FPPFPP SupplementNCT05191758
Nutritional Regulation of Leukocyte Function
A study testing FPP supplement in people with FPP and Fermented Papaya Preparation, run by Indiana University at 1 site in United States.
Trial summary
The objective of the current study is to determine the dose at which Fermented Papaya Preparation ( FPP) is able to improve inducible respiratory burst outcomes in peripheral blood mononuclear cells (PBMC) and neutrophils of participants. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- FPP, Fermented Papaya Preparation, Supplements
- What is being tested?
- FPP supplement
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Feb 2022to 31 Jul 2023
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Ages 18 and above
- Subjects must be able to follow directions and give informed consent on their own
Who cannot join
- • Individuals who are deemed unable to understand the procedures, risks and benefits of the study, ie. Informed consent will be excluded.
- Females who are pregnant will also be excluded to minimize the risk to such individuals (and fetus).
- Individuals who are therapeutically immuno-compromised will also be excluded to decrease statistical variability and to minimize potential of confounders.
- Candidates for inclusion into the study will not include individuals as defined in 45 CFR 46 Subparts B, C and D, nor from any other population which may be considered vulnerable.
Trial locations and contacts
1 site in 1 country.
United States1 site
Indiana University Health Methodist Hospital
Indianapolis, Indiana, 46228
About this study
The objective of the current study is to determine the dose at which Fermented Papaya Preparation ( FPP) is able to improve inducible respiratory burst outcomes in peripheral blood mononuclear cells (PBMC) and neutrophils of participants. Our investigators have reported that supplementation with standardized fermented papaya preparation (FPP) in mice improves dermal wound healing outcomes. Therefore, based on these observations, the investigators propose to study the dose at which FPP supplementation induces respiratory burst in blood-derived myeloid cells in healthy subjects.
Read the detailed description
Fermented Papaya Preparation (FPP) is a dietary supplement that is available as over-the-counter in the US. FPP possesses antioxidant properties, which provide benefit against age-related complications[]. Chronic wounds in patients with diabetes represent a major public health problem. Previous studies from the investigators have demonstrated that wound-site macrophages from patients with diabetes are compromised in their ability to support wound healing. Several independent observations convergently point toward the hypothesis that treatment with papaya preparations may facilitate wound healing responses. Our laboratory reported the first evidence demonstrating that FPP may improve diabetic wound outcomes by specifically influencing the response of wound-site macrophages and the subsequent angiogenic response. FPP has a long track record of safe human consumption. The objective of the current study is to determine the dose at which FPP is able to improve inducible respiratory burst outcomes in peripheral blood mononuclear cells (PBMC) and neutrophils of participants. Our investigators have reported that supplementation with standardized fermented papaya preparation (FPP) in mice improves dermal wound healing outcomes. Therefore, based on these observations, the investigators propose to study the dose at which FPP supplementation induces respiratory burst in blood-derived myeloid cells in healthy subjects.
- Conditions
- FPP, Fermented Papaya Preparation, Supplements, Diabetic Wound, Healing Wound
- Being tested
- FPP supplement
- Keywords
- fermented papaya, wound healing responses
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FPP supplementDietary supplement
Also called Fermented Papaya Preparation Supplement (FPP), FPP
Participants will take the supplements per randomization
| Study group | Role | What they receive |
|---|---|---|
| control | No intervention | no supplements will be taken |
| 3 grams of supplements | Experimental | subjects will take 3 grams of supplements once per day Receives: Dietary Supplement: FPP supplement |
| 6 grams of supplements | Experimental | subjects will take 3 grams of supplements twice per day Receives: Dietary Supplement: FPP supplement |
| 9 grams of supplements | Experimental | subjects will take 3 grams of supplements three times per day Receives: Dietary Supplement: FPP supplement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reactive Oxygen species (ROS) production of Leucocytes 6 weeks post supplementation
The major objectives of the study is to study the mechanism of action on ROS production by leucocytes of healthy subjects post 6 weeks FPP supplementation measured by flowcytometry
Measured: 6 weeks post supplementation
Blood leukocyte phagocytosis 6 weeks post supplementation
Blood leukocyte phagocytosis 6 weeks post supplementation via cell biology technique
Measured: 6 weeks post supplementation
Secondary outcomes (1)
Leukocyte activation and cytokine production at 6 wks post supplementation
Blood leukocyte activation and cytokine production at 6 weeks post supplementation will be measured via flow cytometry
Measured: 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2022
- Study start15 Feb 2022
- Primary completion8 Jul 2022
- Study completion31 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FPPStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Collaborators
- Osato Research Institute
