search
Back to results

OAT-GUT-BRAIN: Effects of Oats and Rice on Comprehensive Health of Metabolically Challenged Individuals

Primary Purpose

High Cholesterol/Hyperlipidemia, High Blood Pressure, Overweight and Obesity

Status
Recruiting
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
Dietary intervention
Sponsored by
University of Turku
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for High Cholesterol/Hyperlipidemia

Eligibility Criteria

30 Years - 68 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Commits to follow low-gluten diet for 6 weeks
  • 30 - 68 years of age
  • BMI > 25 kg/m^2
  • High cholesterol AND/OR Hypertension

Exclusion Criteria:

  • Regular medication that can affect the gut
  • Pregnancy or lactation
  • Recent course of antibiotics (less than 3 months prior to the study)

Sites / Locations

  • Institute of Public Health and Clinical Nutrition, University of Eastern FinlandRecruiting
  • Food Chemistry and Food Development, Department of Life Technologies, University of Turku

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Oat-rich and low-gluten diet

Rice-rich and low-gluten diet

Arm Description

Participants will consume oats and oat products and follow low-gluten diet for 6 weeks.

Participants will consume rice and rice products and follow low-gluten diet for 6 weeks.

Outcomes

Primary Outcome Measures

Changes from baseline in plasma short-chain fatty acids
Samples are taken 90 and 180 min after consuming the study meal, and at the fasting state, before and after the 6-week diet intervention to see the change between fasting state and postprandial states.
Changes from baseline in plasma antioxidant capasity
Plasma samples are taken 180 min after consuming the study meal, and at the fasting state, before and after the 6-week diet intervention to see the change between fasting state and postprandial states. The antioxidant status of plasma will be analysed with commercial kits for 2,2'-azino-bis-3-ethylbenzthiazoline-6-sulfonic acid (ABTS) and Oxygen Radical Absorbance Capacity (ORAC) (Merck KGaA, Darmstadt, Germany) to measure antioxidant capacity of plasma.
Changes in blood lipid
Postprandial plasma samples are taken at the fasting state and 15, 30, 45, 60, 90, 120 and 180 min after consuming the study meal before, and after the 6-week diet intervention to see blood lipid development curve in postprandial state.
Changes in glucose status
Postprandial plasma samples are taken at the fasting state and 15, 30, 45, 60, 90, 120 and 180 min after consuming the study meal before, and after the 6-week diet intervention to see blood glucose development curve in postprandial state.
Changes in inflammation markers
The inflammation markers in plasma are measured as a baseline before the study and after 6 week diet intervention. The markers will be analysed with cDNA multiplex immunoassay and qPCR giving semi-quantitative results on a log2 scale (Olink inflammation panel, Olink Proteomics, Uppsala, Sweden). The panel contains at least 92 different proteins that are related to inflammation.
Changes in neuropsychological performance: cognitive load
Established and well-validated computerised neuropsychological tests to measure cognitive load will be conducted both at the beginning and at the end of the intervention in connection with postprandial test. Inquisit software (Millisecond Software, Seattle, Washington, USA; https://www.millisecond.com/download/library/) is used for the cognitive load (Serial Sevens Task) test.
Changes in neuropsychological performance: reaction time and attention
Established and well-validated computerised neuropsychological tests to measure cognitive load will be conducted both at the beginning and at the end of the intervention in connection with postprandial test. Inquisit software (Millisecond Software, Seattle, Washington, USA; https://www.millisecond.com/download/library/) is used for the reaction time and attention (Color Word Stroop test) test.
Changes in neuropsychological performance: response control
Established and well-validated computerised neuropsychological tests to measure cognitive load will be conducted both at the beginning and at the end of the intervention in connection with postprandial test. Inquisit software (Millisecond Software, Seattle, Washington, USA; https://www.millisecond.com/download/library/) is used for the response control (Cued Go/No-Go Task) test.

