A Study to Evaluate the Effects of a Marine Lipid Oil Concentrate Formulation on Inflammation

NCT04269876 | Terminated

• 1 other identifier: CL103
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

To assess the efficacy and safety of a Marine Lipid Oil Concentrate formulation on inflammatory biomarkers and overall well-being in male and female subjects who are overweight to mildly obese, but otherwise generally healthy.

Conditions

Inflammation; Inflammatory Response

Outcome Measures

Primary Outcomes (1)

• Assessment of the mean or median change in high sensitivity C-reactive protein (hs-CRP) relative to baseline

  Mean or median change in high sensitivity C-reactive protein (hs-CRP) from baseline to Day 60

  60 days

Secondary Outcomes (4)

• Assessment of the mean or median change in Interleukin-6 (IL-6) relative to baseline

  60 days

• Assessment of the mean or median change in Tumor Necrosis Factor-alpha (TNF-alpha) relative to baseline

  60 days

• Assessment of the mean or median change in Erythrocyte Sedimentation Rate (ESR) relative to baseline

  60 days

• Assessment of the mean or median change in Fibrinogen Activity relative to baseline

  60 days

Study Arms (2)

Marine Lipid Oil concentrate

EXPERIMENTAL

Dietary Supplement: Marine Lipid oil concentrate softgel and dietary supplement capsules

Dietary Supplement: Marine Lipid Oil Concentrate; Dietary Supplement: Dietary Supplement

Placebo

PLACEBO COMPARATOR

Placebo softgels with Placebo capsules

Dietary Supplement: Placebo

Interventions

Marine Lipid Oil Concentrate DIETARY_SUPPLEMENT

Marine Lipid Oil Concentrate softgels

Marine Lipid Oil concentrate

Dietary Supplement DIETARY_SUPPLEMENT

Dietary Supplement capsules

Marine Lipid Oil concentrate

Placebo DIETARY_SUPPLEMENT

Placebo softgels

Placebo

Eligibility Criteria

• Age: 35 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Ambulatory, male or female, 35-75 years of age
• A BMI of 23-34.9
• hs-CRP level of 1-7.5 mg/L
• Generally healthy and having no significant difficulty with digestion or absorption of food
• Has been generally weight stable for the past six months (+/- 6 lbs.)
• Willing and able to give written informed consent
• Clearly understands the procedures and study requirements
• Willing and able to comply with all study procedures, including following the recommendations to maintain their usual diet and regular activity, as per protocol
• Able to communicate, including reading, in English
• Have not taken any nutritional supplements that may contain any of the components of the study product for a minimum of 14 days before Screening/baseline

You may not qualify if:

• Having smoked any cigarette, electronic cigarette, cigar, pipe, or used a recreational drug as well as any product containing cannabidiol (CBD) and tetrahydrocannabinol in the past 30 days.
• Donated blood within 30 days before Screening/baseline
• Inability to provide a venous blood sample
• Participation in another study within 30 days before Screening/baseline
• Being pregnant or planning on becoming pregnant during study participation; or breast feeding
• History of allergy or sensitivity to any component of the study products
• Currently taking a lipid lowering medication or dietary supplement
• Currently taking a medication or dietary supplement specifically for pain or inflammation including curcumin and unwilling to washout (i.e., stop taking) for 14 days before Screening/baseline
• Currently taking or having taken a fish oil, krill oil, omega-3 supplement and omega-3 prescription drugs within the past 3 months before Screening/baseline
• Currently taking or having taken pain medications or anti-inflammatory medication(s) (e.g., aspirin, NSAIDs, Cyclooxygenase-2 (COX-2) inhibitors, and corticosteroids) within 14 days before Screening/baseline or in the judgment of the Study Investigator/Sub-I would not preclude participation in the study
• Having been diagnosed, received medical treatment, or taking medication daily for the following medical condition(s):
• Acute or chronic inflammatory or autoimmune disease (including rheumatoid arthritis, system lupus erythematosus, ankylosing spondylitis, Sjögren's syndrome, polymyalgia rheumatica, inflammatory bowel disease, and psoriatic arthritis)
• Presence of active or recurring clinically significant conditions as follows:
• Diabetes mellitus or other endocrine disease
• Acute infection

Sponsors & Collaborators

• Supplement Formulators, Inc.: lead

Study Sites (1)

Lfie Extension Clinical Reseach, Inc.

Fort Lauderdale, Florida, 33308, United States

Location

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MeSH Terms

Conditions

Inflammation

Interventions

Dietary Supplements

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Andrew Swick, Ph.D

  LIfe Extension

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 12, 2020
• First Posted: February 17, 2020
• Study Start: October 31, 2019
• Primary Completion: September 30, 2021
• Study Completion: September 30, 2021
• Last Updated: January 13, 2023

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)