NCT05139355

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 Nov 2021

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

November 16, 2021

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

November 17, 2021

Completed
14 days until next milestone

First Posted

Study publicly available on registry

December 1, 2021

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 26, 2022

Completed
17 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2022

Completed
Last Updated

April 8, 2022

Status Verified

April 1, 2022

Enrollment Period

3 months

First QC Date

November 17, 2021

Last Update Submit

April 7, 2022

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 (5)

  • 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)

  • Serum triglycerides

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

  • Serum Free Fatty Acids

    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)

Other Outcomes (1)

  • Subjective appetite sensations

    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 C. 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.

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 Kg/m2
  • Non smokers
  • Consuming a non-vegetarian diet that follows the Nordic diet recommendation.

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.
  • 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

Related Publications (1)

  • Hossain MM, Tovar J, Cloetens L, de Kam S, Nilsson A. Oat polar lipids and sunflower lecithin similarly improve cardiometabolic risk markers and appetite controlling hormone responses after breakfast and a subsequent lunch. A randomized crossover study in healthy adults. Front Nutr. 2024 Nov 6;11:1497844. doi: 10.3389/fnut.2024.1497844. eCollection 2024.

    PMID: 39568724DERIVED

Study Officials

  • Anne Nilsson, PhD

    Department of Food Technology, Engineering and Nutrition, Lund Univesity

    PRINCIPAL INVESTIGATOR

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

November 17, 2021

First Posted

December 1, 2021

Study Start

November 16, 2021

Primary Completion

February 26, 2022

Study Completion

March 15, 2022

Last Updated

April 8, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will not share

Locations

SE(1)