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Completed

NCT Number: NCT02940080

Effect of Anthocyanins Extracted From Purple Potatoes on Healthy Study Subjects' Postprandial Glycemia and Insulinemia

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.

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Key information

Conditions

Postprandial Glycemia

Age range

18 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Department of Biochemistry, University of Turku

Turku, 20014, Finland

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dietary

Other

Primary outcomes

  1. Plasma glucose concentration

    Time frame: 0min, 20min, 40min, 60min, 90min, 120min, 180min, 240min

  2. Plasma insulin concentration

    Time frame: 0min, 20min, 40min, 60min, 90min, 120min, 180min, 240min

Secondary outcomes

  1. Concentrations and quality of metabolites and flavonoid color compounds and their metabolites in plasma (NMR and (U)HPLC-MS/MS measurements)

    Time frame: 0min, 20min, 40min, 60min, 90min, 120min, 180min, 240min

  2. Concentrations and quality of metabolites and flavonoid color compounds and their metabolites in urine (NMR and (U)HPLC-MS/MS measurements)

    Time frame: Before meal, and 0-4h, 4-8h, 8-16h, 16-24 h

  3. Concentrations and quality of metabolites and flavonoid color compounds and their metabolites in feces (NMR and (U)HPLC-MS/MS measurements)

    Time frame: before and after meal

  4. Area under the glucose concentration curve (AUC)

    Time frame: 0min, 20min, 40min, 60min, 90min, 120min, 180min, 240min

  5. Area under the insulin concentration curve (AUC)

    Time frame: 0min, 20min, 40min, 60min, 90min, 120min, 180min, 240min

Sponsors and collaborators

Lead sponsor

University of Turku

Other

Registry information

Important dates

Study start
2016
Primary completion
2021
Study completion
2021
First posted
Oct 20, 2016
Registry last updated
Mar 14, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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