Plasma SCFAs After Fermentable Cereal Fibres - A Postprandial Study (FIFERM)

Federico II University

Status: Completed

Conditions: Overweight and Obesity

Treatments: Other: Breakfast Control Meal; Other: Breakfast Test Meal

Study type: Interventional

Funder types: Other

Identifiers

NCT05443828

299/20

Details and patient eligibility

About

Circulating SCFAs reflect the net effect of what is produced in the large intestine from dietary fibre fermentation, bioavailability after considerable absorption by the enterocytes and in the liver and the elimination. It is yet unclear to what extent SCFA levels in systemic circulation is of importance for metabolic disease risk and diabetes aetiology. Recent high-impact studies strongly suggest beneficial metabolic effects of butyrate and adverse effects from propionate However, no study has yet investigated to what extent butyrate or propionate producing diets may influence metabolic risk factors for T2D across individuals with different butyrate or propionate producing capacity. The overall aim is to investigate individual's ability to generate high concentrations of butyrate and propionate in plasma after acute intake of different fibre rich foods in an extended postprandial setting. The aim is further to optimize time points for data collection to allow robust assessment of plasma-time concentration profiles of butyrate and propionate to establish a screening approach to identify individuals with high/low butyrate/propionate plasma concentrations. This will be used in later precision nutrition studies where diet will be tailored to high/low SCFA-metabotypes.

Enrollment: 22 patients

Sex: All

Ages: 30 to 75 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Body mass index (BMI) 20-35 kg/m2
• Waist circumference >102 cm (males) or 88 cm (females)
• Haemoglobin, low density lipoprotein (LDL) cholesterol or triglycerides within the normal reference ranges (age and sex specific) according to the laboratory analysing the screening samples.
• Willing to collect faecal samples at home and store them in their household freezer

Exclusion criteria

• Blood donation or participation in a clinical study with blood sampling within 30 days prior to screening visit and throughout the study
• Having been treated with antibiotics within the past 3 months or planning to undergo treatment during the study period.
• Diastolic blood pressure ³ 105 mm Hg at visit 1
• Systolic blood pressure ³ 160 mm at visit 1
• History of stomach or gastrointestinal conditions (Inflammatory bowel disease, Crohn's disease, malabsorption etc.)
• More than 10 hours physical activity per week
• History of heart failure or heart attack within 1 year prior to screening
• Having type I and type 2 diabetes
• Previous gastrointestinal surgery (e.g., gastric bypass, gastric sleeve, bowel resection, colostomy etc.), with the exception of minor surgeries such removal of appendix or gall bladder at least 6 months prior to screening.
• Thyroid disorder not controlled by drug therapy
• History of drug or alcohol abuse
• Stroke or transient ischemic attack (TIA) within 1 year prior to screening
• Consumption of drugs aimed at weight management or drugs affecting body weight to a degree that is considered unsuitable for study participation by responsible physician.
• Pregnant, lactation or planning a pregnancy within the timeframe of the study. Pregnancy must have ended at least 6 months prior to screening, and lactation must have ended at least 1 month prior to screening.
• Food allergies or intolerances preventing consumption of any products included in the study
• Strict vegetarian/vegan (participants must be able to consume the standardized meals used in the study)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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22 participants in 3 patient groups

Extruded puff with vitacel

Active Comparator group

Description:

The participants consumed a portion of extruded puff with added vitacel (cellulose) contained 11 g of fiber, in the context of a breakfast meal

Treatment:

Other: Breakfast Control Meal

AX bread

Experimental group

Description:

Participants consumed a portion of bread enriched with arabynoxylans (AX) contained 11 g of fiber, in the context of a breakfast meal

Treatment:

Other: Breakfast Test Meal

Other: Breakfast Test Meal

Wheat bran puff

Experimental group

Description:

Participants consumed a portion of wheat bran puff contained 11 g of fiber, in the context of a breakfast meal

Treatment:

Other: Breakfast Test Meal

Other: Breakfast Test Meal