NCT05801653

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 P25-P50 for not_applicable healthy

Timeline
Completed

Started Mar 2023

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

March 8, 2023

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

March 24, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

April 6, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 10, 2023

Completed
Last Updated

October 4, 2023

Status Verified

October 1, 2023

Enrollment Period

3 months

First QC Date

March 24, 2023

Last Update Submit

October 3, 2023

Conditions

Healthy

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.

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

Secondary Outcomes (1)

  • Serum insulin

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

Other Outcomes (1)

  • Subjective appetite sensations

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

Study Arms (4)

Oat meal 1

EXPERIMENTAL

The test portion is based on 30 gram available carbohydrates with added x amount oat betaglucan. Test portion consumed as a breakfast meal prior to determinations of test variables in the morning

Dietary Supplement: Effects of Oat and Oat Components on Cardiometabolic risk variables

Oat meal 2

EXPERIMENTAL

The test portion is based on 30 gram available carbohydrates with added y amount of oat betaglucan. Test portion consumed as a breakfast meal prior to determinations of test variables in the morning

Dietary Supplement: Effects of Oat and Oat Components on Cardiometabolic risk variables

Oat meal 3

EXPERIMENTAL

The test portion is based on 30 gram available carbohydrates with added z amount of oat betaglucan. Test portion consumed as a breakfast meal prior to determinations of test variables in the morning

Dietary Supplement: Effects of Oat and Oat Components on Cardiometabolic risk variables

Reference

PLACEBO COMPARATOR

The test portion is based on 30 gram available carbohydrates without added oat betaglucan. Test portion consumed as a breakfast meal prior to determinations of test variables in the morning

Dietary Supplement: Effects of Oat and Oat Components on Cardiometabolic risk variables

Interventions

Effects of Oat and Oat Components on Cardiometabolic risk variablesDIETARY_SUPPLEMENT

Oat and oat bioactive components consumed as breakfast meal.

Oat meal 1Oat meal 2Oat meal 3Reference

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, Skåne County, 22100, Sweden

Location

Study Officials

  • Anne Nilsson

    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

March 24, 2023

First Posted

April 6, 2023

Study Start

March 8, 2023

Primary Completion

June 15, 2023

Study Completion

August 10, 2023

Last Updated

October 4, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Raw data

Locations

SE(1)