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

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ClinicalTrials.gov Identifier: NCT03986775
Recruitment Status : Completed
First Posted : June 14, 2019
Last Update Posted : June 17, 2019
Sponsor:
Information provided by (Responsible Party):
Beneo-Institute

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

Condition or disease Intervention/treatment Phase
Overweight and Obesity Dietary Supplement: isomaltulose Dietary Supplement: sucrose Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
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
Actual Study Start Date : August 1, 2016
Actual Primary Completion Date : March 3, 2017
Actual Study Completion Date : August 9, 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Sucrose

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




Primary Outcome Measures :
  1. Brachial ultrasound FMD scan [ Time Frame: Baseline, 60 minutes, 120 minutes, 180 minutes ]
    Changes in postprandial flow-mediated Dilation (endothelial function)


Secondary Outcome Measures :
  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)



Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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)

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Responsible Party: Beneo-Institute
ClinicalTrials.gov Identifier: NCT03986775     History of Changes
Other Study ID Numbers: AFCRO-066
First Posted: June 14, 2019    Key Record Dates
Last Update Posted: June 17, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Beneo-Institute:
Glycemic Index
Overweight
Endothelial function
carbohydrate

Additional relevant MeSH terms:
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Hypertension
Overweight
Vascular Diseases
Cardiovascular Diseases
Body Weight
Signs and Symptoms