Health Effects of Oats and Oat Bioactive in Human

Sponsor
Lund University (Other)
Overall Status
Completed
CT.gov ID
NCT03830736
Collaborator
Swedish Foundation for Strategic Research (Other)
24
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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: Oat Beverage 1
  • Combination Product: Oat Beverage 2
  • Combination Product: Oat Beverage 3
  • Combination Product: Oat Beverage 4
  • Combination Product: Control product
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 :
24 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Intervention Model Description:
a randomized blinded cross-over studya 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 :
Feb 18, 2019
Actual Primary Completion Date :
May 30, 2019
Actual Study Completion Date :
Dec 30, 2019

Arms and Interventions

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

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. IL (interleukin)-6 [0 - 5.5 hours ( at fasting and then repeatedly after breakfast and Standardize lunch)]

    Inflammatory markers in blood

  4. 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

  5. IL- 1beta [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 [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 [0 - 5.5 hours ( at fasting and then repeatedly after breakfast and Standardize lunch)]

    Indicator of gut fermentation

  3. Mood (valence and activity) [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

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 - 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

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

  • Study Chair: Anne Nilsson, Lund University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Anne Nilsson, Associate professor, Lund University
ClinicalTrials.gov Identifier:
NCT03830736
Other Study ID Numbers:
  • Protokoll 2018/8
First Posted:
Feb 5, 2019
Last Update Posted:
May 1, 2020
Last Verified:
Apr 1, 2020
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 May 1, 2020