Secondary Outcome Measures

Changes in gastrointestinal symptoms
Gastrointestinal symptoms (self-reported) during a postprandial study as measured by a questionnaire. The questionnaire is divided into seven types of gastrointestinal discomfort, and also includes a possibility to describe a gastrointestinal discomfort outside these seven given alternatives. The severity of the symptoms is self-reported on a three-step scale (0 as mild or no symptoms, 1 as moderate symptoms, 2 as strong symptoms).
Changes in gut microbiota
Changes in gut microbiota during the dietary intervention as seen in sequencing the fecal samples from the study participants before and after the 6-week dietary intervention.
Changes in excreted bile acids
Changes in excreted bile acids during the dietary intervention analyses from the fecal samples of the study participants before and after the 6-week dietary intervention.

Full Information

First Posted
August 26, 2022
Last Updated
November 8, 2022
Sponsor
University of Turku
Collaborators
University of Eastern Finland
search

1. Study Identification

Unique Protocol Identification Number
NCT05526092
Brief Title
OAT-GUT-BRAIN: Effects of Oats and Rice on Comprehensive Health of Metabolically Challenged Individuals
Official Title
OAT-GUT-BRAIN: Comprehensive Health Effects of Long-term Consumption of Oats in Metabolically Challenged Volunteers - Gut-mediated Metabolomics and Vitality
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 12, 2022 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Turku
Collaborators
University of Eastern Finland

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The overall objective of this research entity is to reveal the holistic health impact of oats in metabolically challenged individuals in a 6-week intervention, compared to that of rice. This is achieved by investigation of the plasma lipids, plasma antioxidant status, fecal microbiota and fecal bile acids. Additionally the effect of the 6-week diet on posptprandial glycemia and postprandial satiety and vitality are investigated.
Detailed Description
Aims in this 6-week randomised, single-blinded clinical trial, including a postprandial study at the 6 week time point, with metabolically challenged volunteers on oat-rich low-gluten diet, are to: Compare effect of oat and rice rich diets to blood lipid and glucose status, perceived gut well-being and diet quality. Investigate changes in microbiota, SCFAs, plasma antioxidant status and inflammation markers resulting from consumption of oat or rice rich low gluten diets. Examine the impact of the oat and rice rich gluten free diet on the change in metabolite profiles in blood. Find out the long-term effects of oat and rice consumption on recovery and vitality by modulating the gut-brain axis and measured with neuropsychological testing and using tryptophan metabolites as markers. Discover how the long-term consumption of oats and rice and their possible alterations in gut microbiota affect subsequent postprandial glycaemia and response of microbiota to the meal (as seen in plasma SCFAs).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
High Cholesterol/Hyperlipidemia, High Blood Pressure, Overweight and Obesity

