NCT03409484

Brief Summary

Assess the impact of 100% grape juice on postprandial glycemic response and subsequent appetite, food intake and cognitive function.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 18, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 24, 2018

Completed
9 months until next milestone

Study Start

First participant enrolled

October 10, 2018

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 28, 2019

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 20, 2019

Completed
Last Updated

November 5, 2020

Status Verified

August 1, 2019

Enrollment Period

6 months

First QC Date

January 18, 2018

Last Update Submit

November 4, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • Change in blood glucose over 24 hours

    samples taken every 5 minutes for 24 hours by a continuous glucose monitor

    24 hours

Secondary Outcomes (1)

  • Appetite

    24 hours

Study Arms (3)

Concord Grape Juice

ACTIVE COMPARATOR

100% Concord Grape Juice

Other: Concord Grape Juice

Low flavonoid low essence beverage

SHAM COMPARATOR

Low flavonoid low essence beverage

Other: Low flavoniod low essence beverage

Low flavonoid beverage

SHAM COMPARATOR

Low flavonoid beverage

Other: Low flavonoid beverage

Interventions

Concord Grape Juice

Concord Grape Juice

Low flavoniod low essence beverage

Low flavonoid low essence beverage

Low flavonoid beverage

Low flavonoid beverage

Eligibility Criteria

Age25 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • BMI between 25.0-34.9 kg/m2
  • Willingness to eat all test foods
  • Low consumer of tea and coffee, willingness to refrain from both during the 48 hours prior to test days and on the test day.
  • Fasting blood glucose below 6.1mmol/l via capillary finger-stick blood sample using a SureStep glucometer (Lifescan, Milpitas, CA)

You may not qualify if:

  • Taking medications known to affect glycemia, lipid metabolism or appetite
  • Body weight fluctuation of \>5kg in the past 3 months
  • Taking vitamin or other supplements
  • Smokers
  • Acute or Chronic disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Purdue University

West Lafayette, Indiana, 47909, United States

Location

Related Publications (1)

  • Coelho OGL, Alfenas RCG, Debelo H, Wightman JD, Ferruzzi MG, Mattes RD. Effects of Concord grape juice flavor intensity and phenolic compound content on glycemia, appetite and cognitive function in adults with excess body weight: a randomized double-blind crossover trial. Food Funct. 2021 Nov 15;12(22):11469-11481. doi: 10.1039/d1fo02049h.

MeSH Terms

Conditions

Appetitive Behavior

Condition Hierarchy (Ancestors)

Behavior, AnimalBehavior

Study Officials

  • Richard D Mattes, PhD

    Purdue University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle Investigator

Study Record Dates

First Submitted

January 18, 2018

First Posted

January 24, 2018

Study Start

October 10, 2018

Primary Completion

March 28, 2019

Study Completion

September 20, 2019

Last Updated

November 5, 2020

Record last verified: 2019-08

Locations