Postprandial Glycemic Response to Polyphenol-fortified Snack Bars

NCT02763020 | Completed

• 1 other identifier: 15-28-HC
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Consuming plant chemicals (e.g., polyphenols) may have beneficial effects on human health that, if confirmed, may warrant inclusion in combat rations. Ration developers would like to determine whether the fortification of a high sugar food item with a polyphenol-rich freeze-dried fruit and/or a fruit extract improves blood sugar response and promotes other positive physiological changes (e.g., satiety) in a dose-response manner. This study will test four different types of snack bar with various polyphenol doses, and compare blood response to a snack bar without polyphenols.

Conditions

Blood Sugar Response

Keywords

high glycemic index, polyphenols, blood glucose, satiety

Outcome Measures

Primary Outcomes (1)

• blood glucose concentrations

  fasting and post-prandial (every 15 minutes for the first hour and every half hour for the last two hours)

Secondary Outcomes (2)

• gut hormones

  fasting and post-prandial (every 15 minutes for the first hour and every half hour for the last two hours)

• blood concentration of phenolic acids

  fasting, post-prandial 60 minutes, 120 minutes and 180 minutes

Study Arms (5)

Food bar without fruit

PLACEBO COMPARATOR

snack bar without fruit

Other: placebo

Food bar with cranberry extract (0.5%)

EXPERIMENTAL

Snack bar with cranberry extract (0.5% total weight)

Other: Fruit extracts high in polyphenols

Food bar with cranberry extract (1.0%)

EXPERIMENTAL

Snack bar with cranberry extract (1.0% total weight)

Other: Fruit extracts high in polyphenols

Food bar w/ dried black raspberry (10%)

EXPERIMENTAL

Snack bar with freeze-dried black raspberry(10% total weight)

Other: Fruit extracts high in polyphenols

Food bar w/ dried black raspberry (20%)

EXPERIMENTAL

Snack bar with freeze-dried black raspberry (20% total weight)

Other: Fruit extracts high in polyphenols

Interventions

Fruit extracts high in polyphenols OTHER

Food bar w/ dried black raspberry (10%); Food bar w/ dried black raspberry (20%); Food bar with cranberry extract (0.5%); Food bar with cranberry extract (1.0%)

placebo OTHER

Food bar without fruit

Eligibility Criteria

• Age: 18 Years - 39 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Soldiers who are stationed with USARIEM, NSRDEC or the U.S. Army Natick Soldier Center pool of military participants, or any civilians will be invited to participate in this study.

You may not qualify if:

• Potential participants will be excluded from participation if they: are under the age of 18 or over the age of 39 (i.e. insulin sensitivity declines with age, hence the upper age limit of 39 years); have a pre-existing liver disease, history of alcoholism or typically consume more than 4 alcoholic beverages daily or 6 on one occasion more than once a month within the past 6 months; have impaired glucose metabolism due to diabetes, pre-diabetes, galactosemia, hereditary fructose intolerance or glycogen storage disease; have thyroid disease; have a bleeding disorder (e.g., von Willebrand Disease, hemophilia) or are being treated with medication that will impair blood clotting; have a history of GI-related conditions that may impact glucose absorption (e.g., Crohn's disease, ulcerative colitis, Celiac's disease or gluten sensitivity, bariatric surgery or gastroparesis); are taking any medications affecting carbohydrate metabolism (e.g., insulin or oral diabetes medications); and/or, have an allergy or aversion to any of the test foods.

Sponsors & Collaborators

• United States Army Research Institute of Environmental Medicine: lead

Study Sites (1)

USARIEM

Natick, Massachusetts, 01760, United States

Location

MeSH Terms

Interventions

Polyphenols

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Tracey J Smith, PhD

  United States Army Research Institute of Environmental Medicine

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: May 3, 2016
• First Posted: May 5, 2016
• Study Start: March 1, 2016
• Primary Completion: October 1, 2017
• Study Completion: November 1, 2017
• Last Updated: December 12, 2017

Record last verified: 2017-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)