Efficacy of Palatinose™ Versus Sucrose on Flow Mediated Dilation in Healthy Subjects With Mild Hypertension

Beneo

Status: Completed

Conditions: Overweight and Obesity

Treatments: Dietary Supplement: sucrose; Dietary Supplement: isomaltulose

Study type: Interventional

Funder types: Industry

Identifiers

NCT03986775

AFCRO-066

Details and patient eligibility

About

To determine the efficacy of Palatinose versus sucrose on Flow Mediated Dilation (FMD) in healthy subjects with mild hypertension.

Enrollment: 80 patients

Sex: All

Ages: 25 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Subject is healthy at the time of pre-examination
• Subject has a BMI of 25 - 35 kg/m²
• Subject is aged 25 - 50 years at the time of pre-examination
• Signed written informed consent
• Inactive (IPAQ score <1)
• Waist to Hip ratio ≥0.90 cm for males, ≥0.85 cm for females
• High-normo/Mild hypertensive (SBP: 130-159 mmHg / DBP: 80-99 mmHg)

Exclusion criteria

• Use of medication interfering with RAAS, such as ACE-inhibitors,
• Advanced cardio-vascular disease (CVD),
• Severe kidney disorders (CKD),
• Diabetes mellitus, both type 1 and II diabetes,
• Pregnant, lactating or wish to become pregnant,
• Hypersensitivity to any of the components of the test product,
• Restricted diet (vegetarian)
• Thyroid disease
• Heavy Smokers (light smokers allowed)
• Lack of suitability for participation in the trial, for any medical reason, as judged by the PI.
• Excessive alcohol consumption (>21 units/week for males & >14 units/week for females)

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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80 participants in 2 patient groups, including a placebo group

citrus drink with isomaltulose

Active Comparator group

Treatment:

Dietary Supplement: isomaltulose

citrus drink with sucrose

Placebo Comparator group

Treatment:

Dietary Supplement: sucrose