Effect of sucrose-sweetened mixed berry puree on postprandial glucose and insulin response

ISRCTN	ISRCTN03619857
DOI	https://doi.org/10.1186/ISRCTN03619857
Secondary identifying numbers	POFE2 4232

Submission date: 16/04/2010
Registration date: 27/05/2010
Last edited: 27/05/2010

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Nutritional, Metabolic, Endocrine

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Leo Niskanen
Scientific

Neulaniementie 2 L 6
Kuopio
70210
Finland

Email	leo.niskanen@kuh.fi

Study information

Study design	Randomised single blind placebo controlled crossover single centre study
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Other
Study type	Treatment
Participant information sheet	Not available in web format, please use contact details below to request a patient information sheet
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
Study objectives	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(s)	The Ethics Committee of the Hospital District of Northern Savo approved the study protocol 27 October 2009 (DNRO 106/2009)
Health condition(s) or problem(s) studied	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
Primary outcome measure	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 study start date	28/10/2009
Completion date	03/12/2009

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	12
Key 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)
Key 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)
Date of first enrolment	28/10/2009
Date of final enrolment	03/12/2009

Locations

Countries of recruitment

Finland

Study participating centre

Neulaniementie 2 L 6

Kuopio
70210
Finland

Sponsor information

Finnsugar Ltd (Finland)
Industry

Sokeritehtaantie 20
Kantvik
02460
Finland

Email	kyllikki.kilpi@nordicsugar.com
"ROR"	https://ror.org/02cnwya81

Funders

Funder type

Industry

Finnsugar Ltd (Finland)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan