Aging, Inflammation
Conditions
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 .
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.
Interventions
DIETARY_SUPPLEMENTLLP-01
Participants in the experimental group will take 2 capsules daily containing 1,000mg of the formulation, LLP-01, for 60 days.
OTHERPlacebo
Participants in the placebo group will take 2 capsules daily containing rice flower and small amount of Curcuma Longa for 60 days.
Sponsors
LL Prosper Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Investigator)
Intervention model description
2 month, double blind placebo controlled study.
Eligibility
Sex/Gender
ALL
Age
50 Years to 75 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Plasma Proteomic Changes | 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
| Measure | Time frame | Description |
|---|---|---|
| Grip Strength | Change from baseline to 60 days and compared to placebo | Digital grip strength device to measure absolute grip strength |
| Weight/BMI | Change from baseline to 60 days and compared to placebo | Height and weight to measuring absolute weight and to calculate BMI |
| Well-being | Change from baseline to 60 days and compared to placebo | Questionnaire covering different aspects of well-being |
Countries
United States
Outcome results
None listed