NCT04542265

Brief Summary

Aim of the study is to investigate health effects of oats and oat derived components, in human intervention studies, with the purpose to build new knowledge for development of cardiometabolic protective foods

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2020

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 28, 2020

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

September 4, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 9, 2020

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 18, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 18, 2020

Completed
Last Updated

February 8, 2021

Status Verified

February 1, 2021

Enrollment Period

4 months

First QC Date

September 4, 2020

Last Update Submit

February 5, 2021

Conditions

Postprandial Glucose Regulation

Outcome Measures

Primary Outcomes (1)

  • Blood glucose regulation

    Postprandial blood glucose regulation (incremental area under the curve) acute after intake of the test products and at forthcoming meals within 5.5 hours after consumption of test products.

    0 - 5.5 hours ( at fasting and then repeatedly after breakfast and Standardize lunch)

Secondary Outcomes (6)

  • Serum insulin

    0 - 5.5 hours ( at fasting and then repeatedly after breakfast and Standardize lunch)

  • plasma GLP-1 (glucagon-like peptide-1 )

    0 - 5.5 hours ( at fasting and then repeatedly after breakfast and Standardize lunch)

  • Plasma PYY (peptide tyrosine tyrosine)

    0 - 5.5 hours ( at fasting and then repeatedly after breakfast and Standardize lunch)

  • IL (interleukin)-6

    0 - 5.5 hours ( at fasting and then repeatedly after breakfast and Standardize lunch)

  • Serum triglycerides

    0 - 5.5 hours ( at fasting and then repeatedly after breakfast and Standardize lunch)

  • +1 more secondary outcomes

Other Outcomes (2)

  • Subjective appetite sensations

    0 - 5.5 hours ( at fasting and then repeatedly after breakfast and Standardize lunch)

  • Mood (valence and activity)

    0 - 5.5 hours ( at fasting and then repeatedly after breakfast and Standardize lunch)

Study Arms (4)

Oat product 1

EXPERIMENTAL

The test portion is based on 50 gram available carbohydrates with added vegetable oil A. Test portion consumed as a breakfast meal prior to determinations of test variables in the morning.

Combination Product: Effects of Oat and Oat Components on Cardiometabolic risk variables

Oat product 2

EXPERIMENTAL

The test portion is based on 50 gram available carbohydrates with added vegetable oil B. Test portion consumed as a breakfast meal prior to determinations of test variables in the morning.

Combination Product: Effects of Oat and Oat Components on Cardiometabolic risk variables

Oat product 3

EXPERIMENTAL

The test portion is based on 50 gram available carbohydrates with added vegetable oil A + vegetable oil B. Test portion consumed as a breakfast meal prior to determinations of test variables in the morning.

Combination Product: Effects of Oat and Oat Components on Cardiometabolic risk variables

Control Product

PLACEBO COMPARATOR

The test portion is based on 50 gram available carbohydrates without added vegetable oil. Test portion consumed as a breakfast meal prior to determinations of test variables in the morning.

Combination Product: Effects of Oat and Oat Components on Cardiometabolic risk variables

Interventions

Effects of Oat and Oat Components on Cardiometabolic risk variablesCOMBINATION_PRODUCT

Oat and oat bioactive components consumed as breakfast meal.

Control ProductOat product 1Oat product 2Oat product 3

Eligibility Criteria

Age20 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • healthy adults
  • BMI 18,5 - 28
  • non smokers
  • consuming a non-vegetarian diet that follows the Nordic guidances

You may not qualify if:

  • Fasting blood glucose concentration \>6.1 mmol/l
  • Known cardio-metabolic disease (e.g. diabetes, hypertension, metabolic syndrome), gastro-intestinal disorders such as IBS (irritable bowel syndrome) that can interfere with the study results, food allergies. Further no antibiotics or probiotics should have been consumed within 4 weeks prior to and during the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Food Technology, engineering and Nutrition, LTH, Lund University

Lund, 22100, Sweden

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 4, 2020

First Posted

September 9, 2020

Study Start

August 28, 2020

Primary Completion

December 18, 2020

Study Completion

December 18, 2020

Last Updated

February 8, 2021

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will not share

Locations

SE(1)