Viewing Study NCT05297032


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Study NCT ID: NCT05297032
Status: TERMINATED
Last Update Posted: 2023-01-10
First Post: 2021-12-09
Is NOT Gene Therapy: False
Has Adverse Events: False

Brief Title: Effects of Quercetin on Metabolic Health
Sponsor: Thorne HealthTech, Inc
Organization:

Study Overview

Official Title: Evaluation of a Computational Model That Predicts the Effects of Quercetin on Metabolic Health Using Biological Age and Other Lipid-related Blood Metrics
Status: TERMINATED
Status Verified Date: 2023-01
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Labs ordering channel is no longer available. Indena (collaborator) opted not to increase funding for an alternative, terminated study.
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: Quercetin is a natural flavonoid compound widely found in vegetables, fruits, and nuts. It has a long history of use as a dietary supplement. This study aims to assess results from a computational model suggesting that quercetin may offer novel benefits to metabolic health. Participants will take quercetin (as Quercetin Phytosome, a proprietary formulation with enhanced absorption properties) for 90 days while keeping lifestyle habits consistent throughout to estimate net effects of quercetin as much as possible. Blood samples will be collected at the beginning and end of the study to assess the effects of quercetin supplementation on metabolic health metrics such as LDL cholesterol, blood sugar, liver, kidney and immune function and calculated metabolic age. In addition, questionnaires will be completed to ensure compliance with study requirements and assess potential quercetin benefits in the participants' quality of life. This work will provide a proof-of-concept from a computational model of nutraceutical compounds and proposes a new application of quercetin in support of healthy human metabolism.
Detailed Description: Following intake and enrollment steps, including providing consent, and approximately one week before other study activities begin, participants will submit an online questionnaire to collect baseline data about lifestyle factors such as diet, exercise, sleep, stress, and general quality of life. During this period they will also receive the study supplement and schedule their first blood draw at a local-to-them Quest Diagnostics facility. Participants will begin taking the study supplement on the day after their first blood draw. Study dosing consists of one capsule of Quercetin Phytosome (Thorne Research, Inc.; 250 mg) taken three times per day with meals for 90 days. Approximately one week after beginning to take study doses, and bi-weekly thereafter, participants will complete an online questionnaire to monitor lifestyle and quality of life factors. The final questionnaire will be completed on the day of or the day after the last study dose is taken. The day after the last study dose, participants will complete a second blood draw at Quest Diagnostics.

Study Oversight

Has Oversight DMC: False
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: