serving (56g) of the Test- or Control-cluster or 47g White Bread and had blood glucose and insulin measured at intervals over the next 4 hr. Each serving of Test-cluster and Control-cluster contained similar amounts of total carbohydrates, protein, fat and energy content. Each serving of Test-cluster and White-bread had equivalent amount of 24g available carbohydrate.

On each test occasion, after subjects were weighed, 2 fasting blood samples were obtained by finger-prick 5min apart and after the 2nd sample, the subject started to consume a test meal. Subjects were asked to consume the entire test meal within 10 min. At the first bite a timer was started and blood samples for were taken for glucose analysis at 10, 20, 30, 40, 50, 60, 90, 120, 180 and 240 min after starting to eat. Additional blood was taken into a separate vial at -5, 0, 20, 40, 60, 90, 120, 180 and 240 min for insulin analysis. Blood samples were obtained from hands warmed with an electric heating pad for 3-5 min prior to each sample. During the 4hr of the test, participants remained seated quietly. After the last blood sample participants were offered a snack and then allowed to leave.

Completed

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Key information

Conditions

Peak Rise of Blood Glucose

Age range

18 year–60 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

Male or non-pregnant females, 18-60 years of age, inclusive
Body mass index (BMI) ≥ 20.0 and < 35 kg/m² at screening (visit 1).
Willing to maintain habitual diet, physical activity pattern, and body weight throughout the trial and to refrain from smoking for 12hr prior to each visit.
Willing to maintain current dietary supplement use throughout the trial. On test days, subject agrees not to take any dietary supplements until dismissal from the GI labs. Failure to comply will result in a rescheduled test visit.
Normal fasting serum glucose (<7.0mmol/L capillary corresponding to whole blood glucose <6.3mmol/L).
Willing to abstain from alcohol consumption and avoid vigorous physical activity for 24 h prior to all test visits.
Absence of health conditions that would prevent fulfillment of study requirements as judged by the Investigator on the basis of medical history.
Understanding the study procedures and willing to provide informed consent to participate in the study and authorization to release relevant protected health information to the study investigator.

Exclusion criteria

Treatment and study plan

Test Cluster

Other

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

Primary outcomes

Peak rise of blood glucose

Time frame: 0-4 hours post consumption

Secondary outcomes

Incremental area under the curve of blood glucose

Time frame: 0-4 hours post consumption
Peak rise of serum insulin

Time frame: 0-4 hours post consumption
Incremental area under the curve of serum insulin

Time frame: 0-4 hours post consumption

Sponsors and collaborators

Lead sponsor

PepsiCo Global R&D

Industry

Registry information

Official study title

Effect of an Optimized Savory Cluster on Glycemic and Insulinemic Responses in Healthy Individuals: A Randomized, Cross-over Study

Important dates

Study start: 2015
Primary completion: 2016
Study completion: 2016
First posted: Feb 25, 2016
Registry last updated: Feb 5, 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.