Concentration of n-3 PUFA Monohydroxylated Derivatives in Adults With Obesity After Supplementation With "SPM Active®".
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 33
- 试验地点
- 1
- 主要终点
- Change in Plasma Levels of Monohydroxylated n-3 PUFA Derivatives (14-HDHA, 17-HDHA, 18-HEPE)
研究概览
简要总结
The goal of this clinical trial is to learn if daily supplementation with SPM Active® can increase omega 3 polyunsaturated fatty acid derivatives and improve well-being in adults with obesity. The main questions it aims to answer are:
Does 2 g/day of SPM Active® for 12 weeks increase plasma levels of 14-hydroxydocosahexaenoic (HDHA), 17-HDHA, and 18-hydroxy eicosapentaenoic acid (HEPE)?
Does 2 g/day of SPM Active® for 12 weeks improve self-reported burnout, life satisfaction, and sleep quality?
Participants will:
Take two SPM Active® soft-gel capsules daily for 12 weeks (±2-4 days).
Provide 12-hour fasting blood samples before and after the intervention.
Complete validated surveys on burnout, life satisfaction, and sleep quality at baseline and study end.
详细描述
Purpose: This study aims to explore the effects of 'SPM Active®,' an omega-3 polyunsaturated fatty acid (n-3 PUFA) dietary supplement, on male adults with obesity. The supplement specifically targets the increase of monohydroxylated derivatives of n-3 PUFAs, which play a crucial role in reducing chronic, low-grade inflammation. The primary objective of the study is to determine whether administering SPM Active® at 2g/day for a longer duration (3 months) leads to higher levels of the monohydroxylated derivatives (14-HDHA, 17-HDHA, and 18-HEPE) in adults with obesity (BMI between 30 and 40 kg/m^2, n=33). The secondary objective is to evaluate whether administration of SPM Active® improves the following outcomes: a) burnout, b) life satisfaction, and c) sleep quality. These outcomes will be assessed using validated surveys administered before and after the intervention.
Participants: The study will include 33 healthy male and female participants of any ethnicity, aged 45-60 years, with a BMI of 30-40 kg/m^2.
Procedures: The intervention involves the administration of the dietary supplement 'SPM Active®' provided by Metagenics. All participants will take 2 soft gel capsules per day for 12 weeks, with a window of +/- 2-4 days. A 12-hour fasting blood sample will be collected from each participant before and after the intervention by a licensed phlebotomist at the UNC Nutrition Research Institute (NRI) at Kannapolis, NC. Additionally, participants will complete surveys at the start and end of the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 45 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •adults, ages 45-60 years
- •Body mass index (BMI) between 30 and 40 kg/m^2
- •Any race or ethnicity
排除标准
- •Age < 45 years or > 60 years
- •pregnant or breastfeeding women
- •BMI < 30 kg/m^2 or > 40 kg/m^2
- •Diagnosed type 1 or type 2 diabetes
- •Active autoimmune disease, liver disease, coagulopathy, or hypothyroidism
- •Known allergy to fish or shellfish
- •Current use of any of the following medications: asthma controller therapies, anticoagulants, estrogen or testosterone, daily aspirin or NSAIDs.
- •Inability to give informed consent
- •Receiving immunomodulatory or immunosuppressant therapy
- •Known active malignancy or undergoing treatment for malignancy
- •Use of n-3 PUFA supplements or high consumption of fatty fish (> 2 servings/week) within 3 months prior to enrollment.
研究组 & 干预措施
SPM Active® Supplementation
All participants will take two SPM Active® soft-gel capsules daily (total 2 g/day) for 12 weeks (± 2-4 days). Fasting blood samples will be drawn at baseline and at end-of-treatment to quantify 14-HDHA, 17-HDHA, and 18-HEPE levels. Validated surveys assessing burnout, life satisfaction, and sleep quality will be administered before and after the supplementation period.
干预措施: SPM Active® (Dietary Supplement)
结局指标
主要结局
Change in Plasma Levels of Monohydroxylated n-3 PUFA Derivatives (14-HDHA, 17-HDHA, 18-HEPE)
时间窗: Baseline (Day 0) and End of Treatment (Week 12 ± 2-4 days)
Mean change from baseline in fasting plasma concentrations of 14-HDHA, 17-HDHA, and 18-HEPE, as quantified by liquid chromatography-mass spectrometry.
次要结局
- Change in Burnout Score(Baseline (Day 0) and End of Treatment (Week 12 ± 2-4 days))
- Change in Life Satisfaction Score(Baseline (Day 0) and End of Treatment (Week 12 ± 2-4 days))
- Change in Sleep Quality Score(Baseline (Day 0) and End of Treatment (Week 12 ± 2-4 days))