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

Overweight and Obesity Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03986775
• Other study ID #: AFCRO-066
• Status: Completed
• Phase: N/A
• Start date: August 1, 2016
• Est. completion date: August 9, 2017

Study information

• Verified date: June 2019
• Source: Beneo-Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: August 9, 2017
• Est. primary completion date: March 3, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 25 Years to 50 Years

Eligibility

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)

Related Conditions & MeSH terms

• Hypertension
• Overweight
• Overweight and Obesity

Intervention

Dietary Supplement:
• isomaltulose
replacement of sucrose with low-glycemic isomaltulose
• sucrose
conventional beverage with sucrose

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Beneo-Institute

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Brachial ultrasound FMD scan	Changes in postprandial flow-mediated Dilation (endothelial function)	Baseline, 60 minutes, 120 minutes, 180 minutes
Secondary	Postprandial glycemic response	Postprandial glycemic response (Plasma samples)	Baseline, 60 minutes, 120 minutes, 180 minutes
Secondary	Postprandial insulin response	Postprandial Insulin response (Plasma samples)	Baseline, 60 minutes, 120 minutes, 180 minutes