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

NCT ID: NCT03986775

Last Updated: 2019-06-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-08-01

Study Completion Date

2017-08-09

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.

Detailed Description

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Conditions

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Overweight and Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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citrus drink with isomaltulose

Group Type ACTIVE_COMPARATOR

isomaltulose

Intervention Type DIETARY_SUPPLEMENT

replacement of sucrose with low-glycemic isomaltulose

citrus drink with sucrose

Group Type PLACEBO_COMPARATOR

sucrose

Intervention Type DIETARY_SUPPLEMENT

conventional beverage with sucrose

Interventions

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isomaltulose

replacement of sucrose with low-glycemic isomaltulose

Intervention Type DIETARY_SUPPLEMENT

sucrose

conventional beverage with sucrose

Intervention Type DIETARY_SUPPLEMENT

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)
Minimum Eligible Age

25 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Beneo-Institute

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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AFCRO-066

Identifier Type: -

Identifier Source: org_study_id

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