Effectiveness and Safety of Benemix® in Constipation ((Benemix-UdeA))

Evaluation of the Effectiveness and Safety of Benemix®, a Functional Food, in the Management of Constipation in Adults

The goal of this clinical trial is to find out whether the functional food Benemix® helps treat constipation in adults and whether it is safe to use.

The main questions this study aims to answer are:

Does Benemix® help improve bowel movement frequency and consistency in adults with constipation?

What medical problems, if any, do participants experience while taking Benemix®?

Adults with constipation will take Benemix® every day for 15 days. During the second week, participants will have either an in-person clinic visit or a telemedicine appointment for checkups and tests.

Participants will also receive follow-up phone calls to record:

• daily treatment adherence
• signs and symptoms
• the number of bowel movements each day.

Study Overview

• Status: Not yet recruiting
• Conditions: Constipation - Functional
• Intervention / Treatment: Dietary supplement: Benemix®, a functional food composed of turmeric, onion, magnesium, and lactose-free, skimmed milk powder

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Javier M Ceballos Rueda, PhD; Phone Number: +573174268448; Email: javier.ceballos@udea.edu.co

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Adults (≥18 years old) who use Benemix® for the management of constipation.
• Participants who are using the product for the first time.

Exclusion Criteria:

• Pregnant or breastfeeding women.
• Individuals with a diagnosis of severe gastrointestinal diseases, mental disorders, hemophilia, and/or cancer.
• Individuals who have used laxatives within the last 7 days.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Benemix Functional Food Group; Participants in this arm will receive Benemix®, a functional food composed of turmeric, onion, magnesium, and lactose-free, skimmed milk powder, administered orally once daily for 15 days.

Dietary supplement: Benemix®, a functional food composed of turmeric, onion, magnesium, and lactose-free, skimmed milk powder; Benemix® is a functional food formulation designed to support intestinal health and relieve functional constipation in adults. It contains a combination of turmeric (Curcuma longa), onion (Allium cepa), magnesium, and lactose-free skimmed milk powder. Participants will consume one oral serving of Benemix® once daily for 15 consecutive days. The product is provided as a powdered formulation that must be reconstituted in water or milk prior to consumption. Benemix® differs from other dietary interventions by combining bioactive compounds from turmeric and onion, which have anti-inflammatory and digestive properties, with magnesium, known for its osmotic laxative effect. The lactose-free dairy base is intended to improve tolerability in individuals who are sensitive to lactose. All participants will receive instructions on proper preparation and use of the product. Treatment adherence will be monitored through follow-up phone calls and daily symptom diaries.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in frequency of bowel movements	Number of spontaneous bowel movements per week recorded using a daily patient diary. Unit of Measure: Number of bowel movements per week	From baseline (Day 0) to Day 15.
Change in stool consistency measured by the Bristol Stool Form Scale (BSFS)	Stool consistency will be assessed using the Bristol Stool Form Scale (BSFS), a validated 7-point scale (Type 1 = separate hard lumps; Type 7 = entirely liquid). Types 3-4 represent normal stool consistency. Lower scores indicate harder stools; higher scores indicate looser stools.	From baseline (Day 0) to Day 15.
Incidence of adverse events	Number and type of adverse events recorded during the 15-day intervention period, classified according to severity and relationship to the product. Number of participants with adverse events	Throughout the 15-day intervention period.

Collaborators and Investigators

• Sponsor: Universidad de Antioquia

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: December 1, 2025
• First Submitted That Met QC Criteria: February 16, 2026
• First Posted (Actual): February 23, 2026

Study Record Updates

• Last Update Posted (Actual): February 23, 2026
• Last Update Submitted That Met QC Criteria: February 16, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Onion; Turmeric; Magnesium; Funtional food; Constipation - Functional
• Additional Relevant MeSH Terms: Inorganic Chemicals; Elements; Metals, Light; Metals; Metals, Alkaline Earth; Magnesium
• Other Study ID Numbers: Acta Nº 285 CEI-FE (UDEA)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No