Condition category
Nutritional, Metabolic, Endocrine
Date applied
16/04/2010
Date assigned
27/05/2010
Last edited
27/05/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Leo Niskanen

ORCID ID

Contact details

Neulaniementie 2 L 6
Kuopio
70210
Finland
leo.niskanen@kuh.fi

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

POFE2 4232

Study information

Scientific title

Effect of sucrose-sweetened mixed berry puree on postprandial glucose and insulin response: A randomised, single-blind, placebo-controlled, cross-over single-centre study

Acronym

Study hypothesis

The primary aim was to investigate the effect of mixed berry puree made from bilberries, blackcurrants, cranberries and strawberries on postprandial plasma glucose concentrations after a 35 g sucrose load in healthy subjects. The secondary aim was to investigate the effect of berry puree on postprandial insulin response.

Ethics approval

The Ethics Committee of the Hospital District of Northern Savo approved the study protocol 27 October 2009 (DNRO 106/2009)

Study design

Randomised single blind placebo controlled crossover single centre study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Not available in web format, please use contact details below to request a patient information sheet

Condition

Postprandial glycaemia

Intervention

Test meal: 150 g of berry puree made from equal amounts of bilberries, blackcurrants, cranberries and strawberries with 35 g sucrose and 120 ml of tap water.
Control meal: 250 ml of oral sucrose load with similar amounts of available carbohydrates (glucose, fructose and sucrose) than test meal.

Subjects participated in two 2-h meal tolerance tests in a random order, on separate days, with a washout period of at least 5 days. Subjects were tested at the same time of day under similar conditions and acting as their own controls. The experiment began in the morning after a 10-12 h overnight fast. Subjects were advised to consume the test meal steadily within 15 min.
The study subjects were instructed to maintain their diet, body weight and living habits throughout the study, to refrain from intensive physical activity on the day before the test days and abstain from alcohol two days before the test days, and to avoid berries and chocolate in the prior evening meal. In addition, in the evening before the test day each subject was told to consume a meal of choice and repeat that meal before the second test. Smoking was prohibited on the morning before the test and during the test meal.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Plasma glucose concentrations analysed from fingertip capillary and venous blood samples taken within 20 min before the ingestion of meal and at 15, 30, 45, 60, 90 and 120 min after starting the ingestion of meal.

Secondary outcome measures

1. Serum insulin concentrations analysed from venous blood samples taken within 20 min before the ingestion of meal and at 15, 30, 45, 60, 90 and 120 min after starting the ingestion of meal
2. Optionally, the following concentrations may be measured at the same time points:
2.1. Plasma cholecystokinin (CCK)
2.2. Glucose-dependent insulinotropic polypeptide (GIP)
2.3. Glugacon-like peptide 1 (GLP-1)
2.4. Peptide YY (PYY)
3. Body weight measured with calibrated digital scale at every study visit after 10-12 h overnight fasting

Overall trial start date

28/10/2009

Overall trial end date

03/12/2009

Reason abandoned

Eligibility

Participant inclusion criteria

1. Provision of signed and dated consent prior to any study procedures
2. Men or women aged 18 to 70 years
3. Subject's laboratory evaluation at the screening visit must be within normal limits (with the exception of abnormalities considered as clinically insignificant in the opinion of the study physician)

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

12

Participant exclusion criteria

1. Subject with type 1 diabetes
2. Subject with type 2 diabetes
3. Subject requiring antiglycemic medication
4. Subject with allergy or sensitivity to an ingredient of the test product
5. Subject with active hepatic, kidney or thyroid disease or disorder except the subjects on thyroid replacement therapy
6. Female subject who is pregnant or lactating
7. Subject with: haemoglobin < 100 g / l, fasting plasma glucose concentration > 7.0 mmol/l, plasma gamma-glutamyl transferase > 2 x upper limit of normal or plasma creatinine > 2 x upper limit of normal at the screening visit.
8. Subject with body mass index > 30
9. Subject who have had myocardial infarction within 6 months prior to screening
10. Subject with unstable angina pectoris
11. Subject who have history of temporal ischemic attack or stroke within six months prior to screening
12. Subject with malignancy within 5 years prior screening (except treated cutaneous basal cell or squamous cell cancer)

Recruitment start date

28/10/2009

Recruitment end date

03/12/2009

Locations

Countries of recruitment

Finland

Trial participating centre

Neulaniementie 2 L 6
Kuopio
70210
Finland

Sponsor information

Organisation

Finnsugar Ltd (Finland)

Sponsor details

Sokeritehtaantie 20
Kantvik
02460
Finland
kyllikki.kilpi@nordicsugar.com

Sponsor type

Industry

Website

Funders

Funder type

Industry

Funder name

Finnsugar Ltd (Finland)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes