NCT04857554

Brief Summary

This study investigated the effects of three commonly used sugar-free snacks with added sweeteners on glycemic responses

Trial Health

87
On Track

Trial Health Score

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

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2020

Shorter than P25 for not_applicable

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

Study Start

First participant enrolled

July 30, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2020

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

April 21, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 23, 2021

Completed
Last Updated

April 23, 2021

Status Verified

April 1, 2021

Enrollment Period

2 months

First QC Date

April 21, 2021

Last Update Submit

April 21, 2021

Conditions

Potential Abnormality of Glucose ToleranceAppetitive Behavior

Keywords

blood glucoseglycemic indexcereal barjamcocoa

Outcome Measures

Primary Outcomes (1)

  • Capillary blood glucose responses

    Clinically useful change in blood glucose, defined as the restoration of glucose within normal limits during the 2hr glucose tolerance test

    2 hours

Secondary Outcomes (1)

  • Subjective appetite ratings

    2 hours

Study Arms (5)

Glucose as reference food

EXPERIMENTAL

Twelve healthy, normal weight subjects (male: 6, female: 6) after 10-14 hr fast, consumed 25g available carbohydrate from D-glucose, three times, in different weeks as reference food along with 250ml water; and 25g available carbohydrates from white bread, white bread and apricot jam, cereal bar with cranberries, and cocoa drink, tested once, in different weeks along with 250ml water or 500ml fat-free milk for the cocoa drink. Fingertip capillary blood glucose samples were taken at baseline, 15, 30, 45, 60, 90 and 120min. The first glucose sample was taken exactly 15min after the first bite of food or drink.

Other: Glucose as reference foodOther: White bread as reference foodOther: White bread with apricot jamOther: Cereal bar with cranberriesOther: Cocoa drink

White bread as reference food

EXPERIMENTAL

Twelve healthy, normal weight subjects (male: 6, female: 6) after 10-14 hr fast, consumed 25g available carbohydrate from D-glucose, three times, in different weeks as reference food along with 250ml water; and 25g available carbohydrates from white bread, white bread and apricot jam, cereal bar with cranberries, and cocoa drink, tested once, in different weeks along with 250ml water or 500ml fat-free milk for the cocoa drink. Fingertip capillary blood glucose samples were taken at baseline, 15, 30, 45, 60, 90 and 120min. The first glucose sample was taken exactly 15min after the first bite of food or drink.

Other: Glucose as reference foodOther: White bread as reference foodOther: White bread with apricot jamOther: Cereal bar with cranberriesOther: Cocoa drink

White bread with apricot jam

EXPERIMENTAL

Twelve healthy, normal weight subjects (male: 6, female: 6) after 10-14 hr fast, consumed 25g available carbohydrate from D-glucose, three times, in different weeks as reference food along with 250ml water; and 25g available carbohydrates from white bread, white bread and apricot jam, cereal bar with cranberries, and cocoa drink, tested once, in different weeks along with 250ml water or 500ml fat-free milk for the cocoa drink. Fingertip capillary blood glucose samples were taken at baseline, 15, 30, 45, 60, 90 and 120min. The first glucose sample was taken exactly 15min after the first bite of food or drink.

Other: Glucose as reference foodOther: White bread as reference foodOther: White bread with apricot jamOther: Cereal bar with cranberriesOther: Cocoa drink

Cereal bar with cranberries

EXPERIMENTAL

Twelve healthy, normal weight subjects (male: 6, female: 6) after 10-14 hr fast, consumed 25g available carbohydrate from D-glucose, three times, in different weeks as reference food along with 250ml water; and 25g available carbohydrates from white bread, white bread and apricot jam, cereal bar with cranberries, and cocoa drink, tested once, in different weeks along with 250ml water or 500ml fat-free milk for the cocoa drink. Fingertip capillary blood glucose samples were taken at baseline, 15, 30, 45, 60, 90 and 120min. The first glucose sample was taken exactly 15min after the first bite of food or drink.

