Intestinal Bacteria Flora DisturbanceNCT05016999
Allium Extracts on the Intestinal Microbiota in Healthy Resident Volunteers.
A study testing Garlic and onion concentrate in people with Intestinal Bacteria Flora Disturbance, run by DOMCA S.A. at 1 site in Spain.
Trial summary
To evaluate the effect of daily consumption of a combination of garlic and onion extracts on the intestinal microbiota and the production of short chain fatty acids in elderly healthy volunteers living in a residence. Likewise, any incident related to health that occurred during that period will be noted. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Intestinal Bacteria Flora Disturbance
- What is being tested?
- Garlic and onion concentrate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 1 siteSpain
- Study dates
- 1 Aug 2021to 31 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Men and women aged 65 years or older who participated in study C002.
- 2. Living in the Claret Residence for the Elderly in Granada during the study.
- Accept being vaccinated for the flu.
- Freely accepted to participate in the study and sign the informed consent document.
- Have the consent of the family.
Who cannot join
- Having any disease that affects the development and results of the study.
- Be unable to understand the study and sign voluntarily and freely the informed consent.
- Have a low expectation of compliance with the study protocol.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Effect of the Consumption of a Combination of Allium Extracts on the Intestinal Microbiota in Healthy Elderly Resident Volunteers. Preliminary Study.
To evaluate the effect of daily consumption of a combination of garlic and onion extracts on the intestinal microbiota and the production of short chain fatty acids in elderly healthy volunteers living in a residence.
Likewise, any incident related to health that occurred during that period will be noted.
Read the detailed description
This study is a continuation of another (C002, registration number NCT04647071).
The volunteers from study C002 were invited to participate in this new study and, by the end of C002, all gave 2 stool samples.
After 4 weeks of washout, the control group volunteers in C002 will begin consuming 1 capsule per day of garlic and onion extract after lunch. The intervention group volunteers in C002 will not consume anything.
During 36 weeks any incident related to the health of the volunteers will be noted. Likewise, during this time, the volunteers will maintain their lifestyle and eating habits.
At 36 weeks, 2 stool samples will be taken from all volunteers.
- Conditions
- Intestinal Bacteria Flora Disturbance
- Being tested
- Garlic and onion concentrate
- Keywords
- Garlic, Onion, Microbiota
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Garlic and onion concentrateDietary supplement
Also called AlioCare
Garlic extract concentrate (equivalent to 2 garlic cloves) and onion extract concentrate (equivalent to 1 onion)
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Volunteers in this group will not take any products. |
| Intervention | Experimental | Garlic concentrated extract plus onion concentrated extract plus microcrystalline cellulose (9892- Capsules®) up to 400 mg. Receives: Dietary Supplement: Garlic and onion concentrate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in bacterial species in feces.
The bacterial populations present in the stool samples taken at the beginning and at the end of the study will be studied.
Measured: 36 weeks.
Short chain fatty acids in stool.
Short chain fatty acids present in stool samples taken at the beginning and end of the study will be studied.
Measured: 36 weeks.
Secondary outcomes (2)
Events during 36 weeks.
Any health-related events that occurred during the study and their duration will be noted.
Measured: 36 weeks
Medication during 36 weeks.
The consumption of drugs during the study and its duration will be recorded.
Measured: 36 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2021
- Study start1 Aug 2021
- Primary completion15 Jun 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intestinal Bacteria Flora DisturbanceStudies 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
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- DOMCA S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Carlos Gracián Alcaide, MD, Principal investigator, Claret Residence for the Elderly (Granada, Spain).
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05016999
- Sponsor's protocol ID
- C004
- Status last verified
- Aug 2021
- First submitted
- 17 Aug 2021
- Last updated
- 23 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effect of the Consumption of a Combination of Allium Extracts on the Intestinal Microbiota in Healthy Elderly Resident Volunteers. Preliminary Study.
- ClinicalTrials.gov ID
- NCT05016999
- Acronym / sponsor ID
- C004
- Conditions
- Intestinal Bacteria Flora Disturbance
- Keywords
- Garlic, Onion, Microbiota
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- DOMCA S.A.Industry (pharma, biotech, devices)
- Study start
- 1 Aug 2021 (actual)
- Primary completion
- 15 Jun 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 23 Aug 2021 (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.
To evaluate the effect of daily consumption of a combination of garlic and onion extracts on the intestinal microbiota and the production of short chain fatty acids in elderly healthy volunteers living in a residence.
Likewise, any incident related to health that occurred during that period will be noted.
Detailed description
This study is a continuation of another (C002, registration number NCT04647071).
The volunteers from study C002 were invited to participate in this new study and, by the end of C002, all gave 2 stool samples.
After 4 weeks of washout, the control group volunteers in C002 will begin consuming 1 capsule per day of garlic and onion extract after lunch. The intervention group volunteers in C002 will not consume anything.
During 36 weeks any incident related to the health of the volunteers will be noted. Likewise, during this time, the volunteers will maintain their lifestyle and eating habits.
At 36 weeks, 2 stool samples will be taken from all volunteers.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Volunteers in this group will not take any products. |
| Intervention | Experimental | Dietary Supplement: Garlic and onion concentrateGarlic concentrated extract plus onion concentrated extract plus microcrystalline cellulose (9892- Capsules®) up to 400 mg. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- Men and women aged 65 years or older who participated in study C002.
- 2. Living in the Claret Residence for the Elderly in Granada during the study.
- Accept being vaccinated for the flu.
- Freely accepted to participate in the study and sign the informed consent document.
- Have the consent of the family.
Key exclusion criteria (3 listed)
- Having any disease that affects the development and results of the study.
- Be unable to understand the study and sign voluntarily and freely the informed consent.
- Have a low expectation of compliance with the study protocol.
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 |
|---|---|---|
| Garlic and onion concentrateAlso: AlioCareGarlic extract concentrate (equivalent to 2 garlic cloves) and onion extract concentrate (equivalent to 1 onion) | Dietary supplement | Intervention |
Primary outcome
Changes in bacterial species in feces.
Time frame: 36 weeks.
The bacterial populations present in the stool samples taken at the beginning and at the end of the study will be studied.
Short chain fatty acids in stool.
Time frame: 36 weeks.
Short chain fatty acids present in stool samples taken at the beginning and end of the study will be studied.
2 secondary outcomes
Events during 36 weeks.
Time frame: 36 weeks
Medication during 36 weeks.
Time frame: 36 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2023.
Related trials for Intestinal Bacteria Flora Disturbance
Active, not recruitingPhase 2
Resistant Maltodextrin for Gut Microbiome in Parkinson's Disease: Safety and Tolerability Study
Parkinson Disease, Intestinal Bacteria Flora Disturbance
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. This study is not recruiting at the moment.
Carlos Gracián Alcaide, MD principal investigator
Claret Residence for the Elderly (Granada, Spain).
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Garlic and onion concentrate in people with Intestinal Bacteria Flora Disturbance, run by DOMCA S.A. at 1 site in Spain.
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 5 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: finished, as of the sponsor's last update on 23 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in bacterial species in feces. (time frame: 36 weeks.). The study lists 2 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 2023.