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Improving constipation by stimulating fiber intake using personalized dietary advice

Improving constipation by stimulating fiber intake using personalized dietary advice - PAC-study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON49152
Enrollment
25
Registered
2020-05-13
Start date
2020-08-18
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

obstipation

Interventions

personalized advice based on their habitual food pattern (as assessed using a food frequency questionnaire) and preferences. Based on a special algorithm, the PDA provides high fiber alternatives fo

Sponsors

Wageningen Universiteit
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Age *18 years and

Exclusion criteria

Exclusion criteria: - Subjects with a disease that may interfere with the personal dietary advice or outcomes, such as a known autonomic disorder, inflammatory bowel disease, coeliac disease, cancer, dialysis patients, chronic kidney failure, depression or hypothyroidism. - Currently following strict diet and unwilling or unable to change; for example a gluten free diet or a *crash diet* using meal substitutes. - Use of medication that can interfere with the study outcomes, including diuretics, antidepressants, codeine, antibiotics or fiber supplements. Preferably laxative use is excluded, but if recruitment is hurdled by this, we at least exclude specific laxatives like resolor, relistor and constella. These are laxatives who have a significant impact on bowel movements, and are only available on prescription. Osmotic (over the counter available) laxatives will be included if recruitment is difficult. Subjects will then be asked to keep their laxative use stable or reduce, but not to increase usage from their habitual pattern (unless necessary, but then report it to the researchers). Moreover, additional questions regarding laxative usage will be included to estimate the effect of laxatives on stool pattern. - Female subjects: currently pregnant or breastfeeding, or intending to become pregnant during the study, as this can affect stool patterns and wellbeing. - Are simultaneously participating in another study. - Unwilling or unable to fulfil the study criteria.

Design outcomes

Primary

MeasureTime frame
primary outcomes are stool pattern, gastro-intestinal complaints and constipation quality of life and severity.

Secondary

MeasureTime frame
Secondary parameters include dietary fiber intake, physical activity, body weight, psychological questionnaires, and fecal microbiota composition and metabolite levels. Furthermore, the PDA will be evaluated.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)