NCT06163937

Brief Summary

This study investigated the acute effects of two fruit juices on postprandial glycemic responses and satiety in healthy individuals

Trial Health

87
On Track

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2023

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 15, 2023

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2023

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

December 1, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

December 11, 2023

Completed
Last Updated

June 14, 2024

Status Verified

June 1, 2024

Enrollment Period

1 month

First QC Date

December 1, 2023

Last Update Submit

June 13, 2024

Conditions

Keywords

blood glucosefruit juiceglycemic indexglycemic loadsatiety

Outcome Measures

Primary Outcomes (2)

  • Glycemic index

    Glucose solution (50 g) was the reference food (GI = 100%) against which all test foods were compared. Subjects arrived at the laboratory at eight to nine o'clock in the morning after 10-12 h overnight fast. Each subject was fed equivalent 50 g available carbohydrate of test foods or reference food in random order. To minimize day to day variation of glucose tolerance, the reference food was tested in triplicate in each subject. All test and reference foods were served with 250 mL of water. An automatic lancet device and glucometer (calibrated MediSmart Ruby glucose meter with a lancing device, Lilly-PHARMASERV SA, Greece) was used for finger capillary blood samples. Blood samples were taken immediately before the start of the study (0 min) and 15, 30, 45, 60, 90 and 120 min after the start of eating.

    2 hours

  • 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 (3)

Glucose as reference food

EXPERIMENTAL

Ten healthy, normal-weight adults after 10-14 hours of fasting, consumed 50g available carbohydrates from D-glucose, tested three times, in different visits as reference food; and 50g available carbohydrates from orange juice and mixed fruit juice (consisted of apple, orange, grape, and pomegranate), each tested once, in different visits, along with 300mL water. There was a washout period of at least two days between visits. Fingertip capillary blood glucose samples were taken at baseline, 15, 30, 45, 60, 90 and 120min after beverage consumption. The first glucose sample was taken exactly 15min after the first sip of drink.

Other: Glucose as reference food

Orange juice

EXPERIMENTAL

Ten healthy, normal-weight adults after 10-14 hours of fasting, consumed 50g available carbohydrates from D-glucose, tested three times, in different visits as reference food; and 50g available carbohydrates from orange juice and mixed fruit juice (consisted of apple, orange, grape, and pomegranate), each tested once, in different visits, along with 300mL water. There was a washout period of at least two days between visits. Fingertip capillary blood glucose samples were taken at baseline, 15, 30, 45, 60, 90 and 120min after beverage consumption. The first glucose sample was taken exactly 15min after the first sip of drink.

Other: Orange juice

Mixed fruit juice

EXPERIMENTAL

Ten healthy, normal-weight adults after 10-14 hours of fasting, consumed 50g available carbohydrates from D-glucose, tested three times, in different visits as reference food; and 50g available carbohydrates from orange juice and mixed fruit juice (consisted of apple, orange, grape, and pomegranate), each tested once, in different visits, along with 300mL water. There was a washout period of at least two days between visits. Fingertip capillary blood glucose samples were taken at baseline, 15, 30, 45, 60, 90 and 120min after beverage consumption. The first glucose sample was taken exactly 15min after the first sip of drink.

Other: Mixed fruit juice

Interventions

Ten healthy, normal-weight subjects after 10-14 hours of fasting, consumed 50g glucose diluted in 300ml water, tested three times, in different visits, within 5-10min. Fingertip capillary blood glucose samples were taken at baseline, 15, 30, 45, 60, 90 and 120 min.

Glucose as reference food

Ten healthy, normal-weight subjects after 10-14 hours of fasting, consumed 50g available carbohydrates from orange juice, tested once, within 5-10min. Fingertip capillary blood glucose samples were taken at baseline, 15, 30, 45, 60, 90 and 120 min.

Orange juice

Ten healthy, normal-weight subjects after 10-14 hours of fasting, consumed 50g available carbohydrates from mixed fruit juice (consisted of apple, orange, grape, and pomegranate), tested once, within 5-10min. Fingertip capillary blood glucose samples were taken at baseline, 15, 30, 45, 60, 90 and 120 min.

Mixed fruit juice

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • healthy
  • non-smoking
  • non-diabetic and normotensive men and women
  • body mass index between 18.5 and 25 kg/m2

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Agricultural University of Athens

Athens, Attica, 11855, Greece

Location

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
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Triple-blind
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

December 1, 2023

First Posted

December 11, 2023

Study Start

September 1, 2023

Primary Completion

October 15, 2023

Study Completion

October 30, 2023

Last Updated

June 14, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will not share

Locations