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

Primary Purpose

Overweight and Obesity

Status

Completed

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

isomaltulose

sucrose

About this trial

This is an interventional basic science trial for Overweight and Obesity focused on measuring Glycemic Index, Overweight, Endothelial function, carbohydrate

Eligibility Criteria

25 Years - 50 Years (Adult)All SexesAccepts 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)

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

citrus drink with isomaltulose

citrus drink with sucrose

Arm Description

Outcomes

Primary Outcome Measures

Brachial ultrasound FMD scan

Changes in postprandial flow-mediated Dilation (endothelial function)

Secondary Outcome Measures

Postprandial glycemic response

Postprandial glycemic response (Plasma samples)

Postprandial insulin response

Postprandial Insulin response (Plasma samples)

Full Information

NCT ID

NCT03986775

First Posted

June 11, 2019

Last Updated

June 14, 2019

Sponsor

Beneo-Institute

1. Study Identification

Unique Protocol Identification Number

NCT03986775

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2019

Overall Recruitment Status

Completed

Study Start Date

August 1, 2016 (Actual)

Primary Completion Date

March 3, 2017 (Actual)

Study Completion Date

August 9, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Beneo-Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Overweight and Obesity

Keywords

Glycemic Index, Overweight, Endothelial function, carbohydrate

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

80 (Actual)

8. Arms, Groups, and Interventions

Arm Title

citrus drink with isomaltulose

Arm Type

Active Comparator

Arm Title

citrus drink with sucrose

Arm Type

Placebo Comparator

Intervention Type

Dietary Supplement

Intervention Name(s)

isomaltulose

Intervention Description

replacement of sucrose with low-glycemic isomaltulose

Intervention Type

Dietary Supplement

Intervention Name(s)

sucrose

Intervention Description

conventional beverage with sucrose

Primary Outcome Measure Information:

Title

Brachial ultrasound FMD scan

Description

Changes in postprandial flow-mediated Dilation (endothelial function)

Time Frame

Baseline, 60 minutes, 120 minutes, 180 minutes

Secondary Outcome Measure Information:

Title

Postprandial glycemic response

Description

Postprandial glycemic response (Plasma samples)

Time Frame

Baseline, 60 minutes, 120 minutes, 180 minutes

Title

Postprandial insulin response

Description

Postprandial Insulin response (Plasma samples)

Time Frame

Baseline, 60 minutes, 120 minutes, 180 minutes

10. Eligibility

Sex

All

Minimum Age & Unit of Time

25 Years

Maximum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility Criteria

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)

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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