The Effect of Algae Oil Supplements on Functional Immune Response and Bioavailability of Lipids in Blood, a Pilot Study

Обзор

In this explorative study we will investigate whether two sustainable oil supplements yield equivalent results to fish oil supplements in terms of postprandial immune response, among elderly adults, after standardization of the quantity of DHA among the oils. Results on the bioavailability of DHA from different oil supplements will help determine whether differences in DHA bioavailability lead to differences in immune function. Additionally, we will investigate postprandial inflammatory markers. The outcomes of this exploratorive study will provide insight into the variation between individuals and potential effect sizes, and will aim to conduct more targeted follow-up studies on the effects of algae oils on immune function.

Вмешательства

• Пищевая добавка Algae oil 1
  DHA Origins 550-Y oil (Fermentalg)
• Пищевая добавка Algae oil 2
  Oleo H-02 (Microalgas)
• Пищевая добавка Fish oil (control)
  Tuna oil

Первичные конечные точки

• Functional immune response [Срок оценки: Baseline (0 hours)]
• Functional immune response [Срок оценки: 4 hours postprandial]
• Functional immune response [Срок оценки: 8 hours postprandial]
• Functional immune response [Срок оценки: 1 week after exposure to the oil]

Вторичные конечные точки (11)

• Plasma DHA levels [Срок оценки: Baseline (0 hours)]
• Plasma DHA levels [Срок оценки: 1 hour postprandial]
• Plasma DHA levels [Срок оценки: 2 hours postprandial]
• Plasma DHA levels [Срок оценки: 3 hours postprandial]
• Plasma DHA levels [Срок оценки: 4 hours postprandial]
• Plasma DHA levels [Срок оценки: 5 hours postprandial]
• Plasma DHA levels [Срок оценки: 6 hours postprandial]
• Plasma DHA levels [Срок оценки: 7 hours postprandial]
• Plasma DHA levels [Срок оценки: 8 hours postprandial]
• Fatty acid levels in plasma and PBMCs [Срок оценки: Baseline (0 hours)]
• Fatty acid levels in plasma and PBMCs [Срок оценки: 1 week after exposure to the oil]

Критерии участия

Критерии включения

• Apparently healthy men and women;
• Age ≥ 50 years
• Body mass index (BMI) ≥18.5 and ≤30 kg/m2;
• Having veins suitable for blood sampling via a catheter (judged by study nurse/ medical doctor);
• Willing to refrain from fish, fish oil, and products with added omega-3 starting from 2 weeks prior to first postprandial test day.
• Willing to keep a stable dietary pattern throughout the study

Критерии исключения

• Having a disease that may interfere with the outcomes of this study, such as a known metabolic, gastrointestinal, inflammatory or chronic disease (such as anaemia, diabetes, hepatitis, cardiovascular disease), as judged by the medical investigator;
• Having a history of medical or surgical events that may significantly affect the study outcome, including: inflammatory bowel disease, hepatitis, pancreatitis, ulcers, gastrointestinal or rectal bleeding; major gastrointestinal tract surgery such as gastrectomy, gastroenterostomy, or bowel resection; known or suspected gastrointestinal disorders, colon or GI tract cancer;
• Use of medication that may interfere with the study outcomes, including gastric acid inhibitors or laxatives, as judged by the medical supervisor.
• Anaemia (Haemoglobin (Hb) values <7.5 mmol/L for women and <8.5 mmol/L for men), as assessed by finger prick blood during screening visit;
• Having swallowing problems with capsules;
• Allergic for fish or shellfish;
• Recent blood donation (<1 month prior to test day 1 of the study) or not willing to stop donation during and 1 month after the study;
• Average alcohol intake >21 (women) or >28 (men) glasses of alcoholic beverages per week;
• Reported weight loss or weight gain of more than 3 kg in the month prior to pre-study screening, or intention to lose weight during the study period;
• Reported to follow or having planned a slimming or medically prescribed diet;
• Use of drugs;
• Current smokers, or stopped smoking in the last 3 months before study start;
• Insufficient proficiency in Dutch to understand information brochure and questionnaires;
• Participation in any clinical trial including blood sampling and/or administration of sub-stances up to 30 days before test day 1 of this study and during the study period;
• Being an employee of the department Food, Health \& Consumer Research Wageningen Food \& Biobased Research or Food Quality and Design of Wageningen University.

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

Другое

Центры проведения

Нидерланды · 1 центр

• Wageningen University & Research — Wageningen

Идентификаторы

NCT: NCT07086573 · 2023-16979

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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