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OpenTrials
Completed

NCT Number: NCT06065241

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

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 .

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Key information

Age range

50 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

LL Prosper Inc.

San Diego, California, 92121, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

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.

Placebo

Other

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. Grip Strength

    Time frame: Change from baseline to 60 days and compared to placebo

    Digital grip strength device to measure absolute grip strength

  2. Weight/BMI

    Time frame: Change from baseline to 60 days and compared to placebo

    Height and weight to measuring absolute weight and to calculate BMI

  3. Well-being

    Time frame: Change from baseline to 60 days and compared to placebo

    Questionnaire covering different aspects of well-being

Sponsors and collaborators

Lead sponsor

LL Prosper Inc.

Industry

Registry information

Official study title

Randomized Double Blind Placebo-controlled Trial to Investigate the Effect of a Botanical Formulation, LLP-01, on Proteomic Inflammatory and Cardiovascular Biomarkers.

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Oct 3, 2023
Registry last updated
Jan 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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