AgingNCT06065241
Quantifiably Determine if the Botanical Formulation, LLP-01, Has a Significant Clinical Effect on Proteomic Inflammatory and Cardiovascular Biomarkers in Healthy, Older Individuals.
A study testing LLP-01 in people with Aging and Inflammation, run by LL Prosper Inc. at 1 site in United States.
Trial summary
This is a prospective, interventional, double-blinded placebo-controlled study of up to 40 participants to evaluate the effect of a botanical formulation on inflammatory and cardiovascular biomarkers . Read more about this study
- Who is it for?
- Ages 50 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Aging, Inflammation
- What is being tested?
- LLP-01
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Sep 2023to 28 Mar 2024
- 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 50 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age: 50-75 years of age
- Any sex / gender
- All ethnicities
- Able to participate in a 2 month trial
- Able to provide informed consent
- Participant must be able to comply with treatment plan and laboratory tests
- Can swallow 00 size capsules
Who cannot join
- Any clinically diagnosed medical disease or disorder that requires prescribed medication(s)
- Currently on any anticoagulant medicines, such as warfarin
- Planned surgical procedure during study period
- Consumption of any supplements within the last 30 days that include the following botanicals/ingredients: green tea extract, Ashwagandha, Fisetin, Curcumin/Turmeric extract, Rosemary extract, Cordyceps, Ginseng
- Allergy or other sensitivity to any of the botanicals in the investigated product
- Currently or have been sick (bacterial or viral infection) in the last 14 days
Show all 11Show fewer
- Alcoholism or drug addiction
- Participation in a clinical research trial within 30 days prior to enrollment in this trial
- Cognitive impairment, illiteracy, inability or unwillingness to give voluntary informed consent
- Unable or unwilling to provide required blood sample for testing and for use in a scientific publication (personal information undisclosed)
- Participants with any condition that may preclude venipuncture/ venous blood draw
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Double Blind Placebo-controlled Trial to Investigate the Effect of a Botanical Formulation, LLP-01, on Proteomic Inflammatory and Cardiovascular Biomarkers.
This is a prospective, interventional, double-blinded placebo-controlled study of up to 40 participants to evaluate the effect of a botanical formulation on inflammatory and cardiovascular biomarkers .
Read the detailed description
The objective of this study is to understand the impact of a multi-botanical formulation on measurements of protein markers, with a focus on inflammation over a 60-day period. The primary objective of this study is to assess the effect of the formulation, LLP-01, on inflammatory and cardiovascular proteomic biomarkers. Adverse events will be self-monitored by participants and will be reported. Changes in weight/calculated BMI and grip strength, as well as changes in well-being through a self-reported questionnaire will also be measured.
- Conditions
- Aging, Inflammation
- Being tested
- LLP-01, Placebo
- Medical subject headings
- Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LLP-01Dietary supplement
Participants in the experimental group will take 2 capsules daily containing 1,000mg of the formulation, LLP-01, for 60 days.
PlaceboOther
Participants in the placebo group will take 2 capsules daily containing rice flower and small amount of Curcuma Longa for 60 days.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | Participants in this arm will receive a herbal capsule formulation, called LLP-01, consisting of 2 capsules taken once daily without food for 60 days. The capsules contain extracts from naturally occurring plant species, including Withania somnifera, Rosmarinus officinalis, Curcuma longa, Cotinus coggygria, Panax ginseng, Cordyceps militaris, Camellia sinensis, Cotinus coggygria, and Piper nigrum. Receives: Dietary Supplement: LLP-01 |
| Placebo Group | Placebo comparator | Participants in this arm will receive Placebo capsules, which are visually identical to the capsules in the Experimental Group. These placebo capsules are filled with rice flour and a minor amount of Curcuma longa powder and should be taken in the same manner as the Experimental Group, with 2 capsules taken once daily without food for 60 days. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma Proteomic Changes
Serum proteomic test to measure significant effects on any of the plasma proteins that will be analyzed. These proteins represent inflammatory, and cardiovascular responses, as well as metabolic functions.
