Clinical trial NCT02940080: Effect of Anthocyanins Extracted From Purple Potatoes on Healthy Study Subjects' Postprandial Glycemia and Insulinemia
Official title: Effect of Anthocyanins Extracted From Purple Potatoes on Healthy Study Subjects' Postprandial Glycemia and Insulinemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postprandial Glycemia
Lead sponsor: University of Turku
Sponsor class: OTHER
First posted: 2016-10-20
Enrollment: 18
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Plasma glucose concentration
timeFrame: 0min, 20min, 40min, 60min, 90min, 120min, 180min, 240min
measure: Plasma insulin concentration
timeFrame: 0min, 20min, 40min, 60min, 90min, 120min, 180min, 240min
Secondary outcomes:
measure: Concentrations and quality of metabolites and flavonoid color compounds and their metabolites in plasma (NMR and (U)HPLC-MS/MS measurements)
timeFrame: 0min, 20min, 40min, 60min, 90min, 120min, 180min, 240min
measure: Concentrations and quality of metabolites and flavonoid color compounds and their metabolites in urine (NMR and (U)HPLC-MS/MS measurements)
timeFrame: Before meal, and 0-4h, 4-8h, 8-16h, 16-24 h
measure: Concentrations and quality of metabolites and flavonoid color compounds and their metabolites in feces (NMR and (U)HPLC-MS/MS measurements)
timeFrame: before and after meal
measure: Area under the glucose concentration curve (AUC)
timeFrame: 0min, 20min, 40min, 60min, 90min, 120min, 180min, 240min
measure: Area under the insulin concentration curve (AUC)
timeFrame: 0min, 20min, 40min, 60min, 90min, 120min, 180min, 240min
Other outcomes:
Locations:
city: Turku
country: Finland
facility: Department of Biochemistry, University of Turku
Study officials:
affiliation: Department of Biochemistry, University of Turku
name: Kaisa M Linderborg, PhD
role: PRINCIPAL_INVESTIGATOR
References: