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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Marjukka Kolehmainen, University of Eastern Finland
ClinicalTrials.gov Identifier:
NCT01580150
First received: April 16, 2012
Last updated: NA
Last verified: April 2012
History: No changes posted
  Purpose

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.


Condition Intervention
Blood Glucose, Postprandial
Blood Insulin, Postprandial
Hyperglycemia
Other: Berries
Other: No berries

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Effects of Berries on Postprandial Glycemic Responses to Sucrose and Starch

Resource links provided by NLM:


Further study details as provided by University of Eastern Finland:

Primary Outcome Measures:
  • Plasma glucose [ Time Frame: 0, 15, 30, 45, 60, 90, 120 minutes post-meal ] [ Designated as safety issue: No ]
  • Plasma insulin [ Time Frame: 0, 15, 30, 45, 60, 90, 120 minutes post-meal ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Plasma free fatty acids [ Time Frame: 0, 15, 30, 45, 60, 90, 120 minutes post-meal ] [ Designated as safety issue: No ]

Enrollment: 20
Study Start Date: November 2009
Study Completion Date: January 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.
  Eligibility

Ages Eligible for Study:   25 Years to 69 Years
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01580150

Locations
Finland
University of Eastern Finland
Kuopio, Finland, FI-70211
Sponsors and Collaborators
Marjukka Kolehmainen
Investigators
Principal Investigator: Riitta Törrönen, Dr Senior Scientist
  More Information

No publications provided by University of Eastern Finland

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Marjukka Kolehmainen, Senior scientist, University of Eastern Finland
ClinicalTrials.gov Identifier: NCT01580150     History of Changes
Other Study ID Numbers: 247032, 70035/09, 1087/31/2009
Study First Received: April 16, 2012
Last Updated: April 16, 2012
Health Authority: Finland: Ethics Committee

Keywords provided by University of Eastern Finland:
Berries
Starch
Sucrose
Glucose
Insulin
Postprandial

Additional relevant MeSH terms:
Hyperglycemia
Glucose Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on July 29, 2014