Evaluate the Effects of a Marine Lipid Oil Concentrate Formulation on Inflammation/Discomfort

NCT04819646 | Completed

• 1 other identifier: CL108
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the study is to assess the efficacy and safety of a Marine Lipid Oil Concentrate formulation on inflammation/discomfort and overall well-being in male and female subjects who are generally healthy

Conditions

Inflammation

Keywords

inflammation; Pain; Discomfort; Soreness

Outcome Measures

Primary Outcomes (4)

• SF-36 (Short Form-36) Health Survey

  Assessment of the mean change in the results from the SF-36 Health Survey from baseline

  60 days

• Medical Symptoms Questionnaire

  Assessment of the mean change in the results from the Medical Symptoms Questionnaire from baseline

  60 days

• Pain Questionnaire

  Assessment of the mean change in the results from the Pain Questionnaire from baseline

  60 days

• Minor body discomfort, pain, or soreness

  Assessment of the mean change in the frequency of minor body discomfort, pain, or soreness per week from baseline

  60 days

Study Arms (1)

Inflammation

EXPERIMENTAL

Marine Lipid Oil concentrate softgel and dietary supplement capsule

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

Interventions

Marine Lipid Oil Concentrate Formulation DIETARY_SUPPLEMENT

Marine Lipid Oil Concentrate softgels

Inflammation

Dietary Supplement DIETARY_SUPPLEMENT

Dietary Supplement capsules

Inflammation

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
• Indicating "very mild," "mild, "or "moderate" for question #7 on the SF-36 Health Survey (How much bodily pain have you had during the past 4 weeks?)
• Have had minor body discomfort, pain, or soreness occurring at least four times per week during the past 4 weeks including symptoms felt when arising in the morning, at the end of a day, during or after physical activity
• Have personal access and able to operate a smartphone, tablet, or computer with enough memory to accommodate additional application(s) and have a reliable internet service
• Able to print out and return documents by scan, email or by mail
• Generally healthy and having no significant difficulty with digestion or absorption of food
• Able to complete an Activity Log and Study Product Log daily
• 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 recommendations to maintain their usual diet and regular activity, as per protocol
• Able to communicate, including reading, in English
• Has not taken any nutritional supplements that may contain any of the components of the study products for a minimum of 14 days before Screening/baseline and for the duration of the study period -

You may not qualify if:

• Not having basic skills needed to operate a smartphone, tablet, or computer
• Having smoked any cigarette, electronic cigarette, cigar, pipe, or used a recreational drug as well as any product containing cannabidiol (CBD) and tetrahydrocannabinol (THC) in the past 30 days
• Having donated blood within 30 days before Screening/baseline
• Having been diagnosed with dysphagia or difficulty swallowing
• Having participated in another study within 30 days prior to 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
• Having taken a lipid lowering medication (including statin medications) on a consistent basis for \> 3 months and have muscle-related pain and/or anticipate a change in the medication during the study period
• Currently taking a medication or dietary supplement specifically for pain or inflammation, including curcumin, and unwilling to washout (i.e., stop taking medication or supplement) 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 which, in the judgment of the Study Investigator/Sub-Investigator, would preclude participation in study
• Currently taking or having taken pain medications or anti-inflammatory medication(s) (e.g., aspirin \> 325 mg, non-steroidal anti-inflammatory drugs \[NSAIDs\], COX-2 (Cyclooxygenase-2) inhibitors, and corticosteroids) within 14 days before Screening/baseline which, in the judgment of the Study Investigator/Sub-Investigator would 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, systemic lupus erythematosus, ankylosing spondylitis, Sjögren's syndrome, polymyalgia rheumatica, inflammatory bowel disease, and psoriatic arthritis)
• Active infection
• Active periodontal disease

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; Pain

Interventions

Dietary Supplements

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; 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: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 24, 2021
• First Posted: March 29, 2021
• Study Start: January 7, 2021
• Primary Completion: September 3, 2021
• Study Completion: November 2, 2021
• Last Updated: January 13, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)