Efficacy of Palatinose™ Versus Sucrose on Flow Mediated D... | NCT03986775

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

NCT03986775

Sponsor

Beneo-Institute

Status

Completed

Last Update Posted

Jun 17, 2019Actual

Enrollment

80Actual

Phase

Not Applicable

Conditions

Overweight and Obesity

Interventions

isomaltulose
sucrose

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 1, 2016Actual

Primary Completion Date

Mar 3, 2017Actual

Completion Date

Aug 9, 2017Actual

First Submitted Date

Jun 11, 2019

First Submission Date that Met QC Criteria

Jun 13, 2019

First Posted Date

Jun 14, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 14, 2019

Last Update Posted Date

Jun 17, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

80Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
citrus drink with isomaltulose	Active Comparator		Dietary Supplement: isomaltulose
citrus drink with sucrose	Placebo Comparator		Dietary Supplement: sucrose

Interventions

Name	Type	Description	Arm Group Labels	Other Names
isomaltulose	Dietary Supplement	replacement of sucrose with low-glycemic isomaltulose	citrus drink with isomaltulose

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Brachial ultrasound FMD scan	Changes in postprandial flow-mediated Dilation (endothelial function)	Baseline, 60 minutes, 120 minutes, 180 minutes

Secondary Outcomes

Measure	Description	Time Frame
Postprandial glycemic response	Postprandial glycemic response (Plasma samples)	Baseline, 60 minutes, 120 minutes, 180 minutes
Postprandial insulin response	Postprandial Insulin response (Plasma samples)

Other Outcomes

Not provided

Eligibility Module

Eligibility 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)

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

25 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D050177	Overweight
D009765	Obesity

Ancestor Terms

ID	Term
D044343	Overnutrition
D009748	Nutrition Disorders
D009750	Nutritional and Metabolic Diseases
D001835	Body Weight

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C008189	isomaltulose
D013395	Sucrose

Ancestor Terms

ID	Term
D004187	Disaccharides
D009844	Oligosaccharides
D011134	Polysaccharides
D002241	Carbohydrates

Browse Leaves

Not provided

Browse Branches

Not provided