Comparison Between Olive Oil and Palm Oil-enricHed chOCOlate Spreads (CHOCO) in Healthy Subjects: a Randomized, Double-blind, Cross-over Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Plasma Ceramides
研究概览
简要总结
This clinical trial aims to investigate if extra virgin olive oil (EVOO) or palm oil enriched chocolate spread snacks consumption lead to differential insulin resistance status in young, healthy subjects. Such effect includes difference in a) plasma ceramides, b) glucose metabolism markers, c) lipid profile, d) inflammatory markers, e) hunger/satiety hormonal markers and visual analogue scale.
详细描述
Exceeding intake of foods high in palmitic acid, abundant in Palm Oil, has been associated with lipotoxicity, a condition featured by high toxic lipids in the body such as ceramides, which ultimately can lead to insulin resistance and therefore to diabetes and increased cardiometabolic risk through the promotion of atheroma plaque formation.
On the other hand, foods high in oleic acid, rich in extra virgin olive oil EVOO and typical of the Mediterranean diet, has been related to reduced insulin resistance and inflammatory state, with proved protective effects against metabolic diseases such as diabetes, hypercholesterolemia and cardiovascular disease.
Therefore, this clinical trial aims to assess potential metabolic differences in relation to daily consumption of EVOO-enriched chocolate spread in comparison with a Palm oil-enriched chocolate spread.
The investigators, therefore, aimed to evaluate the impact of fourteen days consuming the two different oils added to the same chocolate spread in terms of the composition of plasma ceramides as the primary outcome; and as secondary outcomes, changes in glucose metabolism markers (Glucose, Insulin, HOMA-IR), in LDL, total cholesterol, Triglycerides, HDL levels, in inflammation Markers (CRP, IL-6, TNF-a) and in the appetite-regulating hormones (Leptin, Adiponectin, GLP-1, Ghrelin, PYY and Oxyntomodulin) and in the visual analogue scale (VAS) analysis.
Both chocolate spreads have an identical composition with the exception of fat content (EVOO vs. Palm Oil).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy volunteers of both genders.
- •Aged > 18 years.
- •Body mass index ranging from 18 to 29.99 kg/m
- •Subjects able to provide written informed consent.
排除标准
- •Diagnosis of diabetes. defined as per the Italian Society of Diabetology guidelines. fasting glucose twice greater than 126 mg / dL and/or random glucose greater than 200 mg / dL.
- •Subjects being treated with oral and/or injectable hypoglycemic and/or insulin-sensitizing agents
- •Subjects undergoing therapy with synthetic cholesterol-lowering agents (statins and/or fibrates) and/or cholesterol-lowering nutraceuticals (berberine and/or monacolin k)
- •Individuals with triglycerides greater than 200 mg/dL
- •Subjects with LDL greater than 159 mg/dL
- •Moderate or major renal impairment (and GFR <60 mL/min)
- •Hypertensive subjects and/or subjects being treated with antihypertensives
- •Subjects receiving omega 3 supplements.
- •Pregnancy and/or breastfeeding.
- •Coronary cardiovascular disease.
- •Stroke and heart failure.
- •Celiac disease.
- •Malabsorption.
- •Irritable bowel syndrome.
- •Chronic inflammatory bowel disease.
- •Present alcoholism or drug abuse or use of medicines whose dose may change during the study or when there is an intention to start a new therapy.
- •Individuals with an allergy to hazelnuts or any of the ingredients present in the chocolates under study.
- •Neurological or psychiatric pathologies
- •Subjects who cannot participate in the study for any reason
- •Infectious diseases such as HIV, hepatitis or chronic infections
- •Any uncontrolled endocrine pathology such as Cushing's. Acromegaly. etc.
- •Any existing cancer and/or lymphoma
- •Eating disorders such as anorexia and bulimia
- •Previous bariatric surgery or gastrectomy
- •Individuals with pacemakers
- •Not consuming the chocolate spread for more than three days
结局指标
主要结局
Plasma Ceramides
时间窗: At the end of the dietary interventional phase (each dietary interventional phase is 14 days)
Fasting Ceramides expressed in nmol
次要结局
- Plasma HOMA-IR (Homeostatic Model Assessment for Insulin Resistance)(At the end of the dietary interventional phase (each dietary interventional phase is 14 days))
- Plasma Tumor Necrosis Factor-alpha (TNF-alpha)(At the end of the dietary interventional phase (each dietary interventional phase is 14 days))
- Plasma Interleukin-6(At the end of the dietary interventional phase (each dietary interventional phase is 14 days))
- Plasma Glucagon Like Peptide-1 (GLP-1)(At the end of the dietary interventional phase (each dietary interventional phase is 14 days))
- Plasma Oxyntomodulin(At the end of the dietary interventional phase (each dietary interventional phase is 14 days))
- Plasma Insulin(At the end of the dietary interventional phase (each dietary interventional phase is 14 days))
- Plasma Glucose(At the end of the dietary interventional phase (each dietary interventional phase is 14 days))
- Plasma Low Density Lipoprotein (LDL)(At the end of the dietary interventional phase (each dietary interventional phase is 14 days))
- Plasma High Density Lipoprotein (HDL)(At the end of the dietary interventional phase (each dietary interventional phase is 14 days))
- Plasma C-reactive protein (CRP)(At the end of the dietary interventional phase (each dietary interventional phase is 14 days))
- Plasma Triglycerides(At the end of the dietary interventional phase (each dietary interventional phase is 14 days))
- Plasma Total Cholesterol(At the end of the dietary interventional phase (each dietary interventional phase is 14 days))
- Plasma Ghrelin(At the end of the dietary interventional phase (each dietary interventional phase is 14 days))
- Plasma Peptide YY (PYY)(At the end of the dietary interventional phase (each dietary interventional phase is 14 days))
- Plasma Leptin(At the end of the dietary interventional phase (each dietary interventional phase is 14 days))
- Visual Analogue Scale (VAS)(At the end of the dietary interventional phase (each dietary interventional phase is 14 days))
- Plasma Adiponectin(At the end of the dietary interventional phase (each dietary interventional phase is 14 days))
研究者
Silvia Manfrini
Head of the Metabolic Diseases Unit
Campus Bio-Medico University