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

The impact of a dried vegetable fiber on glucose metabolism and microbiota composition - VEZEL study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON46810
Enrollment
60
Registered
2018-03-27
Start date
2018-05-23
Completion date
Unknown
Last updated
2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Glucose metabolism

Interventions

One group receives daily a dose of 30g of WholeFiber (WF fiber) and the other group 16g maltodextrin (placebo) for 21 days. Before that time a 2 week run-in on half the dose wil take place.

Sponsors

Wageningen Universiteit
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

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

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 (

Design outcomes

Primary

MeasureTime frame
Changes in fasting insulin and HOMA-ir (a markers of insulin resistance) are the primary outcomes of the study.

Secondary

MeasureTime frame
Changes in mean glucose and glycemic variability (CGM), body weight, waist circumference, microbiota composition, breath hydrogen and GLP-1/PYY and SCFA are the secondary outcomes.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)