Foods Such as Virgin Olive Oil Rich in Phenolic Compounds, and Prebiotic Supplementation: Dietary Strategy to Tackle Sarcopenia in Early Elderly Subjects (FOOP-Sarc)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 39
- 试验地点
- 2
- 主要终点
- Change in muscle mass
研究概览
简要总结
The main objective of the present study is to add knowledge of the potential health effects and mechanism of action by a dietary strategy based on a VOO rich in phenolic compounds (156 mg hydroxytyrosol and tyrosol/kg oil) alone or combination with prebiotic supplementation based on fructooligosaccharides (FOS) and inulin to tackle sarcopenia by improving skeletal muscle mass and function and CVD risk factors in early elderly (60-80 years) home-dwelling sarcopenic subjects.
The specific objectives:
- To determine the compliance food intake biomarkers of VOO in 24h urine samples and prebiotic intake in faecal samples.
- To evaluate the effect of the NFOC-diet supplemented by VOO rich in phenolic compounds (156 mg hydroxytyrosol and tyrosol/kg oil) alone or in combination with prebiotic supplementation (FOS and inulin) on the improvement of muscle mass, muscle performance, gait performance, cardiovascular disease risk factors (inflammation, oxidation and endothelial function), and gut microbiota, in sarcopenic young-elderly subjects.
- To assess the mechanisms of action of the NFOC-diet supplemented by VOO rich in phenolic compounds (156 mg hydroxytyrosol and tyrosol/kg oil) alone or in combination with prebiotic supplementation (FOS and inulin) involved in the development of sarcopenia and cardiovascular disease in vivo and in vitro cellular models.
- To determine if the effects achieved after the intervention (12 weeks of intervention) will be sustained 12 weeks after the FOOP-Sarc intervention cessation (12 weeks of intervention + 12 weeks of follow-up), by assessing the sarcopenia and CVD risk factors in sarcopenic early elderly subjects.
- To co-create nutritional and physical activity recommendations of FOOP-Sarc study based on sarcopenia improvement by a sample of volunteers of the FOOP-Sarc study, and to assess the adherence and the effectivity of the recommendations, in comparison to standard recommendations created by researchers, the satisfaction and engagement experience in a co-creation process, and the usability of recommendations.
详细描述
The prebiotic supplementation about FOS and inulin was related to gut microbiota transformation an increase in handgrip strength and a reduction of exhaustion in older adults over 65 years old.
In the role of a nutritional intervention for the treatment of sarcopenia, an adequate intake of protein, especially leucine, vitamin D and antioxidant nutrients are recommended. In particular, dietary protein is a key anabolic stimulus for muscle protein synthesis. Moreover, food such as, virgin olive oil (VOO) can be involved in sarcopenia, by modulation of pro-inflammatory cytokines and could attenuate sarcopenic symptomology.
On the other hand, physical activity (PA) is an important aspect to avoid loss of muscle mass, for this reason, in sarcopenic subjects it is recommended to spend 150 min/week of moderate to vigorous physical activity.
A total of 39 home-dwelling early elderly volunteers will be included in the intervention (13 in each arm of the intervention). The total duration of the study will be 24 weeks (12-week period of dietary-lifestyle treatment and a 12-week period of follow-up after intervention cessation). Additionally, a total of 13 home-dwelling early elderly volunteers will be included in the co-creation process. Specifically, 7 home-dwelling early elderly volunteers will participate in the co-ideation and co-design steps. Additionally, 6 home-dwelling early elderly volunteers will participate in the co-implementation and comparison of recommendations (3 in each arm of intervention). The sample of volunteers that will co-implement will be randomized and different from the sample of volunteers that will co-ideate and co-design the recommendations. The co-evaluation step will include all 13 volunteers from the different steps of the co-creation process.
During the preliminary co-creation phase, there will be 5 visits over 6 weeks. A screening visit (V0) and one visit for each co-creation stage (co-ideation [V1], co-design [V2], co-implementation [V3] and co-evaluation [V4]). The volunteers who participated in the co-ideation and co-design stages had a total of 4 visits (V0, V1, V2 and the co-evaluation [V4] at the end of the co-design stage). The volunteers who participated in the co-implementation stage had a total of 3 visits (V0, V3 and V4).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 60 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Men and women with and age equal to or greater than 60 years and until 80 years.
- •Written informed consent provided before the initial visit.
- •Sarcopenia assessment: low muscle strength based on grip dynamometry, kg (men <30 kg; women <20 kg) or low skeletal muscle mass index (SMI) based on bioimpedance analysis (BIA), kg/m2 (men <8,87 kg/m2; women <6,42 kg/m2) or low physical performance or physical function based on 4m gait speed, m/s (≤0,8 m/s)
排除标准
- •Type 2 or insulin-dependent diabetes diagnosed.
- •Anemia (hemoglobin ≤13 g/dL in men and ≤12 g/dL in women).
- •Intestinal malabsorption diseases.
- •Fructose and/or sucrose intolerance.
- •Malnutrition (assessed by albumin <3,5 g/dl).
- •Renal diseases.
- •Chronic alcoholism.
- •Current or past participation in a clinical trial or consumption of a research product in the 30 days prior to inclusion in the study.
- •Institutionalized elderly.
- •Failure to follow the study guidelines.
