Health Effects of Oats and Oat Bioactive in Human

NCT03830736 | Completed

• 1 other identifier: Protokoll 2018/8
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Postprandial Glucose Regulation

Outcome Measures

Primary Outcomes (1)

• Blood glucose regulation

  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.

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

Secondary Outcomes (5)

• Serum insulin

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

• plasma GLP-1 (glucagon-like peptide-1 )

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

• IL (interleukin)-6

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

• Plasma PYY (peptide tyrosine tyrosine)

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

• IL- 1beta

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

Other Outcomes (3)

• Subjective appetite sensations

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

• Breath hydrogen concentrations

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

• Mood (valence and activity)

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

Study Arms (5)

Control product

PLACEBO COMPARATOR

A glucose solution (glucose and water) based on 42 gram carbohydrates.

Combination Product: Control product

Oat Beverage 1

EXPERIMENTAL

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 Beverage 2

EXPERIMENTAL

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 Beverage 3

EXPERIMENTAL

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 Beverage 4

EXPERIMENTAL

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

Interventions

Oat Beverage 1 COMBINATION_PRODUCT

Oat based beverage with added different concentration of extracted oat component.

Oat Beverage 1

Oat Beverage 2 COMBINATION_PRODUCT

Oat based beverage with added different concentration of extracted oat component.

Oat Beverage 2

Oat Beverage 3 COMBINATION_PRODUCT

Oat based beverage with added different concentration of extracted oat component.

Oat Beverage 3

Oat Beverage 4 COMBINATION_PRODUCT

Oat based beverage with added different concentration of extracted oat component.

Oat Beverage 4

Control product COMBINATION_PRODUCT

Glucose based beverage without added test components is used as control product

Control product

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Lund University: lead
• Swedish Foundation for Strategic Research: collaborator

Study Sites (1)

Food Technology, engineering and Nutrition, LTH, Lund University

Lund, 22100, Sweden

Location

MeSH Terms

Interventions

Control Groups

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Anne Nilsson

  Lund University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Model Details: a randomized blinded cross-over study

Study Record Dates

• First Submitted: January 30, 2019
• First Posted: February 5, 2019
• Study Start: February 18, 2019
• Primary Completion: May 30, 2019
• Study Completion: December 30, 2019
• Last Updated: May 1, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)