Effectiveness and Safety of Benemix® in Constipation

NCT07427914 | Not Yet Recruiting

• 1 other identifier: Acta Nº 285 CEI-FE (UDEA)
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Constipation - Functional

Keywords

Constipation - Functional; Funtional food; Turmeric; Onion; Magnesium

Outcome Measures

Primary Outcomes (3)

• 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.

Study Arms (1)

Benemix Functional Food Group

EXPERIMENTAL

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

Interventions

Benemix®, a functional food composed of turmeric, onion, magnesium, and lactose-free, skimmed milk powder DIETARY_SUPPLEMENT

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.

Benemix Functional Food Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad de Antioquia: lead

MeSH Terms

Interventions

Magnesium

Intervention Hierarchy (Ancestors)

Metals, Alkaline Earth; Elements; Inorganic Chemicals; Metals, Light; Metals

Central Study Contacts

Javier M Ceballos Rueda, PhD

CONTACT

+573174268448; javier.ceballos@udea.edu.co

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pharmaceutical Chemestry

Study Record Dates

• First Submitted: December 1, 2025
• First Posted: February 23, 2026
• Study Start: July 1, 2026
• Primary Completion: August 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: February 23, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share