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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03986775

Enrollment

Registered

2019-06-14

Start date

2016-08-01

Completion date

2017-08-09

Last updated

2019-06-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Overweight and Obesity

Keywords

Glycemic Index, Overweight, Endothelial function, carbohydrate

Brief summary

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

Interventions

DIETARY_SUPPLEMENTisomaltulose

replacement of sucrose with low-glycemic isomaltulose

DIETARY_SUPPLEMENTsucrose

conventional beverage with sucrose

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

BASIC_SCIENCE

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

25 Years to 50 Years

Healthy volunteers

Yes

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)

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
Postprandial glycemic response	Baseline, 60 minutes, 120 minutes, 180 minutes	Postprandial glycemic response (Plasma samples)
Postprandial insulin response	Baseline, 60 minutes, 120 minutes, 180 minutes	Postprandial Insulin response (Plasma samples)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026