Effect of Anthocyanins Extracted From Purple Potatoes on Healthy Study Subjects' Postprandial Glycemia and Insulinemia
1 other identifier
interventional
18
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Oct 2016
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2016
CompletedFirst Submitted
Initial submission to the registry
October 13, 2016
CompletedFirst Posted
Study publicly available on registry
October 20, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2021
CompletedMarch 14, 2022
March 1, 2022
5.3 years
October 13, 2016
March 11, 2022
Conditions
Outcome Measures
Primary Outcomes (2)
Plasma glucose concentration
0min, 20min, 40min, 60min, 90min, 120min, 180min, 240min
Plasma insulin concentration
0min, 20min, 40min, 60min, 90min, 120min, 180min, 240min
Secondary Outcomes (5)
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
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
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
Area under the glucose concentration curve (AUC)
0min, 20min, 40min, 60min, 90min, 120min, 180min, 240min
Area under the insulin concentration curve (AUC)
0min, 20min, 40min, 60min, 90min, 120min, 180min, 240min
Study Arms (2)
Anthocyanins and yellow potato
EXPERIMENTAL168 mg of anthocyanins extracted from purple-fleshed potatoes added to 350 g of steam-cooked mashed potatoes in water
Yellow potato
EXPERIMENTAL350 g of steam-cooked mashed potatoes in water
Interventions
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- Regular smoking
- Alcohol abuse
- Regular medication
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Biochemistry, University of Turku
Turku, 20014, Finland
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kaisa M Linderborg, PhD
Department of Biochemistry, University of Turku
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
October 13, 2016
First Posted
October 20, 2016
Study Start
October 1, 2016
Primary Completion
December 31, 2021
Study Completion
December 31, 2021
Last Updated
March 14, 2022
Record last verified: 2022-03