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

University of Turku

Status: Active, not recruiting

Conditions: High Cholesterol/Hyperlipidemia; High Blood Pressure; Overweight and Obesity

Treatments: Other: Dietary intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT05526092

OGB

Details and patient eligibility

About

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.

Full 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:

1. Compare effect of oat and rice rich diets to blood lipid and glucose status, perceived gut well-being and diet quality.
2. Investigate changes in microbiota, SCFAs, plasma antioxidant status and inflammation markers resulting from consumption of oat or rice rich low gluten diets.
3. Examine the impact of the oat and rice rich gluten free diet on the change in metabolite profiles in blood.
4. 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.
5. 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).

Enrollment: 72 patients

Sex: All

Ages: 30 to 68 years old

Volunteers: No 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)

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

72 participants in 2 patient groups, including a placebo group

Oat-rich and low-gluten diet

Experimental group

Description:

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

Treatment:

Other: Dietary intervention

Rice-rich and low-gluten diet

Placebo Comparator group

Description:

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

Treatment:

Other: Dietary intervention