Quantifiably Determine if the Botanical Formulation, LLP-01, Has a Significant Clinical Effect on Proteomic Inflammatory and Cardiovascular Biomarkers in Healthy, Older Individuals.

NCT06065241 | Completed

• 1 other identifier: SDLLP-01
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief 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 .

Conditions

Aging; Inflammation

Outcome Measures

Primary Outcomes (1)

• 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.

  Change from baseline to 60 days and compared to placebo

Secondary Outcomes (3)

• Grip Strength

  Change from baseline to 60 days and compared to placebo

• Weight/BMI

  Change from baseline to 60 days and compared to placebo

• Well-being

  Change from baseline to 60 days and compared to placebo

Study Arms (2)

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.

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.

Other: Placebo

Interventions

LLP-01 DIETARY_SUPPLEMENT

Participants in the experimental group will take 2 capsules daily containing 1,000mg of the formulation, LLP-01, for 60 days.

Experimental Group

Placebo OTHER

Participants in the placebo group will take 2 capsules daily containing rice flower and small amount of Curcuma Longa for 60 days.

Placebo Group

Eligibility Criteria

• Age: 50 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• LL Prosper Inc.: lead

Study Sites (1)

LL Prosper Inc.

San Diego, California, 92121, United States

Location

MeSH Terms

Conditions

Inflammation

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Adi Ramon, M.Sc

  Chief Compliance Officer

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 2 month, double blind placebo controlled study.

Study Record Dates

• First Submitted: September 26, 2023
• First Posted: October 3, 2023
• Study Start: September 22, 2023
• Primary Completion: March 28, 2024
• Study Completion: March 28, 2024
• Last Updated: January 15, 2026

Record last verified: 2026-01

Locations

US (1)