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Oat-rich and low-gluten diet
Arm Type
Experimental
Arm Description
Participants will consume oats and oat products and follow low-gluten diet for 6 weeks.
Arm Title
Rice-rich and low-gluten diet
Arm Type
Placebo Comparator
Arm Description
Participants will consume rice and rice products and follow low-gluten diet for 6 weeks.
Intervention Type
Other
Intervention Name(s)
Dietary intervention
Intervention Description
Changes in metabolism, microbiota, vitality and comprehensive health after 6 week consumption of oat / rice.
Primary Outcome Measure Information:
Title
Changes from baseline in plasma short-chain fatty acids
Description
Samples are taken 90 and 180 min after consuming the study meal, and at the fasting state, before and after the 6-week diet intervention to see the change between fasting state and postprandial states.
Time Frame
Week 0 and 6
Title
Changes from baseline in plasma antioxidant capasity
Description
Plasma samples are taken 180 min after consuming the study meal, and at the fasting state, before and after the 6-week diet intervention to see the change between fasting state and postprandial states. The antioxidant status of plasma will be analysed with commercial kits for 2,2'-azino-bis-3-ethylbenzthiazoline-6-sulfonic acid (ABTS) and Oxygen Radical Absorbance Capacity (ORAC) (Merck KGaA, Darmstadt, Germany) to measure antioxidant capacity of plasma.
Time Frame
Week 0 and 6
Title
Changes in blood lipid
Description
Postprandial plasma samples are taken at the fasting state and 15, 30, 45, 60, 90, 120 and 180 min after consuming the study meal before, and after the 6-week diet intervention to see blood lipid development curve in postprandial state.
Time Frame
Week 0 and 6
Title
Changes in glucose status
Description
Postprandial plasma samples are taken at the fasting state and 15, 30, 45, 60, 90, 120 and 180 min after consuming the study meal before, and after the 6-week diet intervention to see blood glucose development curve in postprandial state.
Time Frame
Week 0 and 6
Title
Changes in inflammation markers
Description
The inflammation markers in plasma are measured as a baseline before the study and after 6 week diet intervention. The markers will be analysed with cDNA multiplex immunoassay and qPCR giving semi-quantitative results on a log2 scale (Olink inflammation panel, Olink Proteomics, Uppsala, Sweden). The panel contains at least 92 different proteins that are related to inflammation.
Time Frame
Week 0 and 6
Title
Changes in neuropsychological performance: cognitive load
Description
Established and well-validated computerised neuropsychological tests to measure cognitive load will be conducted both at the beginning and at the end of the intervention in connection with postprandial test. Inquisit software (Millisecond Software, Seattle, Washington, USA; https://www.millisecond.com/download/library/) is used for the cognitive load (Serial Sevens Task) test.
Time Frame
Week 0 and 6
Title
Changes in neuropsychological performance: reaction time and attention
Description
Established and well-validated computerised neuropsychological tests to measure cognitive load will be conducted both at the beginning and at the end of the intervention in connection with postprandial test. Inquisit software (Millisecond Software, Seattle, Washington, USA; https://www.millisecond.com/download/library/) is used for the reaction time and attention (Color Word Stroop test) test.
Time Frame
Week 0 and 6
Title
Changes in neuropsychological performance: response control
Description
Established and well-validated computerised neuropsychological tests to measure cognitive load will be conducted both at the beginning and at the end of the intervention in connection with postprandial test. Inquisit software (Millisecond Software, Seattle, Washington, USA; https://www.millisecond.com/download/library/) is used for the response control (Cued Go/No-Go Task) test.
Time Frame
Week 0 and 6
Secondary Outcome Measure Information:
Title
Changes in gastrointestinal symptoms
Description
Gastrointestinal symptoms (self-reported) during a postprandial study as measured by a questionnaire. The questionnaire is divided into seven types of gastrointestinal discomfort, and also includes a possibility to describe a gastrointestinal discomfort outside these seven given alternatives. The severity of the symptoms is self-reported on a three-step scale (0 as mild or no symptoms, 1 as moderate symptoms, 2 as strong symptoms).
Time Frame
Weeks 0 and 6
Title
Changes in gut microbiota
Description
Changes in gut microbiota during the dietary intervention as seen in sequencing the fecal samples from the study participants before and after the 6-week dietary intervention.
Time Frame
Week 0 and 6
Title
Changes in excreted bile acids
Description
Changes in excreted bile acids during the dietary intervention analyses from the fecal samples of the study participants before and after the 6-week dietary intervention.
Time Frame
Week 0 and 6

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
68 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Commits to follow low-gluten diet for 6 weeks 30 - 68 years of age BMI > 25 kg/m^2 High cholesterol AND/OR Hypertension Exclusion Criteria: Regular medication that can affect the gut Pregnancy or lactation Recent course of antibiotics (less than 3 months prior to the study)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kaisa Linderborg, PhD
Phone
0504395535
Ext
+358
Email
kaisa.linderborg@utu.fi
Facility Information:
Facility Name
Institute of Public Health and Clinical Nutrition, University of Eastern Finland
City
Kuopio
ZIP/Postal Code
70211
Country
Finland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marjukka Kolehmainen, PhD
Phone
040 355 3617
Ext
+358
Email
marjukka.kolehmainen@uef.fi
First Name & Middle Initial & Last Name & Degree
Kaisa Linderborg, PhD
First Name & Middle Initial & Last Name & Degree
Marjukka Kolehmainen, PhD
Facility Name
Food Chemistry and Food Development, Department of Life Technologies, University of Turku
City
Turku
ZIP/Postal Code
20500
Country
Finland
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kaisa M Linderborg, PhD
Phone
0504395535
Ext
+358
Email
kaisa.linderborg@utu.fi
First Name & Middle Initial & Last Name & Degree
Kaisa M Linderborg, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

OAT-GUT-BRAIN: Effects of Oats and Rice on Comprehensive Health of Metabolically Challenged Individuals

We'll reach out to this number within 24 hrs