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

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

Official Title
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AFCRO-066: A Double-blinded, Randomized, Controlled, Acute, Cross-over Study to Determine the Efficacy of Palatinose™ Versus Sucrose on Flow Mediated Dilation in Healthy Subjects With Mild Hypertension

Conditions
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Overweight and Obesity

Intervention / Treatment
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* Dietary Supplement: isomaltulose
* Dietary Supplement: sucrose


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: citrus drink with isomaltulose<br> | Dietary Supplement: isomaltulose<br>* replacement of sucrose with low-glycemic isomaltulose<br>|
| Placebo Comparator: citrus drink with sucrose<br> | Dietary Supplement: sucrose<br>* conventional beverage with sucrose<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Brachial ultrasound FMD scan | Changes in postprandial flow-mediated Dilation (endothelial function) | Baseline, 60 minutes, 120 minutes, 180 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postprandial glycemic response | Postprandial glycemic response (Plasma samples) | Baseline, 60 minutes, 120 minutes, 180 minutes | 
| Postprandial insulin response | Postprandial Insulin response (Plasma samples) | Baseline, 60 minutes, 120 minutes, 180 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Glycemic Index, Overweight, Endothelial function, carbohydrate