HDL Function Dietary Supplement Safety and QOL

NCT04097119 | Unknown

• 1 other identifier: 2019-035-HDL
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

Nutritional supplements are routinely purchased by consumers with suboptimal HDL to support their health, lifestyle and overall quality of life. Many such products receive minimal evaluation prior to marketing. This study aims to evaluate a specific nutritional supplement for its safety, tolerance and acceptability as well as the potential for positive impact on quality of life.

Conditions

HDL; Health, Subjective

Keywords

HDL function; HDL dysfunction; nutritional supplement; quality of life; dietary supplement

Outcome Measures

Primary Outcomes (1)

• Frequency of participant adverse events during the supplementation period

  Tolerability of oral intake of the supplement will primarily be evaluated by determining the frequency of adverse events during the supplementation period

  0 - week 12

Secondary Outcomes (8)

• Medical Outcomes Study Short Form 36 (MOS SF-36) questionnaire

  0 - week 12

• Patient-Reported Outcomes Measurement Information System (PROMIS-43) questionnaire

  0 - week 12

• Rate of HDL function

  0 - week 12

• Profile (amount) of HDL map

  0 - week 12

• Concentration of hsCRP

  0 - week 12

Study Arms (1)

Dietary supplement arm

OTHER

Subjects to receive a specific dietary supplement

Dietary Supplement: Dietary supplementation

Interventions

Dietary supplementation DIETARY_SUPPLEMENT

Subjects receive a specific dietary supplementation designed to support HDL function daily for 12 weeks

Dietary supplement arm

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men: Total HDL of equal to or less than 38 mg / dL in men AND a low HDL-P of less than or equal to 7200 by Spectracell LPP Plus.
• Women: Total HDL equal to or less than 45 mg/dl in women, AND a low HDL-P of less than or equal to 7200 by Spectracell LPP Plus.
• Willingness to maintain current lifestyle (diet and exercise) practices
• Willingness to eat fish no more than twice per week and keep intake stable throughout the study
• Willingness to give written informed consent to participate in the study
• Willingness to follow lifestyle instructions for 24 hours prior to the study visit.
• No known food allergy or intolerance to the ingredients in the study product (fish, shellfish)
• Not currently taking (washout of at least 30 days required) any other supplements that would interfere with the study results
• Not currently taking (washout of at least 30 days required) any other supplements designed to support HDL.

You may not qualify if:

• Use of medications classified as narcotics 30 days prior to Screening and for the duration of the study.
• Use of an investigational drug or participation in an investigational study within 30 days prior to Day 1 and for the duration of the study.
• Current use (at least 30 days wash-out required) of any lipid lowering medication which, in the view of the PI, may interfere with the results.
• Known allergy or hypersensitivity to study product.
• No initiation of a new or change of an existing exercise regimen within 15 days prior to Day 1 and for the duration of the study.
• No initiation of a new or change of an existing food plan 30 days prior to Day 1 and for the duration of the study.
• No current involvement or within 30 days of Day 1 of a significant diet or weight loss program such as Atkin's or other Low-Carb diet programs, very low calorie liquid diet programs (such as Optifast, Medifast and/or HMR) or any diet that has led to a weight loss of 5% of body weight over a period of 10 weeks.
• No serious, unstable illnesses including cardiovascular, hepatic, renal, gastrointestinal, respiratory, endocrine, neurologic, immunologic, or hematologic disease.
• Known infection with Human Immunodeficiency Virus (HIV), Tuberculosis or Hepatitis B or C.
• Subjects with a current diagnosis or personal history of:
• Previous myocardial infarction within 5 years, Unstable angina, Previous stroke or transient ischemic attack (TIA) within 5 years, Uncompensated congestive heart failure, Previous percutaneous transluminal coronary angioplasty (PCTA) or stent within 5 years, Previous coronary artery bypass grafts (CABG) within 5 years
• Type 1 diabetes mellitus
• Any significant liver or kidney disease such as cirrhosis or non-alcoholic fatty liver disease, glomerulonephritis, and/or undergoing dialysis treatment. Cr over 2.5 mg/dL.
• Any malignancy (with the exception of basal or squamous cell carcinoma of the skin if adequately treated and no recurrence for \>5 years).
• Any serious mental illness including depression, manic episodes, post-traumatic disorder, obsessive-compulsive disorder, personality disorders, history of attempted suicide or violence within 12 months prior to Screening and for the duration of the study.

Sponsors & Collaborators

• Metagenics, Inc.: lead
• Hypertension Institute, Nashville: collaborator

Study Sites (1)

Hypertension Institute

Nashville, Tennessee, 37205, United States

Location

MeSH Terms

Interventions

Dietary Supplements

Intervention Hierarchy (Ancestors)

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

Study Officials

• Mark Houston, MD

  Hypertension Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 18, 2019
• First Posted: September 20, 2019
• Study Start: September 18, 2019
• Primary Completion: August 30, 2020
• Study Completion: December 30, 2022
• Last Updated: April 6, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)