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Efficacy of a Dietary Intervention for the Treatment of Constipation in Institutionalized Older Adults. Medellín, 2023-2024.

NCT05923723 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 56

Last updated 2024-08-21

No results posted yet for this study

Summary

The objective of this clinical trial is to determine if a dietary intervention for the treatment of chronic idiopathic constipation in older adults in the city of Medellin is effective (works well), focusing on the population in geriatric care centers and institutions. The goal is to obtain scientific evidence that allows determining the efficacy of this intervention for the non-pharmacological treatment of constipation in the elderly. The main question to be answered is:

"Is a dietary product designed with psyllium, chia, and flaxseed a reliable and effective treatment for managing constipation in older adults?"

The intervention and follow-up period for the study has been set at 6 weeks (45 days). During this time, participants will receive orally, once a day (every 24 hours), 1 tablespoon (20g) of the product - FIBNUTRITION - (a natural food product rich in fiber, with its main components being flaxseed, chia, and psyllium), mixed in an 8oz glass (approximately 250ml) of room temperature water using a blender (following the manufacturer's instructions for use). The product will be provided to each patient in the morning before breakfast.

The proposed research corresponds to an intervention study, specifically a randomized, controlled, double-blind, multicenter clinical trial. The researchers will compare an intervention group (dietary intervention) with a control group (placebo: a similar product that does not contain fiber or components that can alter the intestinal tract) to observe if there is a difference of at least 40% in the prevalence of satisfactory relief of constipation symptoms (desired primary effect criterion) between the two groups.

Conditions

  • Constipation Chronic Idiopathic

Interventions

OTHER

FIBNUTRITION

The dietary product selected for the study is commercially known as FIBNUTRITION, marketed in Colombia by Bio-Nutrition S.A.S with sanitary registration number NSA-001942-2016. Ingredients of the product: Flaxseed, Chia seeds, Psyllium, Polydextrose, Oat flour, Apple, Orange, Artificial flavor (Orange), Pineapple, Nopal, Xanthan gum (thickener), Silicon dioxide, Stevia (Natural sweetener), Lactobacillus Acidophilus Bifidus Casei (Prebiotics), Sodium Benzoate (Preservative), and Turmeric (Natural colorant).

OTHER

Placebo

The placebo is a dietary product composed of maltodextrin, cornstarch, orange flavoring, and stevia.

Sponsors & Collaborators

  • CES University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
60 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-03-15
Primary Completion
2024-06-18
Completion
2024-06-25

Countries

  • Colombia

Study Locations

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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 NCT05923723 on ClinicalTrials.gov