Evaluation of the Anti-inflammatory Effects of a Snack Enriched With Camelina Sativa Oil in Free-living Older Adults: a Randomized, Double-blind, Placebo-controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 135
- 试验地点
- 2
- 主要终点
- Inflammatory status evaluation.
研究概览
简要总结
The present study aims at evaluating the anti-inflammatory effects of a novel food in older adult volunteers. Briefly, this randomized, double-blind and placebo-controlled study is performed on 91 apparently healthy older adults (age≥65 years) before and after 12 weeks' consumption of a snack enriched with camelina Sativa oil. Subjects were randomized into two groups (active group vs placebo group).
详细描述
Ninety-one volunteers (26M/65F) are enrolled according to the following inclusion criteria i) free-living older adults ≥ 65 years; ii) apparently healthy subjects; iii) subjects who do not take vitamin supplements/integration and/or omega 3 polyunsaturated fatty acids; iv) subjects without food allergies.
All volunteers are informed about the purpose of the study and the potential risk and provide their informed consent.
Subjects are randomized into two groups: active group (13M/36F) vs placebo group (13M/29F).
The main objective of this project is to test the efficacy of the 12-weeks consumption of a novel food (snack enriched with camelina Sativa oil) on the inflammatory status in older adults.
The primary and secondary endpoints are:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age over 65
- •Free-living
- •No food allergy
- •Apparent good health
- •Acceptance and sign of informed consent
排除标准
- •Age under 65
- •Living in a nursing home, extended care
- •Hospitalized
- •Presence food allergy
- •Without acceptance and sign of informed consent
- •Taking vitamin supplements/integration and/or omega 3 polyunsaturated fatty acids
结局指标
主要结局
Inflammatory status evaluation.
时间窗: Baseline (T0) and after 12 weeks of intervention (T1).
Investigation of changes in serum CRP levels (pg/mL) and serum levels of pro- and anti- inflammatory cytokines (TNF-α, pg/mL; TGF-beta1, pg/mL and TGF-beta2, pg/mL; IL-18 pg/mL).
次要结局
- Anthropometric parameters evaluation - weight(Baseline (T0).)
- Body composition evaluation.(Baseline (T0).)
- Glucidic profile evaluation - glycated haemoglobin levels(Baseline (T0) and after 12 weeks of intervention (T1).)
- Nutritional status evaluation - hyperhomocysteinemia(Baseline (T0) and after 12 weeks of intervention (T1).)
- Glucidic profile evaluation -glucose levels(Baseline (T0) and after 12 weeks of intervention (T1).)
- Glucidic profile evaluation - insulin levels(Baseline (T0) and after 12 weeks of intervention (T1).)
- Muscle strength evaluation.(Baseline (T0).)
- Glucidic profile evaluation - HOMA index(Baseline (T0) and after 12 weeks of intervention (T1).)
- Nutritional status evaluation - renal function(Baseline (T0) and after 12 weeks of intervention (T1).)
- Omega 3 polyunsaturated fatty acids evaluation.(Baseline (T0) and after 12 weeks of intervention (T1).)
- Anthropometric parameters evaluation - height and waist circumference(Baseline (T0).)
- Ponderal status evaluation(Baseline (T0).)
- Nutritional status evaluation - hepatic function(Baseline (T0) and after 12 weeks of intervention (T1).)
- Nutritional status evaluation.(Baseline (T0) and after 12 weeks of intervention (T1).)
- Fat distribution evaluation.(Baseline (T0).)
- Lipid panel parameters evaluation.(Baseline (T0) and after 12 weeks of intervention (T1).)
- Nutritional status evaluation - micronutrients(Baseline (T0) and after 12 weeks of intervention (T1).)
- Nutritional status evaluation - vitamins(Baseline (T0) and after 12 weeks of intervention (T1).)