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Health Effects of Oats and Oat Bioactive in Human

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03830736
Recruitment Status : Completed
First Posted : February 5, 2019
Last Update Posted : May 1, 2020
Sponsor:
Collaborator:
Swedish Foundation for Strategic Research
Information provided by (Responsible Party):
Anne Nilsson, Lund University

Study Description
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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
Postprandial Glucose Regulation Combination Product: Oat Beverage 1 Combination Product: Oat Beverage 2 Combination Product: Oat Beverage 3 Combination Product: Oat Beverage 4 Combination Product: Control product Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: a randomized blinded cross-over study
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: Effects of Oat and Oat Components on Cardiometabolic- and Cognitive Test Variables
Actual Study Start Date : February 18, 2019
Actual Primary Completion Date : May 30, 2019
Actual Study Completion Date : December 30, 2019
Arms and Interventions
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Arm Intervention/treatment
Placebo Comparator: Control product
A glucose solution (glucose and water) based on 42 gram carbohydrates.
 Combination Product: Control product
Glucose based beverage without added test components is used as control product
Experimental: Oat Beverage 1
The test product is an oat based beverage with added vegetable oil. The test portion is based on 42 gram available carbohydrates and consumed as a breakfast meal prior to determinations of test variables in the morning.
 Combination Product: Oat Beverage 1
Oat based beverage with added different concentration of extracted oat component.
Experimental: Oat Beverage 2
The test product is an oat based beverage with added vegetable oil. The test portion is based on 42 gram available carbohydrates and consumed as a breakfast meal prior to determinations of test variables in the morning.
 Combination Product: Oat Beverage 2
Oat based beverage with added different concentration of extracted oat component.
Experimental: Oat Beverage 3
The test product is an oat based beverage with added vegetable oil. The test portion is based on 42 gram available carbohydrates and consumed as a breakfast meal prior to determinations of test variables in the morning.
 Combination Product: Oat Beverage 3
Oat based beverage with added different concentration of extracted oat component.
Experimental: Oat Beverage 4
The test product is an oat based beverage. The test portion is based on 42 gram available carbohydrates and consumed as a breakfast meal prior to determinations of test variables in the morning.
 Combination Product: Oat Beverage 4
Oat based beverage with added different concentration of extracted oat component.


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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. IL (interleukin)-6 [ Time Frame: 0 - 5.5 hours ( at fasting and then repeatedly after breakfast and Standardize lunch) ]
    Inflammatory markers in blood

  4. 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

  5. IL- 1beta [ Time Frame: 0 - 5.5 hours ( at fasting and then repeatedly after breakfast and Standardize lunch) ]
    Inflammatory markers in blood


Other Outcome Measures:
  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)

  2. Breath hydrogen concentrations [ Time Frame: 0 - 5.5 hours ( at fasting and then repeatedly after breakfast and Standardize lunch) ]
    Indicator of gut fermentation

  3. Mood (valence and activity) [ 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


Eligibility Criteria
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Ages Eligible for Study:   20 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • healthy adults
  • BMI 18,5 - 25
  • non smokers
  • consuming a non-vegetarian diet that follows the Nordic guidances

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. Further no antibiotics or probiotics should have been consumed within 4 weeks prior to and during the study.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03830736


Locations
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Sweden
Food Technology, engineering and Nutrition, LTH, Lund University
Lund, Sweden, 22100
Sponsors and Collaborators
Lund University
Swedish Foundation for Strategic Research
Investigators
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Study Chair: Anne Nilsson Lund University
More Information
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Responsible Party: Anne Nilsson, Associate professor, Lund University
ClinicalTrials.gov Identifier: NCT03830736    
Other Study ID Numbers: Protokoll 2018/8
First Posted: February 5, 2019    Key Record Dates
Last Update Posted: May 1, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No