NCT07063056

Brief Summary

Two dietary supplements are each being compared to a placebo for the ability to help maintain triglycerides in the normal range. The subjects will be adult men and women with moderately high TG values. Serum triglycerides will be measured before and after 6 weeks of taking 1 capsule per day of either Longvida Curcumin, astaxanthin, or a placebo. A few side blood analysis will also be done. These measures are relevant to low level inflammation.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
64

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 3, 2025

Completed
11 days until next milestone

First Posted

Study publicly available on registry

July 14, 2025

Completed
4 days until next milestone

Study Start

First participant enrolled

July 18, 2025

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 15, 2025

Completed
16 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

August 1, 2025

Status Verified

July 1, 2025

Enrollment Period

4 months

First QC Date

July 3, 2025

Last Update Submit

July 29, 2025

Conditions

Keywords

TriglyceridesAntioxidantsInflammation

Outcome Measures

Primary Outcomes (1)

  • Trilgycerides

    Serum triglyceride readings (mg/dL)

    Pre and post 6 week intervention

Secondary Outcomes (2)

  • Other blood lipids

    Before and after the 6 week intervention

  • Inflammation markers

    Measures will be from blood samples taken before and after the 6 week intervention.

Study Arms (4)

Control

PLACEBO COMPARATOR

Subjects will be given 1 capsule per day of a small amount of cellulose

Other: Placebo Control

Regular dose curcumin

EXPERIMENTAL

Subjects will be given 1 capsule per day of a typical amount of Longvida curcumin (80 mg curcumin)

Dietary Supplement: Curcumin (Longvida™)

Low dose curcumin

EXPERIMENTAL

Subjects will be given 1 capsule per day of 40 mg curcumin which is half the typical amount of Longvida curcumin

Dietary Supplement: Half Dose Curcumin (Longvida™)

Astaxanthin

EXPERIMENTAL

Subjects will be given 1 capsule per day of a typical amount of astaxanthin (12 mg curcumin)

Dietary Supplement: Astaxanthin

Interventions

Curcumin (Longvida™)DIETARY_SUPPLEMENT

1 capsule per day at a usual curcumin dose for this particular product (80 mg curcumin)

Regular dose curcumin

1 capsule per day at half the usual curcumin dose for this particular product (40 mg curcumin as the half dose)

Low dose curcumin
AstaxanthinDIETARY_SUPPLEMENT

1 capsule per day at a usual astaxanthin dose (12 mg)

Astaxanthin

Subject will get 1 capsule per day of a small amount of cellulose

Control

Eligibility Criteria

Age21 Years - 59 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Triglyceride reading of 140-250 mg/dL
  • Age 21-59

You may not qualify if:

  • Uncontrolled diabetes
  • Hypothyroidism or other hormonal problems that have not stabilized
  • Any liver diseases being actively treated
  • Cancer
  • Renal dialysis use
  • Rheumatoid arthritis and related issues like lupus
  • Inflammatory bowel disease
  • Smoking
  • Low blood pressure
  • Having more than 5 alcoholic drinks per week
  • Extreme obesity (BMI over 37)
  • Pregnancy or lactation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medinutra LLC

Dublin, Ohio, 43016, United States

RECRUITING

Related Publications (4)

  • DiSilvestro RA, Joseph E, Zhao S, Bomser J. Diverse effects of a low dose supplement of lipidated curcumin in healthy middle aged people. Nutr J. 2012 Sep 26;11:79. doi: 10.1186/1475-2891-11-79.

    PMID: 23013352BACKGROUND
  • Tikhonoff V, Casiglia E, Virdis A, Grassi G, Angeli F, Arca M, Barbagallo CM, Bombelli M, Cappelli F, Cianci R, Cicero AFG, Cirillo M, Cirillo P, Dell'oro R, D'elia L, Desideri G, Ferri C, Galletti F, Gesualdo L, Giannattasio C, Iaccarino G, Mallamaci F, Maloberti A, Masi S, Masulli M, Mazza A, Mengozzi A, Muiesan ML, Nazzaro P, Palatini P, Parati G, Pontremoli R, Quarti-Trevano F, Rattazzi M, Reboldi G, Rivasi G, Russo E, Salvetti M, Temporelli PL, Tocci G, Ungar A, Verdecchia P, Viazzi F, Volpe M, Borghi C. Prognostic Value and Relative Cutoffs of Triglycerides Predicting Cardiovascular Outcome in a Large Regional-Based Italian Database. J Am Heart Assoc. 2024 Feb 6;13(3):e030319. doi: 10.1161/JAHA.123.030319. Epub 2024 Jan 31.

    PMID: 38293920BACKGROUND
  • Kraaijenhof JM, Stroes ESG. Inflammatory Effects of Triglycerides: Relevant or Redundant? JACC Basic Transl Sci. 2023 May 22;8(5):476-478. doi: 10.1016/j.jacbts.2023.04.005. eCollection 2023 May.

    PMID: 37325399BACKGROUND
  • Yoshida H, Yanai H, Ito K, Tomono Y, Koikeda T, Tsukahara H, Tada N. Administration of natural astaxanthin increases serum HDL-cholesterol and adiponectin in subjects with mild hyperlipidemia. Atherosclerosis. 2010 Apr;209(2):520-3. doi: 10.1016/j.atherosclerosis.2009.10.012. Epub 2009 Oct 14.

    PMID: 19892350BACKGROUND

MeSH Terms

Conditions

Inflammation

Interventions

Curcuminastaxanthine

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

DiarylheptanoidsHeptanesAlkanesHydrocarbons, AcyclicHydrocarbonsOrganic ChemicalsCatecholsPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, Cyclic

Study Officials

  • Robert DiSilvestro, Ph.D.

    Medinutra LLC

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Robert DiSilvestro, Ph.D.

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 3, 2025

First Posted

July 14, 2025

Study Start

July 18, 2025

Primary Completion

November 15, 2025

Study Completion

December 1, 2025

Last Updated

August 1, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations