The Effect of Algae Oil Supplements on Functional Immune Response and Bioavailability of Lipids in Blood, a Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Functional immune response
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
Fish oil (control)
Tuna oil
干预措施: Fish oil (control) (Dietary Supplement)
Algae oil supplement 1
Algae oil 1
干预措施: Algae oil 1 (Dietary Supplement)
Algae oil supplement 2
Algae oil 2
干预措施: Algae oil 2 (Dietary Supplement)
结局指标
主要结局
Functional immune response
时间窗: 1 week after exposure to the oil
Measured in isolated PBMCs by calculating the ratio of pro- and anti-inflammatory markers after ex vivo stimulation with LPS and measurement of the cytokine response. The following markers will be measured: pro inflammatory (PGE2, IL-1β, IL-6, IL-8, IFNg, TNFα, CCL2 and CCL5), anti-inflammatory (IL-4 and IL-10).
Functional immune response
时间窗: Baseline (0 hours)
Measured in isolated PBMCs by calculating the ratio of pro- and anti-inflammatory markers after ex vivo stimulation with LPS and measurement of the cytokine response. The following markers will be measured: pro inflammatory (PGE2, IL-1β, IL-6, IL-8, IFNg, TNFα, CCL2 and CCL5), anti-inflammatory (IL-4 and IL-10).
Functional immune response
时间窗: 4 hours postprandial
Measured in isolated PBMCs by calculating the ratio of pro- and anti-inflammatory markers after ex vivo stimulation with LPS and measurement of the cytokine response. The following markers will be measured: pro inflammatory (PGE2, IL-1β, IL-6, IL-8, IFNg, TNFα, CCL2 and CCL5), anti-inflammatory (IL-4 and IL-10).
Functional immune response
时间窗: 8 hours postprandial
Measured in isolated PBMCs by calculating the ratio of pro- and anti-inflammatory markers after ex vivo stimulation with LPS and measurement of the cytokine response. The following markers will be measured: pro inflammatory (PGE2, IL-1β, IL-6, IL-8, IFNg, TNFα, CCL2 and CCL5), anti-inflammatory (IL-4 and IL-10).
次要结局
- Plasma DHA levels(8 hours postprandial)
- Fatty acid levels in plasma and PBMCs(1 week after exposure to the oil)
- Plasma DHA levels(Baseline (0 hours))
- Plasma DHA levels(1 hour postprandial)
- Plasma DHA levels(2 hours postprandial)
- Plasma DHA levels(3 hours postprandial)
- Plasma DHA levels(4 hours postprandial)
- Plasma DHA levels(5 hours postprandial)
- Plasma DHA levels(6 hours postprandial)
- Plasma DHA levels(7 hours postprandial)
- Fatty acid levels in plasma and PBMCs(Baseline (0 hours))
研究者
Maartje van den Belt
Researcher Food, Health & Consumer research
Wageningen University and Research