NCT03331757

Brief Summary

This study determined the glycemic index and glycemic load of six Greek honey varieties

Trial Health

87
On Track

Trial Health Score

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

Enrollment
11

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2017

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

February 12, 2017

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 12, 2017

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 2, 2017

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 31, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 6, 2017

Completed
Last Updated

November 6, 2017

Status Verified

November 1, 2017

Enrollment Period

2 months

First QC Date

October 31, 2017

Last Update Submit

November 1, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • Capillary blood glucose responses

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

    2 hours

Secondary Outcomes (1)

  • Subjective appetite rating

    2 hours

Study Arms (7)

Glucose as reference food

EXPERIMENTAL

Eleven metabolically healthy, normal weight subjects (male: 2, female: 9) after 10-14 hr fast, consumed 50g available carbohydrate from D-glucose, tested three times, in different weeks as reference food along with 300ml 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 drink.

Other: Glucose as reference foodOther: Fir honeyOther: Heather honeyOther: Citrus honeyOther: Pine honeyOther: Thyme honeyOther: Chestnut honey

Fir honey

EXPERIMENTAL

Eleven metabolically healthy, normal weight subjects (male: 2, female: 9) after 10-14 hr fast, consumed 50g available carbohydrate from fir honey, tested once, along with 300ml 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 drink.

Other: Glucose as reference foodOther: Fir honeyOther: Heather honeyOther: Citrus honeyOther: Pine honeyOther: Thyme honeyOther: Chestnut honey

Heather honey

EXPERIMENTAL

Eleven metabolically healthy, normal weight subjects (male: 2, female: 9) after 10-14 hr fast, consumed 50g available carbohydrate from heather honey, tested once, along with 300ml 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 drink.

Other: Glucose as reference foodOther: Fir honeyOther: Heather honeyOther: Citrus honeyOther: Pine honeyOther: Thyme honeyOther: Chestnut honey

Citrus honey

EXPERIMENTAL

Eleven metabolically healthy, normal weight subjects (male: 2, female: 9) after 10-14 hr fast, consumed 50g available carbohydrate from citrus honey, tested once, along with 300ml 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 drink.

Other: Glucose as reference foodOther: Fir honeyOther: Heather honeyOther: Citrus honeyOther: Pine honeyOther: Thyme honeyOther: Chestnut honey

Pine honey

EXPERIMENTAL

Eleven metabolically healthy, normal weight subjects (male: 2, female: 9) after 10-14 hr fast, consumed 50g available carbohydrate from pine honey, tested once, along with 300ml 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 drink.

Other: Glucose as reference foodOther: Fir honeyOther: Heather honeyOther: Citrus honeyOther: Pine honeyOther: Thyme honeyOther: Chestnut honey

Thyme honey

EXPERIMENTAL

Eleven metabolically healthy, normal weight subjects (male: 2, female: 9) after 10-14 hr fast, consumed 50g available carbohydrate from thyme honey, tested once, along with 300ml 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 drink.

Other: Glucose as reference foodOther: Fir honeyOther: Heather honeyOther: Citrus honeyOther: Pine honeyOther: Thyme honeyOther: Chestnut honey

Chestnut honey

EXPERIMENTAL

Eleven metabolically healthy, normal weight subjects (male: 2, female: 9) after 10-14 hr fast, consumed 50g available carbohydrate from chestnut honey, tested once, along with 300ml 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 drink.

Other: Glucose as reference foodOther: Fir honeyOther: Heather honeyOther: Citrus honeyOther: Pine honeyOther: Thyme honeyOther: Chestnut honey

Interventions

Eleven subjects (male: 2, female: 9) consumed 50g glucose diluted in 300ml water, tested three times, in different weeks, within 5-10min. Fingertip capillary blood glucose samples were taken at baseline, 15, 30, 45, 60, 90 and 120min.

