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

NCT06738550 · Status: ENROLLING_BY_INVITATION · Phase: NA · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2024-12-17

No results posted yet for this study

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.

Conditions

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

Sponsors & Collaborators

  • NIN Institute

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-03-01
Primary Completion
2024-07-30
Completion
2025-08-31

Countries

  • Mexico

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06738550 on ClinicalTrials.gov