Effects of Berries on Post-meal Blood Sugar (SOMA)

April 16, 2012 updated by: Marjukka Kolehmainen

Effects of Berries on Postprandial Glycemic Responses to Sucrose and Starch

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Berries are rich sources of various polyphenols which may be beneficial in the regulation of blood glucose. In vitro and animal studies have shown that polyphenols and polyphenol-rich extracts of foods, including berries, may inhibit digestion and absorption of carbohydrates and thereby suppress postprandial glycemia. However, current evidence on the effects of berries on postprandial glycemic responses in humans is limited.

The purpose of this study is to investigate the effects of berries on postprandial glycemic responses (blood glucose and insulin) to starch or sucrose in healthy subjects. It consists of five substudies each of which includes 2-4 meals with different berry species typically consumed in Finland and a reference meal without berries. The following combinations of carbohydrates and berries are studied:

  • Studies 1-2: white wheat bread (starch) is consumed with several berry species
  • Study 3: white wheat bread or rye bread is consumed with a mixture of berries
  • Study 4: sugar (sucrose) is consumed with berries and berry nectars
  • Study 5: a sugar-sweetened bakery product (starch + sucrose) is consumed with berries and berry nectar.

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Finland
      • Kuopio, Finland, FI-70211
        • University of Eastern Finland

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 69 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Berry meal
Carbohydrate meals with berries
Other: Berries
Meals containing starch (bread) or sucrose are consumed with berries (150 g) or berry nectars (300 mL).
ACTIVE_COMPARATOR: Reference meal
Carbohydrate meals without berries
Other: No berries
Meals containing starch (bread) or sucrose are consumed without berries.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Plasma glucose
Time Frame: 0, 15, 30, 45, 60, 90, 120 minutes post-meal
0, 15, 30, 45, 60, 90, 120 minutes post-meal
Plasma insulin
Time Frame: 0, 15, 30, 45, 60, 90, 120 minutes post-meal
0, 15, 30, 45, 60, 90, 120 minutes post-meal

Secondary Outcome Measures

Outcome Measure
Time Frame
Plasma free fatty acids
Time Frame: 0, 15, 30, 45, 60, 90, 120 minutes post-meal
0, 15, 30, 45, 60, 90, 120 minutes post-meal

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Marjukka Kolehmainen

Investigators

  • Principal Investigator: Riitta Törrönen, Dr, Senior Scientist

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2009

Primary Completion (ACTUAL)

January 1, 2012

Study Completion (ACTUAL)

January 1, 2012

Study Registration Dates

First Submitted

April 16, 2012

First Submitted That Met QC Criteria

April 16, 2012

First Posted (ESTIMATE)

April 18, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

April 18, 2012

Last Update Submitted That Met QC Criteria

April 16, 2012

Last Verified

April 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 247032
  • 70035/09, 1087/31/2009 (OTHER_GRANT: Tekes)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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