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OpenTrials
Completed

NCT Number: NCT03986775

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.

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Key information

Conditions

Overweight and Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

25 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

isomaltulose

Dietary Supplement

replacement of sucrose with low-glycemic isomaltulose

Sucrose

Dietary Supplement

conventional beverage with sucrose

Primary outcomes

  1. Brachial ultrasound FMD scan

    Time frame: Baseline, 60 minutes, 120 minutes, 180 minutes

    Changes in postprandial flow-mediated Dilation (endothelial function)

Secondary outcomes

  1. Postprandial glycemic response

    Time frame: Baseline, 60 minutes, 120 minutes, 180 minutes

    Postprandial glycemic response (Plasma samples)

  2. Postprandial insulin response

    Time frame: Baseline, 60 minutes, 120 minutes, 180 minutes

    Postprandial Insulin response (Plasma samples)

Sponsors and collaborators

Lead sponsor

Beneo-Institute

Industry

Registry information

Official study 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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Jun 14, 2019
Registry last updated
Jun 17, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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