NCT02940080

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2016

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

October 13, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 20, 2016

Completed
5.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

March 14, 2022

Status Verified

March 1, 2022

Enrollment Period

5.3 years

First QC Date

October 13, 2016

Last Update Submit

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

EXPERIMENTAL

168 mg of anthocyanins extracted from purple-fleshed potatoes added to 350 g of steam-cooked mashed potatoes in water

Other: Dietary

Yellow potato

EXPERIMENTAL

350 g of steam-cooked mashed potatoes in water

Other: Dietary

Interventions

DietaryOTHER
Anthocyanins and yellow potatoYellow potato

Eligibility Criteria

Age18 Years - 45 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

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

Location

MeSH Terms

Interventions

Diet

Intervention Hierarchy (Ancestors)

Nutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological Phenomena

Study Officials

  • Kaisa M Linderborg, PhD

    Department of Biochemistry, University of Turku

    PRINCIPAL INVESTIGATOR

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

Locations