Health Effects of Oats and Oat Bioactive in Human

• ClinicalTrials.gov Identifier: NCT03830736
• Recruitment Status: Completed
• First Posted: February 5, 2019
• Last Update Posted: May 1, 2020
• Sponsor: Lund University
• Collaborator: Swedish Foundation for Strategic Research
• Information provided by (Responsible Party): Anne Nilsson, Lund University

Tracking Information

• First Submitted Date: January 30, 2019
• First Posted Date: February 5, 2019
• Last Update Posted Date: May 1, 2020
• Actual Study Start Date: February 18, 2019
• Actual Primary Completion Date: May 30, 2019 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: February 4, 2019)

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.

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: February 4, 2019)

• 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.
• 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
• IL (interleukin)-6 [ Time Frame: 0 - 5.5 hours ( at fasting and then repeatedly after breakfast and Standardize lunch) ]
  Inflammatory markers in blood
• 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
• IL- 1beta [ Time Frame: 0 - 5.5 hours ( at fasting and then repeatedly after breakfast and Standardize lunch) ]
  Inflammatory markers in blood

• Original Secondary Outcome Measures: Same as current

Current Other Pre-specified Outcome Measures (submitted: February 4, 2019)

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

• Original Other Pre-specified Outcome Measures: Same as current

Descriptive Information

• Brief Title: Health Effects of Oats and Oat Bioactive in Human
• Official Title: Effects of Oat and Oat Components on Cardiometabolic- and Cognitive Test Variables
• 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.
• 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 Type: Interventional
• Study Phase: Not Applicable

Study Design

Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description:

a randomized blinded cross-over study

Masking: Single (Participant)
Primary Purpose: Prevention

• Condition: Postprandial Glucose Regulation

Intervention

• Combination Product: Oat Beverage 1
  Oat based beverage with added different concentration of extracted oat component.
• Combination Product: Oat Beverage 2
  Oat based beverage with added different concentration of extracted oat component.
• Combination Product: Oat Beverage 3
  Oat based beverage with added different concentration of extracted oat component.
• Combination Product: Oat Beverage 4
  Oat based beverage with added different concentration of extracted oat component.
• Combination Product: Control product
  Glucose based beverage without added test components is used as control product

Study Arms

• Placebo Comparator: Control product
  A glucose solution (glucose and water) based on 42 gram carbohydrates.
  Intervention: Combination Product: 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.
  Intervention: Combination Product: Oat Beverage 1
• 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.
  Intervention: Combination Product: Oat Beverage 2
• 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.
  Intervention: Combination Product: Oat Beverage 3
• 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.
  Intervention: Combination Product: Oat Beverage 4

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: February 4, 2019): 24
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: December 30, 2019
• Actual Primary Completion Date: May 30, 2019 (Final data collection date for primary outcome measure)

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 20 Years to 40 Years (Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Sweden

Administrative Information

• NCT Number: NCT03830736
• Other Study ID Numbers: Protokoll 2018/8
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

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

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Anne Nilsson, Lund University
• Original Responsible Party: Same as current
• Current Study Sponsor: Lund University
• Original Study Sponsor: Same as current
• Collaborators: Swedish Foundation for Strategic Research

Investigators

• Study Chair: Anne Nilsson; Lund University

• PRS Account: Lund University
• Verification Date: April 2020