NCT04150926

Brief Summary

The study examines the effect of black currant on glucose and insulin concentrations after a meal. In addition, the cytokine and free fatty acids levels are of interest.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
26

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2019

Shorter than P25 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

August 15, 2019

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

November 1, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 5, 2019

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2020

Completed
Last Updated

September 4, 2020

Status Verified

September 1, 2020

Enrollment Period

7 months

First QC Date

November 1, 2019

Last Update Submit

September 3, 2020

Conditions

Keywords

berriesblack currantglucoseglycemiaquinoa

Outcome Measures

Primary Outcomes (2)

  • Glucose concentration

    Glucose concentration after meal

    0 minutes until 180 minutes

  • Insulin concentration

    Insulin concentration after meal

    0 minutes until 180 minutes

Study Arms (4)

Black currant puree

EXPERIMENTAL

Black currant puree

Other: Black currant

Black currant-quinoa product

ACTIVE COMPARATOR

Black currant-quinoa product

Other: Black currant-quinoa product

Quinoa base

ACTIVE COMPARATOR

Quinoa base is used for the black currant-quinoa product.

Other: Quinoa base

Liquid with glucose, fructose and sucrose

NO INTERVENTION

Liquid with glucose, fructose and sucrose

Interventions

The effect of black currant puree will be compared with black currant-quinoa product, quinoa base and with liquid with glucose, fructose and sucrose Experimental: Black currant and quinoa product Active Comparator: Quinoa base Meal study comparing the effect of black currant puree with liquid with glucose, fructose and sucrose, black currant and quinoa product and quinoa base

Black currant puree

The effect of black currant puree will be compared with black currant-quinoa product

Black currant-quinoa product

The effect of black currant puree will be compared with quinoa base

Quinoa base

Eligibility Criteria

Age25 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • age: 25-65 years
  • BMI: 20-28 kg/m2
  • Perceived health status: Good

You may not qualify if:

  • fasting glucose: \> 7.0 mmol/l
  • LDL-cholesterol: \> 3.0 mmol/l
  • total cholesterol: \> 6.5 mmol/l
  • blood pressure : \> 160/100 mmHg
  • weight change of \> 5% during previous 6 months or active weightreduction
  • no serious chronic diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Eastern Finland

Kuopio, 70211, Finland

Location

MeSH Terms

Conditions

HyperglycemiaPrediabetic State

Interventions

black currant oil

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesDiabetes MellitusEndocrine System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Products are visibly differing from each other.
Purpose
PREVENTION
Intervention Model
CROSSOVER
Model Details: Meal studies in randomised order
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 1, 2019

First Posted

November 5, 2019

Study Start

August 15, 2019

Primary Completion

February 28, 2020

Study Completion

April 30, 2020

Last Updated

September 4, 2020

Record last verified: 2020-09

Data Sharing

IPD Sharing
Will not share

Anonymised data maybe shared in the future.

Locations