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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02940080
Other study ID # Siniset perunat 2
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 2016
Est. completion date December 31, 2021

Study information

Verified date March 2022
Source University of Turku
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

A randomized, single-blind cross-over clinical nutrition trial will be conducted. The effects of yellow-fleshed potatoes and yellow-fleshed potatoes supplemented with anthocyanins extracted from purple-fleshed potatoes on healthy men's postprandial glycemia and insulinemia will be compared. Additionally, the postprandial metabolism and metabolites, and the appearance and metabolism of the flavonoids and their metabolites is studied in plasma, urine and feces.


Recruitment information / eligibility

Status Completed
Enrollment 18
Est. completion date December 31, 2021
Est. primary completion date December 31, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years to 45 Years
Eligibility Inclusion Criteria: - Age 18-45 - Male - No regular medication - No participation in a drug trial or blood donation within 2 months - Non-smoker - Signs informed consent - Body mass index 18.5-27 kg/m2 - Fasting plasma cholesterol < 5.5 mmol/l - Fasting plasma triacylglycerols < 2.6 mmol/l - Fasting plasma glucose 4-6 mmol/l - blood pressure <140/80 mmHg - hemoglobin>130 g/l - Fasting plasma alanine amino transferase (ALAT) <60 U/l (normal liver function) - Fasting plasma thyroid-stimulating hormone (TSH) 0.4 - 4.5 mU/l (normal thyroid function) - Fasting plasma creatinine <118 µmol/l (normal kidney function) Exclusion Criteria: - Regular smoking - Alcohol abuse - Regular medication

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Dietary


Locations

Country Name City State
Finland Department of Biochemistry, University of Turku Turku

Sponsors (1)

Lead Sponsor Collaborator
University of Turku

Country where clinical trial is conducted

Finland, 

Outcome

Type Measure Description Time frame Safety issue
Primary Plasma glucose concentration 0min, 20min, 40min, 60min, 90min, 120min, 180min, 240min
Primary Plasma insulin concentration 0min, 20min, 40min, 60min, 90min, 120min, 180min, 240min
Secondary Concentrations and quality of metabolites and flavonoid color compounds and their metabolites in plasma (NMR and (U)HPLC-MS/MS measurements) 0min, 20min, 40min, 60min, 90min, 120min, 180min, 240min
Secondary Concentrations and quality of metabolites and flavonoid color compounds and their metabolites in urine (NMR and (U)HPLC-MS/MS measurements) Before meal, and 0-4h, 4-8h, 8-16h, 16-24 h
Secondary Concentrations and quality of metabolites and flavonoid color compounds and their metabolites in feces (NMR and (U)HPLC-MS/MS measurements) before and after meal
Secondary Area under the glucose concentration curve (AUC) 0min, 20min, 40min, 60min, 90min, 120min, 180min, 240min
Secondary Area under the insulin concentration curve (AUC) 0min, 20min, 40min, 60min, 90min, 120min, 180min, 240min
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