Efficacy of Palatinose™ Versus Sucrose on Flow Mediated Dilation in Healthy Subjects With Mild Hypertension
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
1 other identifier
interventional
80
0 countries
N/A
Brief Summary
To determine the efficacy of Palatinose versus sucrose on Flow Mediated Dilation (FMD) in healthy subjects with mild hypertension.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Aug 2016
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 3, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
August 9, 2017
CompletedFirst Submitted
Initial submission to the registry
June 11, 2019
CompletedFirst Posted
Study publicly available on registry
June 14, 2019
CompletedJune 17, 2019
June 1, 2019
7 months
June 11, 2019
June 14, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Brachial ultrasound FMD scan
Changes in postprandial flow-mediated Dilation (endothelial function)
Baseline, 60 minutes, 120 minutes, 180 minutes
Secondary Outcomes (2)
Postprandial glycemic response
Baseline, 60 minutes, 120 minutes, 180 minutes
Postprandial insulin response
Baseline, 60 minutes, 120 minutes, 180 minutes
Study Arms (2)
citrus drink with isomaltulose
ACTIVE COMPARATORcitrus drink with sucrose
PLACEBO COMPARATORInterventions
replacement of sucrose with low-glycemic isomaltulose
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Beneo-Institutelead
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 11, 2019
First Posted
June 14, 2019
Study Start
August 1, 2016
Primary Completion
March 3, 2017
Study Completion
August 9, 2017
Last Updated
June 17, 2019
Record last verified: 2019-06
Data Sharing
- IPD Sharing
- Will not share