Orange Juice and Glycaemic Control in Type 2 Diabetes Mellitus

NCT ID: NCT04412798

Last Updated: 2024-05-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-05-01

Study Completion Date

2024-04-01

Brief Summary

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The evidence on the consumption of 100% orange juice in people with type 2 diabetes is highly variable and largely out-of-date, with a few studies reporting acute negative glycaemic effects when 100% orange juice is drunk with or without a meal. The aim of the project is to study the impact of the intake of a single serving of 100% orange juice on glycaemic control in male patients with pre-existing type 2 diabetes mellitus. In addition, immunological parameters and Alzheimer disease related biomarkers will be assessed to examine the chronic inflammatory state of these patients

Detailed Description

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Conditions

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Diabetes Mellitus, Type 2

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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group 1

orange juice concentrate

Group Type OTHER

orange juice concentrate

Intervention Type OTHER

250mL of 100% orange juice made from concentrate

Group 2

Sugar-sweetened orange-flavoured beverage

Group Type OTHER

Sugar-sweetened orange-flavoured beverage

Intervention Type OTHER

Sugar-sweetened orange-flavoured beverage, energy-matched to the orange juice condition

Group 3

Whole orange juice with skin removed

Group Type OTHER

Whole orange juice with skin removed

Intervention Type OTHER

Whole orange pieces with skin removed, energy-matched to the orange juice condition

Interventions

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orange juice concentrate

250mL of 100% orange juice made from concentrate

Intervention Type OTHER

Sugar-sweetened orange-flavoured beverage

Sugar-sweetened orange-flavoured beverage, energy-matched to the orange juice condition

Intervention Type OTHER

Whole orange juice with skin removed

Whole orange pieces with skin removed, energy-matched to the orange juice condition

Intervention Type OTHER

Eligibility Criteria

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Exclusion Criteria

* pregnancy,
* participants on exogenous insulin therapy,
* HbA1c \>8.5%,
* BMI \<22 or \>35 kg/m²,
* regular smokers (\>1 cigarette per day),
* participants with established cardiovascular disease,
* neurological disease,
* cancer,
* renal disease.
* Participants who are unwilling to consume any of the standard foods/drinks
Minimum Eligible Age

25 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hochschule Geisenheim University

UNKNOWN

Sponsor Role collaborator

Hasselt University

OTHER

Sponsor Role lead

Responsible Party

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Dominique Hansen

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Dominique Hansen, prof. dr.

Role: PRINCIPAL_INVESTIGATOR

Hasselt University

Locations

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Hasselt University

Hasselt, , Belgium

Site Status

Countries

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Belgium

Other Identifiers

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Orange -Juice-001

Identifier Type: -

Identifier Source: org_study_id

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