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

LL Prosper

Status: Completed

Conditions: Aging; Inflammation

Treatments: Other: Placebo; Dietary Supplement: LLP-01

Study type: Interventional

Funder types: Industry

Identifiers

NCT06065241

SDLLP-01

Details and patient eligibility

About

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 .

Full 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.

Enrollment: 32 patients

Sex: All

Ages: 50 to 75 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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32 participants in 2 patient groups, including a placebo group

Experimental Group

Experimental group

Description:

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.

Treatment:

Dietary Supplement: LLP-01

Placebo Group

Placebo Comparator group

Description:

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.

Treatment:

Other: Placebo