- Responsible party
- Principal investigator, Dr. Sashwati Roy, Indiana University
- Investigators
- Sashwati Roy, PhD, Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05191758
- Sponsor's protocol ID
- 13229
- Acronym
- FPP Supplement
- Status last verified
- Aug 2023
- First submitted
- 2 Dec 2021
- Last updated
- 21 Aug 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 21 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nutritional Regulation of Leukocyte Function
- ClinicalTrials.gov ID
- NCT05191758
- Acronym / sponsor ID
- FPP Supplement / 13229
- Conditions
- FPP, Fermented Papaya Preparation, Supplements, Diabetic Wound, Healing Wound
- Keywords
- fermented papaya, wound healing responses
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Collaborators
- Osato Research Institute
- Study start
- 15 Feb 2022 (actual)
- Primary completion
- 8 Jul 2022 (actual)
- Study completion
- 31 Jul 2023 (actual)
- First posted
- 13 Jan 2022 (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 objective of the current study is to determine the dose at which Fermented Papaya Preparation ( FPP) is able to improve inducible respiratory burst outcomes in peripheral blood mononuclear cells (PBMC) and neutrophils of participants. Our investigators have reported that supplementation with standardized fermented papaya preparation (FPP) in mice improves dermal wound healing outcomes. Therefore, based on these observations, the investigators propose to study the dose at which FPP supplementation induces respiratory burst in blood-derived myeloid cells in healthy subjects.
Detailed description
Fermented Papaya Preparation (FPP) is a dietary supplement that is available as over-the-counter in the US. FPP possesses antioxidant properties, which provide benefit against age-related complications[]. Chronic wounds in patients with diabetes represent a major public health problem. Previous studies from the investigators have demonstrated that wound-site macrophages from patients with diabetes are compromised in their ability to support wound healing. Several independent observations convergently point toward the hypothesis that treatment with papaya preparations may facilitate wound healing responses. Our laboratory reported the first evidence demonstrating that FPP may improve diabetic wound outcomes by specifically influencing the response of wound-site macrophages and the subsequent angiogenic response. FPP has a long track record of safe human consumption. The objective of the current study is to determine the dose at which FPP is able to improve inducible respiratory burst outcomes in peripheral blood mononuclear cells (PBMC) and neutrophils of participants. Our investigators have reported that supplementation with standardized fermented papaya preparation (FPP) in mice improves dermal wound healing outcomes. Therefore, based on these observations, the investigators propose to study the dose at which FPP supplementation induces respiratory burst in blood-derived myeloid cells in healthy subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| control | No intervention | –no supplements will be taken |
| 3 grams of supplements | Experimental | Dietary Supplement: FPP supplementsubjects will take 3 grams of supplements once per day |
| 6 grams of supplements | Experimental | Dietary Supplement: FPP supplementsubjects will take 3 grams of supplements twice per day |
| 9 grams of supplements | Experimental | Dietary Supplement: FPP supplementsubjects will take 3 grams of supplements three times per day |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Ages 18 and above
- Subjects must be able to follow directions and give informed consent on their own
Key exclusion criteria (4 listed)
- • Individuals who are deemed unable to understand the procedures, risks and benefits of the study, ie. Informed consent will be excluded.
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 |
|---|---|---|
| FPP supplementAlso: Fermented Papaya Preparation Supplement (FPP), FPPParticipants will take the supplements per randomization | Dietary supplement | 3 grams of supplements, 6 grams of supplements, 9 grams of supplements |
Primary outcome
Reactive Oxygen species (ROS) production of Leucocytes 6 weeks post supplementation
Time frame: 6 weeks post supplementation
The major objectives of the study is to study the mechanism of action on ROS production by leucocytes of healthy subjects post 6 weeks FPP supplementation measured by flowcytometry
Blood leukocyte phagocytosis 6 weeks post supplementation
Time frame: 6 weeks post supplementation
Blood leukocyte phagocytosis 6 weeks post supplementation via cell biology technique
1 secondary outcome
Leukocyte activation and cytokine production at 6 wks post supplementation
Time frame: 5 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 21 Aug 2023.
Related trials for FPP
Not yet recruiting
Effect of FPP on Cutaneous Barrier Integrity
Skin Barrier Dysfunction, Healthy Volunteers
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.
Sashwati Roy, PhD principal investigator
Indiana University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FPP supplement in people with FPP and Fermented Papaya Preparation, run by Indiana University 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 2 inclusion and 4 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 21 Aug 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?
Reactive Oxygen species (ROS) production of Leucocytes 6 weeks post supplementation (time frame: 6 weeks post supplementation). 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 21 Aug 2023.