Impact of dried vegetable fibre on sugar metabolism and gut bacteria

Not Applicable

Completed

• Conditions: Prediabetes, increased risk to develop diabetes; Nutritional, Metabolic, Endocrine

• Registration Number: ISRCTN39985847
• Lead Sponsor: Wageningen University (WU) Division of Human Nutrition (Bode 62)

Brief Summary

2022 Results article in https://doi.org/10.1017/gmb.2022.4 (added 01/08/2022)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2018-11-26
• Study Start: 2019-07-22
• Last Update Posted: 22 August 2022

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 55

Inclusion Criteria

1. Age 40-75 years
2. 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

1. Having a history of medical or surgical events that may significantly affect the study outcome: IBS or IBD patients
2. Medical drug use: for diabetes
3. Medical drug use: antibiotic use within 3 months of the study screenings day or chronic use of antacids
4. Mental status that is incompatible with the proper conduct of the study
5. Reported unexplained weight loss or weight gain of > 5 kg in the month prior to pre-study screening
6. Reported slimming or medically prescribed diet
7. Reported vegan or macrobiotic lifestyle
8. Consumption of pre-probiotics or fibre supplements as of 1 month before the screening
9. Sensitive to medical skin adhesives
10. Not willing or afraid to give a blood donation during the study
11. Personnel of Wageningen University, Department of Human Nutrition, their partner and their first-degree relatives
12. Current participation in other research from the Division of Human Nutrition
13. Not having a general practitioner

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Fasting insulin measured in EDTA plasma using ELISA, and HOMA-ir calculated using software from Matthews et al. (1985) (https://www.dtu.ox.ac.uk/homacalculator), at baseline and at end of intervention period, i.e. after 5 weeks (2 weeks run-in and 3 weeks intervention)