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The effect of wheat fiber on increase of fecal bulk

The effect of wheat fiber on increase of fecal bulk - FIBER study: Fiber Intake & fecal Bulk Enhanced Response

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON44243
Enrollment
25
Registered
2017-09-07
Start date
2017-10-23
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

het gaat hier niet zozeer om aandoeningen aan het maag-/darmstelsel, maar de interventie is gericht op het verbeteren van de stoelgang improvement bowel function and defecation

Interventions

Subjects will be randomly assigned to the intervention groups
(*control * *fiber-enriched OR *fiber-enriched * *control). In one of the intervention periods participants receive *control boxes* with products low in wheat fiber and in the other period they wil

Sponsors

J.Rettenmaier & Sohne GmbH & Co.KG
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Male - Apparently healthy - Age range between 18-70 years old - BMI between 20 and 30 kg/m2 - Average fiber intake of 12-18 grams per day - Living in the surrounding area of Wageningen (radius ~20 km)

Exclusion criteria

Exclusion criteria: - Any digestive tract disorder that is expected to interfere with this study (e.g. (partial) gastric resection, (hemi)colectomy, Crohn*s disease, ulcerative colitis, irritable bowel disease, Coeliac disease) - Known food allergy (e.g. lactose, gluten, nuts, egg, etc) - Vegetarians - Use of pro- or prebiotics - Use of medication that can interfere with study outcomes (including laxatives, diuretics, antidepressants, codeine or antibiotics) - Alcohol intake * 40g/day (* 3 glasses of beer/wine per day) - Drug abuse - Current smokers - Participation in other clinical trials in the past month

Design outcomes

Primary

MeasureTime frame
The primairy study parameter is change in fecal bulk between a *low fiber* intervention (with control products) and the wheat fiber enriched product intervention.

Secondary

MeasureTime frame
Secondary parameters are stool consistency, gut-related complaints (e.g. stool frequency, bloating, flatulence), appetite/satiety and food liking.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)