NCT02005796

Brief Summary

In this study, the postprandial glycemia and insulinemia caused by boiled potato with blue-fleshed or yellow-fleshed tubers, or a gel prepared with bilberries and potato starch, is studied in healthy males. Additionally, the appearance and metabolism of the flavonoids and their metabolites is studied in plasma and urine.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
14

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2013

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2013

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

December 3, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 9, 2013

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed
Last Updated

May 20, 2015

Status Verified

May 1, 2015

Enrollment Period

1.4 years

First QC Date

December 3, 2013

Last Update Submit

May 19, 2015

Conditions

Outcome Measures

Primary Outcomes (2)

  • Plasma glucose concentration

    20min, 40min, 60min, 90min, 120min, 180min, 240min

  • Plasma insulin concentration

    20min, 40min, 60min, 90min, 120min, 180min, 240min

Secondary Outcomes (2)

  • Concentrations and quality of flavonoid color compounds or their metabolites in plasma and urine (HPLC-measurement)

    20min, 40min, 60min, 90min, 120min, 180min, 240min

  • Concentrations and quality of flavonoid color compounds or their metabolites in plasma and urine (NMR-measurement)

    20min, 40min, 60min, 90min, 120min, 180min, 240min

Study Arms (3)

Blue-fleshed potato tubers

EXPERIMENTAL

Intervention: Steam cooked mashed potato tubers

Other: Dietary intervention

Yellow-fleshed potato tubers

EXPERIMENTAL

Intervention: Steam cooked mashed potato tubers

Other: Dietary intervention

Bilberries and potato starch

EXPERIMENTAL

Intervention: A gel boiled with bilberries and potato starch

Other: Dietary intervention

Interventions

Bilberries and potato starchBlue-fleshed potato tubersYellow-fleshed potato tubers

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

University of Turku, Turku, 20014, Finland

Location

MeSH Terms

Interventions

Diet Therapy

Intervention Hierarchy (Ancestors)

Nutrition TherapyTherapeutics

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
PhD

Study Record Dates

First Submitted

December 3, 2013

First Posted

December 9, 2013

Study Start

December 1, 2013

Primary Completion

May 1, 2015

Study Completion

May 1, 2015

Last Updated

May 20, 2015

Record last verified: 2015-05

Locations