NCT01580150

Brief Summary

The purpose of this study is to investigate whether berries are effective in lowering blood glucose and insulin responses to meals containing starch or sucrose.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2009

Typical duration 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

November 1, 2009

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2012

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 16, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 18, 2012

Completed
Last Updated

April 18, 2012

Status Verified

April 1, 2012

Enrollment Period

2.2 years

First QC Date

April 16, 2012

Last Update Submit

April 16, 2012

Conditions

Keywords

BerriesStarchSucroseGlucoseInsulinPostprandial

Outcome Measures

Primary Outcomes (2)

  • Plasma glucose

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

  • Plasma insulin

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

Secondary Outcomes (1)

  • Plasma free fatty acids

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

Study Arms (2)

Berry meal

EXPERIMENTAL

Carbohydrate meals with berries

Other: Berries

Reference meal

ACTIVE COMPARATOR

Carbohydrate meals without berries

Other: No berries

Interventions

BerriesOTHER

Meals containing starch (bread) or sucrose are consumed with berries (150 g) or berry nectars (300 mL).

Berry meal

Meals containing starch (bread) or sucrose are consumed without berries.

Reference meal

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

Related Publications (2)

  • Torronen R, Kolehmainen M, Sarkkinen E, Poutanen K, Mykkanen H, Niskanen L. Berries reduce postprandial insulin responses to wheat and rye breads in healthy women. J Nutr. 2013 Apr;143(4):430-6. doi: 10.3945/jn.112.169771. Epub 2013 Jan 30.

  • Torronen R, Kolehmainen M, Sarkkinen E, Mykkanen H, Niskanen L. Postprandial glucose, insulin, and free fatty acid responses to sucrose consumed with blackcurrants and lingonberries in healthy women. Am J Clin Nutr. 2012 Sep;96(3):527-33. doi: 10.3945/ajcn.112.042184. Epub 2012 Aug 1.

MeSH Terms

Conditions

HyperglycemiaInsulin Resistance

Interventions

Fruit

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesHyperinsulinism

Intervention Hierarchy (Ancestors)

FoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Riitta Törrönen, Dr

    Senior Scientist

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Senior scientist

Study Record Dates

First Submitted

April 16, 2012

First Posted

April 18, 2012

Study Start

November 1, 2009

Primary Completion

January 1, 2012

Study Completion

January 1, 2012

Last Updated

April 18, 2012

Record last verified: 2012-04

Locations