The impact of a dried vegetable fiber on glucose metabolism and microbiota compositio

Completed

• Conditions: Glucose metabolism; 10018424

• Registration Number: NL-OMON46810
• Lead Sponsor: Wageningen Universiteit

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 60

Inclusion Criteria

* Male/Female
* Age 40-75 yr
* Fasting blood glucose between 5.6 and 6.9 mmol/L (pre-diabetes according to American Diabetes Association 2016)
* Or fasting blood glucose between 5.0 and 5.6 mmol/L and diabetes risk score (DRS) * 9.

Exclusion Criteria

* Having a history of medical or surgical events that may significantly affect the study outcome (IBS or IBD)
* Having Diabetes
* Medical drug use: for diabetes
* Medical drug use: antibiotic use within 3 months of the study start or chronic use of antacids
* Mental status that is incompatible with the proper conduct of the study
* Reported unexplained weight loss or weight gain of > 5 kg in the month prior to pre-study screening
* Reported slimming or medically prescribed diet
* Reported vegetarian, vegan or macrobiotic life-style
* Consumption of pre-probiotics or fibre supplements
* Sensitive to medical skin adhesives;* Recent blood donation (<1 month prior to Day 01 of the study)
* Not willing or afraid to give up blood donation during the study
* Personnel of Wageningen University, department of Human Nutrition, their partner and their first and second degree relatives
* Current participation in other research from the Division of Human Nutrition
* Not having a general practitioner

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Changes in fasting insulin and HOMA-ir (a markers of insulin resistance) are<br /><br>the primary outcomes of the study. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Changes in mean glucose and glycemic variability (CGM), body weight, waist<br /><br>circumference, microbiota composition, breath hydrogen and GLP-1/PYY and SCFA<br /><br>are the secondary outcomes. </p><br>