Orange Juice and Glycaemic Control in Type 2 Diabetes Mellitus

Hasselt University

Status: Completed

Conditions: Diabetes Mellitus, Type 2

Treatments: Other: Sugar-sweetened orange-flavoured beverage; Other: Whole orange juice with skin removed; Other: orange juice concentrate

Study type: Interventional

Funder types: Other

Identifiers

NCT04412798

Orange -Juice-001

Details and patient eligibility

About

The evidence on the consumption of 100% orange juice in people with type 2 diabetes is highly variable and largely out-of-date, with a few studies reporting acute negative glycaemic effects when 100% orange juice is drunk with or without a meal.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

Enrollment: 15 patients

Sex: All

Ages: 25 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Inclusion Criteria: individuals (aged 25-75 years) with up to 8 years of T2DM, according to ADA criteria (Two-hour plasma glucose ≥200 mg/dL (11.1 mmol/L) during OGTT. The test should be performed as described by the WHO, using a glucose load containing the equivalent of 75-g anhydrous glucose dissolved in water; or HbA1c > ≥6.5% (48 mmol/mol)).

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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15 participants in 3 patient groups

group 1

Other group

Description:

orange juice concentrate

Treatment:

Other: orange juice concentrate

Group 2

Other group

Description:

Sugar-sweetened orange-flavoured beverage

Treatment:

Other: Sugar-sweetened orange-flavoured beverage

Group 3

Other group

Description:

Whole orange juice with skin removed

Treatment:

Other: Whole orange juice with skin removed