Health Effects of Oat and Oat Polar Lipids in Human

Sponsor
Lund University (Other)
Overall Status
Completed
CT.gov ID
NCT05139355
Collaborator
Swedish Foundation for Strategic Research (Other)
20
1
4
3.9
5.1

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Combination Product: Effects of Oat and Oat Components on Cardiometabolic risk variables
N/A

Detailed Description

The overall goal is to increase the knowledge which can be used for the development of food products with anti-diabetic properties, with the purpose to facilitate healthier food choices for people. More specifically the primary purpose of this project is to evaluate effects in healthy humans on cardiometabolic test markers of oat and oat based product. The new knowledge will form a base for the development of oat based food products with added health values.

Study Design

Study Type:
Interventional
Actual Enrollment :
20 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Single (Participant)
Primary Purpose:
Prevention
Official Title:
Health Effects of Oat and Oat Bioactive in Human
Actual Study Start Date :
Nov 16, 2021
Actual Primary Completion Date :
Feb 26, 2022
Actual Study Completion Date :
Mar 15, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Oat product 1

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 and oat bioactive components consumed as breakfast meal.

Experimental: Oat product 2

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 and oat bioactive components consumed as breakfast meal.

Experimental: Oat product 3

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
Oat and oat bioactive components consumed as breakfast meal.

Placebo Comparator: Control Product

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
Oat and oat bioactive components consumed as breakfast meal.

Outcome Measures

Primary Outcome Measures

  1. Blood glucose regulation [0 - 5.5 hours ( at fasting and then repeatedly after breakfast and Standardize lunch)]

    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.

Secondary Outcome Measures

  1. Serum insulin [0 - 5.5 hours ( at fasting and then repeatedly after breakfast and Standardize lunch)]

    Acute effects of postprandial serum insulin concentrations (incremental area under the curve) after intake of the test products.

  2. plasma GLP-1 (glucagon-like peptide-1 ) [0 - 5.5 hours ( at fasting and then repeatedly after breakfast and Standardize lunch)]

    Gastro-intestinale hormones involved in appetite and metabolic regulation

  3. Serum triglycerides [0 - 5.5 hours ( at fasting and then repeatedly after breakfast and Standardize lunch)]

    Cardiometabolic risk markers

  4. Serum Free Fatty Acids [0 - 5.5 hours ( at fasting and then repeatedly after breakfast and Standardize lunch)]

    Cardiometabolic risk markers

  5. Plasma PYY (peptide tyrosine tyrosine) [0 - 5.5 hours ( at fasting and then repeatedly after breakfast and Standardize lunch)]

    Gastro-intestinale hormones involved in appetite and metabolic regulation

Other Outcome Measures

  1. Subjective appetite sensations [0 - 5.5 hours ( at fasting and then repeatedly after breakfast and Standardize lunch)]

    Determined with VAS (visual analogue scale) scales (0-100 mm) as a range of subjective sensations related to appetite (such as hunger, desire to eat or fullness)

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 40 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • Healthy adults

  • BMI 18.5 - 28 Kg/m2

  • Non smokers

  • Consuming a non-vegetarian diet that follows the Nordic diet recommendation.

Exclusion Criteria:
  • 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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Food Technology, engineering and Nutrition, LTH, Lund University Lund Sweden 22100

Sponsors and Collaborators

  • Lund University
  • Swedish Foundation for Strategic Research

Investigators

  • Principal Investigator: Anne Nilsson, PhD, Department of Food Technology, Engineering and Nutrition, Lund Univesity

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Lund University
ClinicalTrials.gov Identifier:
NCT05139355
Other Study ID Numbers:
  • Dnr. 2018/658
First Posted:
Dec 1, 2021
Last Update Posted:
Apr 8, 2022
Last Verified:
Apr 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Apr 8, 2022