Omega-3D: Omega-3 for Diet-Driven Health Disparities

Официальное название

Addressing Diet-Induced Health Disparities With Precision Nutrition and Omega-3 Fatty Acids

Обзор

The goal of this clinical trial is to learn whether omega-3 fatty acid supplementation can reduce inflammation-related biomarkers and improve cardiovascular health in healthy adult volunteers with different genetic backgrounds. The main questions it aims to answer are: Does the response to omega-3 supplementation differ based on genetic variation in the FADS gene cluster (specifically rs174537)? Are changes in fatty acid ratios and inflammation markers greater among individuals of African ancestry compared to those of European ancestry? Researchers will compare omega-3 supplements to a placebo in a randomized, placebo-controlled crossover study to determine whether the Omega-3 supplementation is more effective in certain genetic and ancestry groups. Participants will take omega-3 supplements or a placebo daily for a defined period, then cross over to the other intervention. They will provide blood samples for analysis of fatty acid levels and inflammatory markers, complete questionnaires, and attend scheduled study visits.

Вмешательства

• Пищевая добавка Omega-3 Fatty Acids and Safflower Oil Placebo
  Blinded study supplement; appearance-matched softgels.
• Пищевая добавка Safflower Oil Placebo and Omega-3 Fatty Acids
  Blinded study supplement; appearance-matched softgels.

Первичные конечные точки

• Mean change in circulating arachidonic acid (ARA) between baseline and the end of each 12-week treatment period [Срок оценки: From enrollment to end of phase 2 treatment (week 36)]
• Mean change in the ARA:DGLA ratio between baseline and the end of each 12-week treatment period [Срок оценки: From enrollment to the end of Phase II intervention at 32 weeks.]
• Mean change in the ARA:EPA ratio between baseline and the end of each 12-week treatment period. [Срок оценки: From enrollment to the end of treatment Phase II at 32 weeks.]
• Genotype-dependent differences in the effect of omega-3 supplementation on circulating arachidonic acid (ARA) levels. [Срок оценки: From enrollment to end of phase 2 treatment (week 36)]
• Genotype-dependent differences in the effect of omega-3 supplementation on the ARA:DGLA ratio [Срок оценки: From enrollment to end of Phase II treatment (Week 36)]
• Genotype-dependent differences in the effect of omega-3 supplementation on the ARA:EPA ratio [Срок оценки: From enrollment to end of Phase II treatment (Week 36)]

Критерии участия

Критерии включения

• Age ≥ 18 years
• BMI ≥ 18.5 kg/m2
• Self-identify as non-Hispanic African American or non-Hispanic European American
• Ability and willingness to transport for regular clinic visits.
• Ability and willingness to swallow study capsules.
• Willingness to refrain from intentional weight loss
• Willingness maintain usual physical activity levels and dietary intake throughout the trial.

Критерии исключения

• Age > 65 years
• BMI ≥ 40 kg/m2
• Currently pregnant or breastfeeding.
• Currently receiving treatment for cancer (excluding adjuvant therapies).
• Consumption of DHA/EPA-rich fish 2 or more days a week (defined as >0.5 g DHA or EPA/serving)
• Has a history of atrial fibrillation.
• Has been diagnosed with a significant psychiatric condition that might compromise adherence to study protocols, including eating disorders, schizophrenia, bipolar (manic phase), severe personality disorders, severe major depressive, severe anxiety disorders, and substance use disorders.
• Have an allergy to the study oils.
• Have received other investigational agents within the past 6 months.
• Currently on a weight reducing diet or has lost >5% body weight in the past 6 months.
• Currently using GLP-1
• Currently using prescribed anticoagulants or have a blood clotting problem or disease that causes excessive bleeding or been told by a physician that you have an increased risk of serious bleeding
• Currently using oral steroids
• Perceivably unable or unwilling to use acetaminophen in place of aspirin (including low dose regimen), NSAIDS, or other COX-2 inhibitors.
• Perceivably unable or unwilling to refrain from using anti- inflammatory supplements (including n-3 supplements).
• Perceivably unable or unwilling to refrain from using montelukast-type of allergy medications.
• Run-in failure

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Четверное слепое

Основная цель

Фундаментальное исследование

Центры проведения

США · 2 центра

• Arizona Cancer Center — Tucson
• Georgetown University — Washington D.C.

Идентификаторы

NCT: NCT07078344 · STUDY00005456 · 2R01AT008621-07

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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