Effect of personalized dietary fiber intake on glucose homeostasis through short-chain fatty acid productio

Phase 3

• Conditions: Improving glucose homeostasis

• Registration Number: DRKS00028898
• Lead Sponsor: Gottfried Wilhelm-Leibniz-Universität Hannover Institut für Lebensmittelwissenschaft und Humanernährung

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-05-10
• Study Completion: 2024-01-15
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 23

Inclusion Criteria

Age: 30-65 years
-Willingness to take part on the whole study procedure
-Omnivorous diet
-normoglycemic, healthy

Exclusion Criteria

-Severe chronic diseases
-diagnosed blood coagulation disorders as well as taking anticoagulant drugs e.g. Marcumar (except ASS)
-Known allergy or intolerance to components of the test products
-Abuse of alcohol and drugs
-Participation in another clinical study within the last 30 days
-Pregnancy or lactation
-Planned operation in the next 3 months
-Use of prebiotics, probiotics or antibiotics 3 months prior

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Fasting and postprandial SCFA plasma concentrations (acetate, butyrate and propionate). <br>-Collected via blood sampling at time points t1;0min., t1;30min., t1;90min., t1;120min., t1;180min., t2;0min., t2;30min., t2;90min., t2;120min., t2;180min.<br>t3;0min., t3;30min., t3;90min., t3;120min., t3;180min.

Secondary Outcome Measures

Name	Time	Method
- Fasting and postprandial glucose and insulin concentrations<br>- Satiety and appetite ratings using paper-based visual analogue scales <br>- H2 breath excretion using gas analyses device (Gastrolyzer®)<br>- Fecal gut microbiota composition (16S rRNA gene sequencing)<br>- Gastrointestinal Symptoms Scoring (GSRS questionnaire) <br>- Quality of life questionnaire (SF-36)<br><br>- Anthropometry ( height, length, waist circumference)<br>- Blood pressure <br>- Sociodemographic measures ( age, sex, education, profession) <br>- AST, ALT, ?GT (liver and kidney safety markers)