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NCT Number: NCT05139355

Health Effects of Oat and Oat Polar Lipids in Human

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.

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Key information

Conditions

Postprandial Glucose Regulation

Age range

20 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Food Technology, engineering and Nutrition, LTH, Lund University

Lund, 22100, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Effects of Oat and Oat Components on Cardiometabolic risk variables

Combination Product

Oat and oat bioactive components consumed as breakfast meal.

Primary outcomes

  1. Blood glucose regulation

    Time frame: 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 outcomes

  1. Serum insulin

    Time frame: 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 )

    Time frame: 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

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

    Cardiometabolic risk markers

  4. Serum Free Fatty Acids

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

    Cardiometabolic risk markers

  5. Plasma PYY (peptide tyrosine tyrosine)

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

    Gastro-intestinale hormones involved in appetite and metabolic regulation

Other outcomes

  1. Subjective appetite sensations

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

Lund University

Other

Collaborators

  • Swedish Foundation for Strategic Research

Registry information

Official study title

Health Effects of Oat and Oat Bioactive in Human

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Dec 1, 2021
Registry last updated
Apr 8, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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