Other: Glucose as reference foodOther: White bread as reference foodOther: White bread with apricot jamOther: Cereal bar with cranberriesOther: Cocoa drink

Cocoa drink

EXPERIMENTAL

Twelve healthy, normal weight subjects (male: 6, female: 6) after 10-14 hr fast, consumed 25g available carbohydrate from D-glucose, three times, in different weeks as reference food along with 250ml water; and 25g available carbohydrates from white bread, white bread and apricot jam, cereal bar with cranberries, and cocoa drink, tested once, in different weeks along with 250ml water or 500ml fat-free milk for the cocoa drink. Fingertip capillary blood glucose samples were taken at baseline, 15, 30, 45, 60, 90 and 120min. The first glucose sample was taken exactly 15min after the first bite of food or drink.

Other: Glucose as reference foodOther: White bread as reference foodOther: White bread with apricot jamOther: Cereal bar with cranberriesOther: Cocoa drink

Interventions

Glucose as reference foodOTHER

Twelve healthy, normal weight subjects (male: 6,female: 6) after 10-14 hr fast, consumed 25g glucose diluted in 250ml water, tested twice, in different weeks, within 5-10min. Fingertip capillary blood glucose samples were taken at baseline, 15, 30, 45,60, 90 and 120min.

Cereal bar with cranberriesCocoa drinkGlucose as reference foodWhite bread as reference foodWhite bread with apricot jam
White bread as reference foodOTHER

Twelve healthy, normal weight subjects (male: 6,female: 6) after 10-14 hr fast, consumed 25g available carbohydrates from white bread along with 250ml water, tested once, in different weeks, within 10-15min. Fingertip capillary blood glucose samples were taken at baseline, 15, 30, 45,60, 90 and 120min.

Cereal bar with cranberriesCocoa drinkGlucose as reference foodWhite bread as reference foodWhite bread with apricot jam
White bread with apricot jamOTHER

Twelve healthy, normal weight subjects (male: 6,female: 6) after 10-14 hr fast, consumed 25g available carbohydrates from white bread together with apricot jam along with 250ml water, tested once, in different weeks, within 10-15min. Fingertip capillary blood glucose samples were taken at baseline, 15, 30, 45,60, 90 and 120min.

Cereal bar with cranberriesCocoa drinkGlucose as reference foodWhite bread as reference foodWhite bread with apricot jam
Cereal bar with cranberriesOTHER

Twelve healthy, normal weight subjects (male: 6,female: 6) after 10-14 hr fast, consumed 25g available carbohydrates from a cereal bar with cranberries along with 250ml water, tested once, in different weeks, within 10-15min. Fingertip capillary blood glucose samples were taken at baseline, 15, 30, 45,60, 90 and 120min.

Cereal bar with cranberriesCocoa drinkGlucose as reference foodWhite bread as reference foodWhite bread with apricot jam
Cocoa drinkOTHER

Twelve healthy, normal weight subjects (male: 6,female: 6) after 10-14 hr fast, consumed 25g available carbohydrates from cocoa powder mixed with 500ml fat-free milk, tested once, in different weeks, within 5-10min. Fingertip capillary blood glucose samples were taken at baseline, 15, 30, 45,60, 90 and 120min.

Cereal bar with cranberriesCocoa drinkGlucose as reference foodWhite bread as reference foodWhite bread with apricot jam

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • healthy
  • non-smoking
  • non-diabetic men and women
  • body mass index (BMI) between 18 and 29.9 kg/m2

You may not qualify if:

  • severe chronic disease (e.g. coronary heart disease, diabetes mellitus,kidney or liver conditions, endocrine conditions)
  • gastrointestinal disorders
  • pregnancy
  • lactation
  • competitive sports
  • alcohol
  • drug dependency

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Agricultural University of Athens

Athens, Attica, 11855, Greece

Location

MeSH Terms

Conditions

Appetitive Behavior

Interventions

Glucose

Condition Hierarchy (Ancestors)

Behavior, AnimalBehavior

Intervention Hierarchy (Ancestors)

HexosesMonosaccharidesSugarsCarbohydrates

Study Officials

  • Aimilia Papakonstantinou, PhD

    Agricultural University of Athens

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Masking Details
Single (Investigator)
Purpose
OTHER
Intervention Model
CROSSOVER
Model Details: Crossover Assignment
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

April 21, 2021

First Posted

April 23, 2021

Study Start

July 30, 2020

Primary Completion

September 30, 2020

Study Completion

September 30, 2020

Last Updated

April 23, 2021

Record last verified: 2021-04

Locations

GR(1)