结局指标
主要结局
Change in muscle mass
时间窗: Visit 1 (week 0), visit 5 (week 12), visit 6 (week 24)
The change in muscle mass will be assess by the change in skeletal muscle mass index (kg/m2) measured by segmental multifrequency body composition analyser (TANITA MC-780MA; Tanita Corp., Tokyo, Japan)
次要结局
- Body-weight(Visit 0 (week -1), visit 1 (week 0), visit 5 (week 12), visit 6 (week 24))
- Body Mass Index(Visit 0 (week -1), visit 1 (week 0), visit 5 (week 12), visit 6 (week 24))
- Height(Visit 0 (week -1), visit 1 (week 0), visit 5 (week 12), visit 6 (week 24))
- Body weight composition(Visit 0 (week -1), visit 1 (week 0), visit 5 (week 12), visit 6 (week 24))
- Sarcopenia assessment_skeletal muscle strength(Visit 0 (week -1), visit 1 (week 0), visit 5 (week 12), visit 6 (week 24))
- Waist circumference(Visit 0 (week -1), visit 1 (week 0), visit 5 (week 12), visit 6 (week 24))
- Dietary compliance markers(Visit 1 (week 0), visit 5 (week 12), visit 6 (week 24))
- Oxidative biomarkers_Oxidized LDL(Visit 1 (week 0), visit 5 (week 12), visit 6 (week 24))
- Oxidative biomarkers_Superoxide Dismutase(Visit 1 (week 0), visit 5 (week 12), visit 6 (week 24))
- Sarcopenia assessment_muscle mass(Visit 0 (week -1), visit 1 (week 0), visit 5 (week 12), visit 6 (week 24))
- Sarcopenia assessment_muscle physical performance(Visit 0 (week -1), visit 1 (week 0), visit 5 (week 12), visit 6 (week 24))
- Compliance of physical activity recommendations(Visit 1 (week 0), visit 2 (week 3), visit 3 (week 6), visit 4 (week 9) visit 5 (week 12), visit 6 (week 24))
- Compliance of the dietary recommendations(Visit 1 (week 0), visit 5 (week 12), visit 6 (week 24))
- Specific phenolic compounds_dietary compliance markers(Visit 1 (week 0), visit 5 (week 12), visit 6 (week 24))
- Phenolic metabolites_dietary compliance markers(Visit 1 (week 0), visit 5 (week 12), visit 6 (week 24))
- Sarcopenia and Quality of life(Visit 1 (week 0), visit 5 (week 12), visit 6 (week 24))
- Vascular parameters_blood pressure(Visit 1 (week 0), visit 5 (week 12), visit 6 (week 24))
- Endothelial dysfunction markers(Visit 1 (week 0), visit 5 (week 12), visit 6 (week 24))
- Fasting blood glucose (FBG)(Visit 1 (week 0), visit 5 (week 12), visit 6 (week 24))
- Lipid profile(Visit 1 (week 0), visit 5 (week 12), visit 6 (week 24))
- Insulin(Visit 1 (week 0), visit 5 (week 12), visit 6 (week 24))
- Homeostasis model assessment index (HOMA index)(Visit 1 (week 0), visit 5 (week 12), visit 6 (week 24))
- Apolipoproteins(Visit 1 (week 0), visit 5 (week 12), visit 6 (week 24))
- Apolipoproteins ratio(Visit 1 (week 0), visit 5 (week 12), visit 6 (week 24))
- Vascular parameters_endothelial function(Visit 1 (week 0), visit 5 (week 12), visit 6 (week 24))
- Vascular parameters_pulse pressure(Visit 1 (week 0), visit 5 (week 12), visit 6 (week 24))
- Endothelin(Visit 1 (week 0), visit 5 (week 12), visit 6 (week 24))
- Oxidative biomarkers_Glutathione peroxidase(Visit 1 (week 0), visit 5 (week 12), visit 6 (week 24))
- Inflammation biomarkers_High sensitivity C-reactive protein(Visit 1 (week 0), visit 5 (week 12), visit 6 (week 24))
- Inflammation biomarkers_interleukine-6(Visit 1 (week 0), visit 5 (week 12), visit 6 (week 24))
- Inflammation biomarkers_uric acid(Visit 1 (week 0), visit 5 (week 12), visit 6 (week 24))
- Inflammation biomarkers_tumour necrosis factor-α(Visit 1 (week 0), visit 5 (week 12), visit 6 (week 24))
- Renal function_creatinine(Visit 1 (week 0), visit 5 (week 12), visit 6 (week 24))
- Renal function_glomerular filtration rate(Visit 1 (week 0), visit 5 (week 12), visit 6 (week 24))
- Endocrine system(Visit 1 (week 0), visit 5 (week 12), visit 6 (week 24))
- Proteome profiling(Visit 1 (week 0), visit 5 (week 12), visit 6 (week 24))
- Gut microbiota_phyla composition and functionality(Visit 1 (week 0), visit 5 (week 12), visit 6 (week 24))
- Gut microbiota_short chain fatty acids(Visit 1 (week 0), visit 5 (week 12), visit 6 (week 24))
- wasting and turnover(Visit 1 (week 0), visit 5 (week 12), visit 6 (week 24))
- Muscle mass ultrasound assessment(Visit 1 (week 0), visit 5 (week 12), visit 6 (week 24))
- Muscle mass isokinetic assessment(Visit 1 (week 0), visit 5 (week 12))
- Frailty(Visit 1 (week 0), visit 5 (week 12), visit 6 (week 24))
研究者
Rosa Sola
Full Professor, Dr.
University Rovira i Virgili