NCT04831268

Brief Summary

This study investigated the effects of Greek traditional meals in dehydrated form consumed after reconstitution with water 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 Sep 2019

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

September 1, 2019

Completed
29 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2019

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

April 1, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 5, 2021

Completed
Last Updated

April 8, 2021

Status Verified

April 1, 2021

Enrollment Period

29 days

First QC Date

April 1, 2021

Last Update Submit

April 4, 2021

Conditions

Potential Abnormality of Glucose ToleranceAppetitive Behavior

Keywords

blood glucoselentilstrahanashalvaglycemic index

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 (2)

  • Subjective appetite ratings

    2 hours

  • Blood pressure

    2 hours

Study Arms (4)

Glucose as reference food

EXPERIMENTAL

Twelve healthy, normal weight subjects (male: 7, female: 7\) 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 lentils and lupins, trahanas with tomato sauce and halva with currants, tested once, in different weeks along with 250ml water. 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: Lentils and lupins mixed mealOther: Trahanas with tomato sauce mixed mealOther: Halva with currants mixed meal

Lentils and lupins mixed meal

EXPERIMENTAL

Twelve healthy, normal weight subjects (male: 7, female: 7\) 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 lentils and lupins, trahanas with tomato sauce and halva with currants, tested once, in different weeks along with 250ml water. 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: Lentils and lupins mixed mealOther: Trahanas with tomato sauce mixed mealOther: Halva with currants mixed meal

Trahanas with tomato sauce mixed meal

EXPERIMENTAL

Twelve healthy, normal weight subjects (male: 7, female: 7\) 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 lentils and lupins, trahanas with tomato sauce and halva with currants, tested once, in different weeks along with 250ml water. 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: Lentils and lupins mixed mealOther: Trahanas with tomato sauce mixed mealOther: Halva with currants mixed meal

Halva with currants mixed meal

EXPERIMENTAL

Twelve healthy, normal weight subjects (male: 7, female: 7\) 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 lentils and lupins, trahanas with tomato sauce and halva with currants, tested once, in different weeks along with 250ml water. 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: Lentils and lupins mixed mealOther: Trahanas with tomato sauce mixed mealOther: Halva with currants mixed meal

Interventions

Glucose as reference foodOTHER

Twelve healthy, normal weight subjects (male: 7, female:7) after 10-14 hr fast, consumed 25g glucose diluted in 250ml water, tested three times, in different weeks, within 5-10min. Fingertip capillary blood glucose samples were takenat baseline, 15, 30, 45, 60, 90 and 120min.

Glucose as reference foodHalva with currants mixed mealLentils and lupins mixed mealTrahanas with tomato sauce mixed meal
Lentils and lupins mixed mealOTHER

Twelve healthy, normal weight subjects (male: 7, female:7) after 10-14 hr fast, consumed 25g available carbohydrates from lentils and lupins mixed meal along with 250ml water, tested once, in different weeks, within 10-15min. Fingertip capillary blood glucose samples were takenat baseline, 15, 30, 45, 60, 90 and 120min.

Glucose as reference foodHalva with currants mixed mealLentils and lupins mixed mealTrahanas with tomato sauce mixed meal
Trahanas with tomato sauce mixed mealOTHER

Twelve healthy, normal weight subjects (male: 7, female:7) after 10-14 hr fast, consumed 25g available carbohydrates from trahanas with tomato sauce mixed meal along with 250ml water, tested once, in different weeks, within 10-15min. Fingertip capillary blood glucose samples were takenat baseline, 15, 30, 45, 60, 90 and 120min.

Glucose as reference foodHalva with currants mixed mealLentils and lupins mixed mealTrahanas with tomato sauce mixed meal
Halva with currants mixed mealOTHER

Twelve healthy, normal weight subjects (male: 7, female:7) after 10-14 hr fast, consumed 25g available carbohydrates from halva with currants mixed meal along with 250ml water, tested once, in different weeks, within 10-15min. Fingertip capillary blood glucose samples were takenat baseline, 15, 30, 45, 60, 90 and 120min.

Glucose as reference foodHalva with currants mixed mealLentils and lupins mixed mealTrahanas with tomato sauce mixed meal

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • healthy
  • non-smoking
  • non-diabetic men and women
  • normal body mass index (BMI; between 18.5 and 25 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 1, 2021

First Posted

April 5, 2021

Study Start

September 1, 2019

Primary Completion

September 30, 2019

Study Completion

September 30, 2019

Last Updated

April 8, 2021

Record last verified: 2021-04

Locations

GR(1)