An interventional study of High fiber and protein meal and Control in Postprandial Hyperglycemia, Overweight and Obesity and Type2diabetes, sponsored by University of Eastern Finland. Recruiting at 1 site in Finland. Open to participants aged 30 Years to 65 Years. Per ClinicalTrials.gov, last updated 2024-02-12.
Sponsored by University of Eastern Finland · Not applicable, Interventional, and Prevention
The overall objective of this research is to determine the digestive faith and health impact of protein and fiber rich foods in different food matrices in type 2 diabetes risk population. This is achieved by controlled postprandial intervention where plasma amino acids, lipids, glucose metabolism, bile acids and microbial metabolites are evaluated as well as fecal microbiota and metabolites.
Detailed research aim of this controlled, randomized crossover postprandial clinical study are:
800 studies on the registry are indexed under Hyperglycemia; 115 are open to participants now.
This study's planned enrollment of 24 is below the median of 50 across 620 interventional studies indexed under Hyperglycemia.
Browse Hyperglycemia studies →University of Eastern Finland is the lead sponsor of 54 studies on the registry; 9 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Meal with plant protein and fiber in an intact structure
Dietary Supplement: High fiber and protein meal
Meal with plant protein and fiber, where the cell structure is broken
Dietary Supplement: High fiber and protein meal
Low protein and low fiber cereal
Dietary Supplement: Control
High protein and low carbohydrate bread with animal proteins
Dietary Supplement: High fiber and protein meal
High protein and low carbohydrate bread with plant protein
Dietary Supplement: High fiber and protein meal
In the intervention participants are assigned to eat high protein and fiber meal that differ in protein source or structure.
The control meal is low fiber and low protein meal.
Plasma amino acids
Plasma free amino acids were measured at 0, 30, 60, 90, 180, and 240 minutes after consuming the study meal.
Time frame: 0-4 hours
Gut derived metabolites
Gut derived metabolites are measured with untargeted metabolomics from plasma at 12 hours after consuming the study meal. From fecal sample, the metabolomics are measured at 24 hours after consuming the study meal. Plasma short chain fatty acids are quantified at 12 hours after consuming the study meal.
Time frame: 0-24 hours
Plasma glucose
Plasma glucose is measured at 0, 30, 60, 90, 180, and 240 minutes after consuming the study meal.
Time frame: 0-4 hours
Inflammation marker
Plasma IL-22 is measured at 0, 60, 240 minutes after consuming the study meal.
Time frame: 0-4 hours
Plasma triglycerides
Plasma triglycerides are measured at 0, 30, 60, 90, 180, and 240 minutes after consuming the study meal.
Time frame: 0-4 hours
Urine para-cresol
The amount of para-cresol is measured from urine sample at 24 hours after consuming the study meal.
Time frame: 24 hours
Plasma insulin
Plasma insulin is measured at 0, 30, 60, 90, 180, and 240 minutes after consuming the study meal.
Time frame: 0-4 hours
Plasma free fatty acids
Plasma free fatty acids are measured at 0, 30, 60, 90, 180, and 240 minutes after consuming the study meal.
Time frame: 0-4 hours
Plan to share: No
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University of Eastern Finland