Trials Sponsors Conditions Drugs Pricing

Conditions

Overweight and Obesity Postprandial Hyperglycemia Type2diabetes

Outcome Measures

Primary Outcomes (2)

Plasma amino acids
Plasma free amino acids were measured at 0, 30, 60, 90, 180, and 240 minutes after consuming the study meal.
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.
0-24 hours

Secondary Outcomes (6)

Plasma glucose
0-4 hours
Inflammation marker
0-4 hours
Plasma triglycerides
0-4 hours
Urine para-cresol
24 hours
Plasma insulin
0-4 hours
+1 more secondary outcomes

Study Arms (5)

Meal 1

EXPERIMENTAL

Meal with plant protein and fiber in an intact structure

Dietary Supplement: High fiber and protein meal

Meal 2

EXPERIMENTAL

Meal with plant protein and fiber, where the cell structure is broken

Dietary Supplement: High fiber and protein meal

Meal 3

PLACEBO COMPARATOR

Low protein and low fiber cereal

Dietary Supplement: Control

Interventions

High fiber and protein mealDietary supplement

In the intervention participants are assigned to eat high protein and fiber meal that differ in protein source or structure.

Meal 1Meal 2Meal 4Meal 5

ControlDietary supplement

Eligibility Criteria

Age30 Years - 65 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

years of age
BMI \>25 kg/m2 and \<35 kg/m2

Sponsors & Collaborators

University of Eastern Finland
Otherlead

Study Sites (1)

University of Eastern Finland

Kuopio, 70211, Finland

RECRUITING

Moona PartanenCONTACT+358440101198 moona.partanen@uef.fi

Marjukka KolehmainenCONTACT0403553617 marjukka.kolehmainen@uef.fi

MeSH Terms

Conditions

HyperglycemiaOverweightObesity

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesOvernutritionNutrition DisordersBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

Marjukka Kolehmainen, Professor
University of Eastern Finland
PRINCIPAL INVESTIGATOR

Central Study Contacts

Marjukka Kolehmainen, Professor

CONTACT

0403553617 marjukka.kolehmainen@uef.fi

Moona Partanen, Msc

CONTACT

+358 504759536

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: SPONSOR

Study Record Dates

First Submitted

January 30, 2024

First Posted

February 12, 2024

Study Start

January 18, 2024

Actual (reported)

Primary Completion

June 3, 2024

Estimated (date passed)

A Study of Biochemical Response to Alternative Proteins

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (6)

Study Arms (5)

Meal 1

Meal 2

Meal 3

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

Meal 4

Meal 5

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (6)

Study Arms (5)

Meal 1

Meal 2

Meal 3

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

Meal 4

Meal 5

You may not qualify if:

Data Sharing

Source record

Locations