Healthy DietNCT04596254
Detection of Gut Metabolites in Mother's Milk Following Juice Intake
A study testing Pomegranate Juice in people with Healthy Diet, run by Amazentis SA at 1 site in United States.
Trial summary
The goal of the biological sample collection is to assess the presence of gut metabolites in human breast milk (BM) samples obtained prospectively from healthy lactating mothers and after consumption of fruit juice. Read more about this study
- Who is it for?
- Ages 20 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Diet
- What is being tested?
- Pomegranate Juice
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Oct 2020to 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 20 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 20-40 yrs. female subjects with no lactation problems
- Healthy and term delivery
- Healthy dietary intake (vegetarian or omnivore)
- Agree to donate breast milk (not colostrum)
- First 6 months of lactation
- Subjects agree to consumer 8oz. of pomegranate juice for a week prior to 2nd collection
Who cannot join
- <20 yrs or >40 yrs. of age
- Subjects with lactation problems
- Preterm delivery
- Colostrum samples
- Lactation>6 months
- Subjects fail to drink juice for at least a week
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Human Specimen Collection for Medical Research
The goal of the biological sample collection is to assess the presence of gut metabolites in human breast milk (BM) samples obtained prospectively from healthy lactating mothers and after consumption of fruit juice.
- Conditions
- Healthy Diet
- Being tested
- Pomegranate Juice
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pomegranate JuiceOther
Collection of Mother's milk before and after juice consumption
| Study group | Role | What they receive |
|---|---|---|
| Juice Intake | Other | Not described Receives: Other: Pomegranate Juice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in levels of gut metabolites in breast milk following juice intake
Collection before and after juice intake
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2020
- Study start15 Oct 2020
- Primary completion31 Dec 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 Healthy DietStudies 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amazentis SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Anurag SIngh, MD, PhD, Study director, Amazentis SA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04596254
- Sponsor's protocol ID
- 20.01.AMZ_BIO
- Status last verified
- Jun 2023
- First submitted
- 15 Oct 2020
- Last updated
- 22 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Human Specimen Collection for Medical Research
- ClinicalTrials.gov ID
- NCT04596254
- Acronym / sponsor ID
- 20.01.AMZ_BIO
- Conditions
- Healthy Diet
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Amazentis SAIndustry (pharma, biotech, devices)
- Study start
- 15 Oct 2020 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 22 Oct 2020 (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 the biological sample collection is to assess the presence of gut metabolites in human breast milk (BM) samples obtained prospectively from healthy lactating mothers and after consumption of fruit juice.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Juice Intake | Other | Other: Pomegranate Juice |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 20-40 yrs. female subjects with no lactation problems
- Healthy and term delivery
- Healthy dietary intake (vegetarian or omnivore)
- Agree to donate breast milk (not colostrum)
- First 6 months of lactation
Key exclusion criteria (6 listed)
- <20 yrs or >40 yrs. of age
- Subjects with lactation problems
- Preterm delivery
- Colostrum samples
- Lactation>6 months
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 |
|---|---|---|
| Pomegranate JuiceCollection of Mother's milk before and after juice consumption | Other | Juice Intake |
Primary outcome
Change in levels of gut metabolites in breast milk following juice intake
Time frame: 7 days
Collection before and after juice intake
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 22 Jun 2023.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Anurag SIngh, MD, PhD study director
Amazentis SA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pomegranate Juice in people with Healthy Diet, run by Amazentis SA at 1 site in United States.
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 6 inclusion and 6 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 22 Jun 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 United States. 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?
Change in levels of gut metabolites in breast milk following juice intake (time frame: 7 days). 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 22 Jun 2023.