Constipation - Functional(Benemix-UdeA)NCT07427914
Effectiveness and Safety of Benemix® in Constipation
A study testing Benemix®, a functional food composed of turmeric, onion, magnesium, and lactose-free, skimmed milk powder in people with Constipation - Functional, run by Universidad de Antioquia.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Constipation - Functional
- What is being tested?
- Benemix®, a functional food composed of turmeric, onion, magnesium, and lactose-free, skimmed milk powder
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- Jul 2026to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults (≥18 years old) who use Benemix® for the management of constipation.
- Participants who are using the product for the first time.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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:
Read more
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
- Being tested
- Benemix®, a functional food composed of turmeric, onion, magnesium, and lactose-free, skimmed milk powder
- Keywords
- Constipation - Functional, Funtional food, Turmeric, Onion, Magnesium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Benemix®, a functional food composed of turmeric, onion, magnesium, and lactose-free, skimmed milk powderDietary 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Dietary Supplement: Benemix®, a functional food composed of turmeric, onion, magnesium, and lactose-free, skimmed milk powder |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 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
Measured: Throughout the 15-day intervention period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2026
- Study startJul 2026 (estimated)
- Primary completionAug 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Constipation - FunctionalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad de Antioquia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Javier Mauricio Ceballos Rueda, Universidad de Antioquia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07427914
- Sponsor's protocol ID
- Acta Nº 285 CEI-FE (UDEA)
- Acronym
- (Benemix-UdeA)
- Status last verified
- Feb 2026
- First submitted
- 1 Dec 2025
- Last updated
- 23 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effectiveness and Safety of Benemix®, a Functional Food, in the Management of Constipation in Adults
- ClinicalTrials.gov ID
- NCT07427914
- Acronym / sponsor ID
- (Benemix-UdeA) / Acta Nº 285 CEI-FE (UDEA)
- Conditions
- Constipation - Functional
- Keywords
- Constipation - Functional, Funtional food, Turmeric, Onion, Magnesium
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Universidad de AntioquiaUniversity, hospital or other
- Study start
- Jul 2026 (estimated)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 23 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Benemix Functional Food Group | Experimental | Dietary Supplement: Benemix®, a functional food composed of turmeric, onion, magnesium, and lactose-free, skimmed milk powderParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adults (≥18 years old) who use Benemix® for the management of constipation.
- Participants who are using the product for the first time.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Benemix®, a functional food composed of turmeric, onion, magnesium, and lactose-free, skimmed milk powderBenemix® 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. | Dietary supplement | Benemix Functional Food Group |
Primary outcome
Change in frequency of bowel movements
Time frame: From baseline (Day 0) to Day 15.
Number of spontaneous bowel movements per week recorded using a daily patient diary. Unit of Measure: Number of bowel movements per week
Change in stool consistency measured by the Bristol Stool Form Scale (BSFS)
Time frame: From baseline (Day 0) to Day 15.
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.
Incidence of adverse events
Time frame: Throughout the 15-day intervention period.
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2026.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Benemix®, a functional food composed of turmeric, onion, magnesium, and lactose-free, skimmed milk powder in people with Constipation - Functional, run by Universidad de Antioquia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 23 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Javier M Ceballos Rueda, PhD (+573174268448, javier.ceballos@udea.edu.co), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in frequency of bowel movements (time frame: From baseline (Day 0) to Day 15.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2026.