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

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

Study Overview

• Status: Completed
• Conditions: Overweight and Obesity
• Intervention / Treatment: Dietary supplement: isomaltulose; Dietary supplement: sucrose

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 46 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: citrus drink with isomaltulose	Dietary supplement: isomaltulose; replacement of sucrose with low-glycemic isomaltulose
Placebo Comparator: citrus drink with sucrose	Dietary supplement: sucrose; conventional beverage with sucrose

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Beneo-Institute

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2016
• Primary Completion (Actual): March 3, 2017
• Study Completion (Actual): August 9, 2017

Study Registration Dates

• First Submitted: June 11, 2019
• First Submitted That Met QC Criteria: June 13, 2019
• First Posted (Actual): June 14, 2019

Study Record Updates

• Last Update Posted (Actual): June 17, 2019
• Last Update Submitted That Met QC Criteria: June 14, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Keywords: Overweight; Endothelial function; Glycemic Index; carbohydrate
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Body Weight; Hypertension; Overweight
• Other Study ID Numbers: AFCRO-066

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No