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ENROLLING BY INVITATION
NCT06738550
NA

Effect of Agave Inulin on Constipation and Quality of Life in Peritoneal Dialysis Patients.

Sponsor: NIN Institute

View on ClinicalTrials.gov

Summary

This is a randomized controlled clinical study realized in the nephrology service of the Centro Medico ISSEMyM hospital in Metepec, State of Mexico, including new patients on Peritoneal Dialysis (PD) over 18 years of age with constipation criteria, the Bristol scale and Rome IV Criteria were used, with a 6-month follow-up with a personalized diet plan, intervention group supplementation with agave Tequiliana blue variety inulin with an initial dose of 9 grams per day, the control gruop recived lactulosa. Data were obtained from the clinical history comorbidities present in the patients, anthropometric data such as weight, % of fat, % of body water, Fat Free Mass (FFM) obtained using a TANITA scale model BC-533; skin folds were obtained using a slim Guide plicometer, dietary data such as energy intake (kcal), protein intake, fluid intake, were estimated using a 24 hr reminder. A questionnaire was also applied to measure gastrointestinal symptoms and their evolution with the intervention, in addition to the KDQOL-SF to evaluate the quality of life of the patients.

Official title: Effect of Agave Inulin on Constipation and Quality of Life in Peritoneal Dialysis Patients

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

45

Start Date

2023-03-01

Completion Date

2025-08-31

Last Updated

2024-12-17

Healthy Volunteers

Yes

Interventions

DIETARY_SUPPLEMENT

inulin

In the patients of the experimental group, the nutritional intervention is personalized, agave inulin supplementation is provided 9 gr per day, A 6-month follow-up is provided

DRUG

Lactulose oral solution

In the patients of the experimental group, the nutritional intervention is personalized, A 6-month follow-up is provided and taken syrup lactulose 10 ml every 8 hours

Locations (1)

Centro Medico ISSEMyM, Toluca

Metepec, State of Mexico, Mexico