Measured: Change from baseline to 60 days and compared to placebo
Secondary outcomes (3)
Grip Strength
Digital grip strength device to measure absolute grip strength
Measured: Change from baseline to 60 days and compared to placebo
Weight/BMI
Height and weight to measuring absolute weight and to calculate BMI
Measured: Change from baseline to 60 days and compared to placebo
Well-being
Questionnaire covering different aspects of well-being
Measured: Change from baseline to 60 days and compared to placebo
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2023
- Study start22 Sep 2023
- Primary completion28 Mar 2024
- Study completion28 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AgingStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 2 month, double blind placebo controlled study.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- LL Prosper Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Adi Ramon, M.Sc, Principal investigator, Chief Compliance Officer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06065241
- Sponsor's protocol ID
- SDLLP-01
- Status last verified
- Jan 2026
- First submitted
- 26 Sep 2023
- Last updated
- 15 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Double Blind Placebo-controlled Trial to Investigate the Effect of a Botanical Formulation, LLP-01, on Proteomic Inflammatory and Cardiovascular Biomarkers.
- ClinicalTrials.gov ID
- NCT06065241
- Acronym / sponsor ID
- SDLLP-01
- Conditions
- Aging, Inflammation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- LL Prosper Inc.Industry (pharma, biotech, devices)
- Study start
- 22 Sep 2023 (actual)
- Primary completion
- 28 Mar 2024 (actual)
- Study completion
- 28 Mar 2024 (actual)
- First posted
- 3 Oct 2023 (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.
This is a prospective, interventional, double-blinded placebo-controlled study of up to 40 participants to evaluate the effect of a botanical formulation on inflammatory and cardiovascular biomarkers .
Detailed description
The objective of this study is to understand the impact of a multi-botanical formulation on measurements of protein markers, with a focus on inflammation over a 60-day period. The primary objective of this study is to assess the effect of the formulation, LLP-01, on inflammatory and cardiovascular proteomic biomarkers. Adverse events will be self-monitored by participants and will be reported. Changes in weight/calculated BMI and grip strength, as well as changes in well-being through a self-reported questionnaire will also be measured.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- 2 month, double blind placebo controlled study.
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Dietary Supplement: LLP-01Participants in this arm will receive a herbal capsule formulation, called LLP-01, consisting of 2 capsules taken once daily without food for 60 days. The capsules contain extracts from naturally occurring plant species, including Withania somnifera, Rosmarinus officinalis, Curcuma longa, Cotinus coggygria, Panax ginseng, Cordyceps militaris, Camellia sinensis, Cotinus coggygria, and Piper nigrum. |
| Placebo Group | Placebo comparator | Other: PlaceboParticipants in this arm will receive Placebo capsules, which are visually identical to the capsules in the Experimental Group. These placebo capsules are filled with rice flour and a minor amount of Curcuma longa powder and should be taken in the same manner as the Experimental Group, with 2 capsules taken once daily without food for 60 days. |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age: 50-75 years of age
- Any sex / gender
- All ethnicities
- Able to participate in a 2 month trial
- Able to provide informed consent
Key exclusion criteria (11 listed)
- Any clinically diagnosed medical disease or disorder that requires prescribed medication(s)
- Currently on any anticoagulant medicines, such as warfarin
- Planned surgical procedure during study period
- Consumption of any supplements within the last 30 days that include the following botanicals/ingredients: green tea extract, Ashwagandha, Fisetin, Curcumin/Turmeric extract, Rosemary extract, Cordyceps, Ginseng
- Allergy or other sensitivity to any of the botanicals in the investigated product
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 |
|---|---|---|
| LLP-01Participants in the experimental group will take 2 capsules daily containing 1,000mg of the formulation, LLP-01, for 60 days. | Dietary supplement | Experimental Group |
| PlaceboParticipants in the placebo group will take 2 capsules daily containing rice flower and small amount of Curcuma Longa for 60 days. | Other | Placebo Group |
Primary outcome
Plasma Proteomic Changes
Time frame: Change from baseline to 60 days and compared to placebo
Serum proteomic test to measure significant effects on any of the plasma proteins that will be analyzed. These proteins represent inflammatory, and cardiovascular responses, as well as metabolic functions.
3 secondary outcomes
Grip Strength
Time frame: Change from baseline to 60 days and compared to placebo
Weight/BMI
Time frame: Change from baseline to 60 days and compared to placebo
Well-being
Time frame: Change from baseline to 60 days and compared to placebo
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 15 Jan 2026.
- Individual participant dataSharing planned: Undecided
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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.
Adi Ramon, M.Sc principal investigator
Chief Compliance Officer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LLP-01 in people with Aging and Inflammation, run by LL Prosper Inc. 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 7 inclusion and 11 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 15 Jan 2026. 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. Some participants in this study may receive a placebo. 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?
Plasma Proteomic Changes (time frame: Change from baseline to 60 days and compared to placebo). 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 15 Jan 2026.