Chestnut honeyCitrus honeyFir honeyGlucose as reference foodHeather honeyPine honeyThyme honey

Eleven subjects (male: 2, female: 9) consumed 50g available carbohydrates of fir honey diluted in 300ml water, tested once, within 5-10min. Fingertip capillary blood glucose samples were taken at baseline, 15, 30, 45, 60, 90 and 120min.

Chestnut honeyCitrus honeyFir honeyGlucose as reference foodHeather honeyPine honeyThyme honey

Eleven subjects (male: 2, female: 9) consumed 50g available carbohydrates of heather honey diluted in 300ml water, tested once, within 5-10min. Fingertip capillary blood glucose samples were taken at baseline, 15, 30, 45, 60, 90 and 120min.

Chestnut honeyCitrus honeyFir honeyGlucose as reference foodHeather honeyPine honeyThyme honey

Eleven subjects (male: 2, female: 9) consumed 50g available carbohydrates of citrus honey diluted in 300ml water, tested once, within 5-10min. Fingertip capillary blood glucose samples were taken at baseline, 15, 30, 45, 60, 90 and 120min.

Chestnut honeyCitrus honeyFir honeyGlucose as reference foodHeather honeyPine honeyThyme honey

Eleven subjects (male: 2, female: 9) consumed 50g available carbohydrates of pine honey diluted in 300ml water, tested once, within 5-10min. Fingertip capillary blood glucose samples were taken at baseline, 15, 30, 45, 60, 90 and 120min.

Chestnut honeyCitrus honeyFir honeyGlucose as reference foodHeather honeyPine honeyThyme honey

Eleven subjects (male: 2, female: 9) consumed 50g available carbohydrates of thyme honey diluted in 300ml water, tested once, within 5-10min. Fingertip capillary blood glucose samples were taken at baseline, 15, 30, 45, 60, 90 and 120min.

Chestnut honeyCitrus honeyFir honeyGlucose as reference foodHeather honeyPine honeyThyme honey

Eleven subjects (male: 2, female: 9) consumed 50g available carbohydrates of chestnut honey diluted in 300ml water, tested once, within 5-10min. Fingertip capillary blood glucose samples were taken at baseline, 15, 30, 45, 60, 90 and 120min.

Chestnut honeyCitrus honeyFir honeyGlucose as reference foodHeather honeyPine honeyThyme honey

Eligibility Criteria

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

You may qualify if:

  • healthy
  • non-smoking
  • individuals with normal body mass index (between 18.5 and 24.9 kg/m2)

You may not qualify if:

  • coronary heart disease
  • diabetes mellitus
  • kidney disease
  • 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, 11855, Greece

Location

MeSH Terms

Conditions

Appetitive Behavior

Interventions

Glucose

Condition Hierarchy (Ancestors)

Behavior, AnimalBehavior

Intervention Hierarchy (Ancestors)

HexosesMonosaccharidesSugarsCarbohydrates

Study Officials

  • Emilia Papakonstantinou, PhD

    Agricultural University of Athens

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
Participants were assigned to the interventions using a sequence of random numbers extracted from computer software. A researcher not involved with the collection and the analysis of the scientific data, was responsible for the randomization of the volunteers to the intervention days examining the test foods. All test meals (glucose and honeys) were diluted in 300ml water and were served in dark paper cups covered with a lid in order to achieve double blind conditions.
Purpose
OTHER
Intervention Model
CROSSOVER
Model Details: Eleven healthy participants consumed in random order 50g available carbohydrates as glucose (tested three times) and 50g available carbohydrates as fir, chestnut, healther, thyme, pine, citrus, tested once, on separate occasions
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Primary investigator

Study Record Dates

First Submitted

October 31, 2017

First Posted

November 6, 2017

Study Start

February 12, 2017

Primary Completion

April 12, 2017

Study Completion

September 2, 2017

Last Updated

November 6, 2017

Record last verified: 2017-11

Data Sharing

IPD Sharing
Will not share

Locations