NCT02743130

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2014

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

September 1, 2014

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2014

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

April 14, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 19, 2016

Completed
Last Updated

April 19, 2016

Status Verified

April 1, 2016

Enrollment Period

2 months

First QC Date

April 14, 2016

Last Update Submit

April 14, 2016

Conditions

Hyperglycemia, Postprandial

Keywords

BerriesBlackcurrant (Ribes nigrum)Lingonberry (Vaccinium vitis-idaea)SucroseInverted sugarPostprandial glucose responsePostprandial insulin response

Outcome Measures

Primary Outcomes (1)

  • Plasma glucose response

    0, 15, 30, 45, 60, 90, 120 minutes post-meal

    2 hours

Secondary Outcomes (1)

  • Plasma insulin response

    2 hours

Study Arms (3)

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

Blackcurrant NectarDIETARY_SUPPLEMENT

Consumption of a single dose (300 ml)

Blackcurrant nectar
Lingonberry NectarDIETARY_SUPPLEMENT

Consumption of a single dose (300 ml)

Lingonberry nectar
ReferenceDIETARY_SUPPLEMENT

Consumption of a single dose (300 ml)

Reference

Eligibility Criteria

Age25 Years - 69 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • BMI 20-28 kg/m2
  • Normal fasting plasma glucose

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Eastern Finland

Kuopio, FI-70211, Finland

Location

MeSH Terms

Conditions

Hyperglycemia

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Riitta Törrönen, Dr

    Senior Scientist

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Scientist

Study Record Dates

First Submitted

April 14, 2016

First Posted

April 19, 2016

Study Start

September 1, 2014

Primary Completion

November 1, 2014

Study Completion

November 1, 2014

Last Updated

April 19, 2016

Record last verified: 2016-04

Data Sharing

IPD Sharing
Will not share

Locations

FI(1)