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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01580150
Other study ID # 247032
Secondary ID 70035/09, 1087/3
Status Completed
Phase N/A
First received April 16, 2012
Last updated April 16, 2012
Start date November 2009
Est. completion date January 2012

Study information

Verified date April 2012
Source University of Eastern Finland
Contact n/a
Is FDA regulated No
Health authority Finland: Ethics Committee
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 20
Est. completion date January 2012
Est. primary completion date January 2012
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 25 Years to 69 Years
Eligibility 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 Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science


Intervention

Other:
Berries
Meals containing starch (bread) or sucrose are consumed with berries (150 g) or berry nectars (300 mL).
No berries
Meals containing starch (bread) or sucrose are consumed without berries.

Locations

Country Name City State
Finland University of Eastern Finland Kuopio

Sponsors (1)

Lead Sponsor Collaborator
Marjukka Kolehmainen

Country where clinical trial is conducted

Finland, 

Outcome

Type Measure Description Time frame Safety issue
Primary Plasma glucose 0, 15, 30, 45, 60, 90, 120 minutes post-meal No
Primary Plasma insulin 0, 15, 30, 45, 60, 90, 120 minutes post-meal No
Secondary Plasma free fatty acids 0, 15, 30, 45, 60, 90, 120 minutes post-meal No
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