Effects of Berry Nectars Sweetened With Inverted Sugar on... | NCT02743130

Studies
Effects of Berry Nectars Sweetened With Inverted Sugar on Post-meal Blood Sugar

NCT02743130

Sponsor

University of Eastern Finland

Status

Completed

Last Update Posted

Apr 19, 2016Estimated

Enrollment

18Actual

Phase

Not Applicable

Conditions

Hyperglycemia, Postprandial

Interventions

Blackcurrant Nectar
Lingonberry Nectar
Reference

Countries

Finland

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

Apr 2016

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

Sep 2014

Primary Completion Date

Nov 2014Actual

Completion Date

Nov 2014Actual

First Submitted Date

Apr 14, 2016

First Submission Date that Met QC Criteria

Apr 14, 2016

First Posted Date

Apr 19, 2016Estimated

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

Apr 14, 2016

Last Update Posted Date

Apr 19, 2016Estimated

Name	Class
Finnsugar Ltd	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Berries have been shown to improve postprandial glucose and insulin responses to sucrose. During processing and storage of berry products, sucrose is inverted to glucose and fructose. The effects of berries on the glycemic response induced by inverted sugar are not known. The purpose of this study is to determine whether berries are effective in lowering the postprandial glucose and insulin responses induced by inverted sugar.

Detailed Description

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

18Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Blackcurrant nectar	Experimental	Contains 17.5 g glucose and 17.5 g fructose representing 35 g completely inverted sucrose	Dietary Supplement: Blackcurrant Nectar
Lingonberry nectar	Experimental	Contains 17.5 g glucose and 17.5 g fructose representing 35 g completely inverted sucrose	Dietary Supplement: Lingonberry Nectar
Reference	Active Comparator	Sugar control, contains 17.5 g glucose and 17.5 g fructose in water	Dietary Supplement: Reference

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Blackcurrant Nectar	Dietary Supplement	Consumption of a single dose (300 ml)	Blackcurrant nectar

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Plasma glucose response	0, 15, 30, 45, 60, 90, 120 minutes post-meal	2 hours

Secondary Outcomes

Measure	Description	Time Frame
Plasma insulin response	0, 15, 30, 45, 60, 90, 120 minutes post-meal	2 hours

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

BMI 20-28 kg/m2
Normal fasting plasma glucose

Exclusion Criteria:

Smoking
Diabetes or other chronic disease
Antibiotic medication within the past 3 months
Blood donation within the past month

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

25 Years

Maximum Age

69 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Riitta Törrönen, Dr	Senior Scientist	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Eastern Finland		Kuopio		FI-70211	Finland

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
D006943	Hyperglycemia

Ancestor Terms

ID	Term
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided