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

March 11, 2022 updated by: Kaisa Linderborg, University of Turku
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

18

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Finland
      • Turku, Finland, 20014
        • Department of Biochemistry, University of Turku

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Anthocyanins and yellow potato
168 mg of anthocyanins extracted from purple-fleshed potatoes added to 350 g of steam-cooked mashed potatoes in water
Other: Dietary
Experimental: Yellow potato
350 g of steam-cooked mashed potatoes in water
Other: Dietary

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Plasma glucose concentration
Time Frame: 0min, 20min, 40min, 60min, 90min, 120min, 180min, 240min
0min, 20min, 40min, 60min, 90min, 120min, 180min, 240min
Plasma insulin concentration
Time Frame: 0min, 20min, 40min, 60min, 90min, 120min, 180min, 240min
0min, 20min, 40min, 60min, 90min, 120min, 180min, 240min

Secondary Outcome Measures

Outcome Measure
Time Frame
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
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)
Time Frame: Before meal, and 0-4h, 4-8h, 8-16h, 16-24 h
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)
Time Frame: before and after meal
before and after meal
Area under the glucose concentration curve (AUC)
Time Frame: 0min, 20min, 40min, 60min, 90min, 120min, 180min, 240min
0min, 20min, 40min, 60min, 90min, 120min, 180min, 240min
Area under the insulin concentration curve (AUC)
Time Frame: 0min, 20min, 40min, 60min, 90min, 120min, 180min, 240min
0min, 20min, 40min, 60min, 90min, 120min, 180min, 240min

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Turku

Investigators

  • Principal Investigator: Kaisa M Linderborg, PhD, Department of Biochemistry, University of Turku

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2016

Primary Completion (Actual)

December 31, 2021

Study Completion (Actual)

December 31, 2021

Study Registration Dates

First Submitted

October 13, 2016

First Submitted That Met QC Criteria

October 18, 2016

First Posted (Estimate)

October 20, 2016

Study Record Updates

Last Update Posted (Actual)

March 14, 2022

Last Update Submitted That Met QC Criteria

March 11, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • Siniset perunat 2

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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