Effect of Consumption of Vegetable Protein-enriched Biscuits and Vitamin D Supplementation on the Progression of Sarcopenia in Elderly Subjects
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 74
- 试验地点
- 3
- 主要终点
- Change in Appendicular Skeletal Muscle Index (ASMI)
研究概览
简要总结
The ageing population makes it necessary to find effective strategies for the prevention of sarcopenia (the progressive loss of muscle mass and strength and a decline in physical performance) that can be counteracted with foods containing protein and adequate intake of vitamin D. This study will evaluate the effectiveness of consuming a food based on plant proteins and vitamin D supplementation. Intervention studies in humans conducted to date have mostly focused on the effect of animal proteins (mainly from whey) on disease progression. A study on the effect of pea proteins has not yet been conducted and will provide information on the effectiveness of these proteins in modulating markers linked to the disease. The effect on the gut microbiota will also be considered, as the existence of a gut-muscle axis has been suggested, in which microbial genera producing short-chain fatty acids have been linked to a positive effect on muscle mass through anabolic stimulation. Thus, the analysis of the modulation of the intestinal microbiota, through the dietary intervention proposed in this study, may represent a further step in research related to the prevention of this disease. Sarcopenic volunteers aged between 65 and 80 will be recruited to consume either a shortbread biscuit made with wheat flour enriched with hydrolysed pea protein and a vitamin D supplement in extra virgin olive oil, or a control biscuit and a placebo (extra virgin olive oil) for 12 weeks. The study will be randomised, parallel, single-blind. The effect of consuming the experimental biscuit and vitamin D supplementation compared to that of a traditional control biscuit and a placebo oil solution will be evaluated on certain markers related to sarcopenia. In particular, the following will be considered: muscle strength, measuring grip strength and leg strength (chair stand test); muscle mass through the measurement of appendicular muscle mass, and the calculation of the appendicular muscle mass index; physical performance using the Short Physical Performance Battery; the inflammatory response and other blood biomarkers related to sarcopenia. In addition, the following will be assessed: dietary habits through a food diary and quality of life through the SarQoL questionnaire. Finally, the effect of nutritional intervention on the modulation of the gut microbiota will be evaluated through 16S rRNA sequencing and bioinformatic analysis of the data.
详细描述
Sarcopenia, characterized by the age-related loss of muscle mass, strength, and physical performance, is a growing public health concern given the global aging population. Physical activity-the standard treatment-is often not feasible for frail or bedridden elderly individuals, highlighting the need for alternative strategies. Nutritional interventions, particularly those involving protein and vitamin D supplementation, have shown promise in managing sarcopenia.
This randomized, single-blind, parallel-design clinical trial aims to evaluate the effect of consuming a shortbread biscuit enriched with hydrolyzed pea protein, combined with a daily dose of vitamin D3 (20 μg/day, 800 IU/day), on muscle mass, muscle strength, physical performance, and gut microbiota composition in sarcopenic individuals aged 65-80 years. The study will enroll 74 participants meeting specific inclusion criteria.
Participants will be randomly assigned to one of two groups:
- Intervention Group: Receives a 50 g daily portion of a functional biscuit enriched with hydrolyzed pea protein, and 2 drops/day of a vitamin D3 supplement (providing 20 μg/day).
- Control Group: Receives a similar biscuit without added protein and a placebo oil (extra virgin olive oil) in replace of vitamin D3.
The intervention will last for 12 weeks. Measurements will be taken at baseline, mid-point (6 weeks), and study end (12 weeks), including handgrip strength, chair stand test, bioimpedance-based muscle mass, and SPPB. Blood samples will be analyzed for markers related to inflammation (e.g., CRP, IL-6, TNF-α), oxidative stress (oxLDL), anabolic signaling (IGF-1), and vitamin D status (25-hydroxycholecalciferol), among others. Gut microbiota composition and short-chain fatty acid (SCFA) production will be assessed via stool sample analysis and 16S rRNA sequencing.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 80 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Given the multifactorial, heterogeneous nature of sarcopenia, volunteers will be enrolled if they meet at least one of the following three diagnostic criteria :
- •Ishii equation values: patients with a score ≥105 for males and ≥120 for females will be included. The Ishii screening test is a widely used method that estimates the probability of sarcopenia using a score derived from an equation based on three variables: age, grip strength, and calf circumference.
- •Appendicular skeletal muscle mass index (ASMI): <7.0 kg/m2 for males and <5.5 kg/m2 for females.
- •Short physical performance battery score ≤8
- •In addition, the following inclusion criteria are considered:
- •Body mass index ≥19 <30 kg/m2
- •Ability to act
排除标准
- •Age <65 or >80 years;
- •Body mass index <19 or ≥30 kg/m²;
- •Diagnosis of cancer within the previous five years;
- •Regular intake of vitamin D supplements;
- •Dysphagia and difficulty chewing;
- •Allergy or other intolerances to gluten;
- •Allergy to eggs;
- •Intestinal disorders (Crohn's disease, ulcerative colitis, bacterial overgrowth syndrome, constipation, coeliac disease, irritable bowel syndrome) that could affect the gut microbiota;
- •Pacemaker recipients;
- •Acute inflammation (CRP >10 mg/L);
- •Anaemia (haemoglobin <13 g/dL in men; <12 g/dL in women);
- •Renal failure (glomerular filtration rate (GFR) >45 mL/min/1.73 m²);
- •Chronic liver disease (transaminases < 40 IU in men, < 35 IU/L in women);
- •Inability to act
研究组 & 干预措施
Protein-enriched biscuit + Vitamin D3
Participants will consume daily one portion (50 g) of experimental biscuits made with wheat flour and pea protein hydrolysate, and take 2 drops of vitamin D3 supplement in extra virgin olive oil.
干预措施: Vitamin D3 supplement (Dietary Supplement)
Protein-enriched biscuit + Vitamin D3
Participants will consume daily one portion (50 g) of experimental biscuits made with wheat flour and pea protein hydrolysate, and take 2 drops of vitamin D3 supplement in extra virgin olive oil.
干预措施: Protein-enriched biscuits (Other)
Control Biscuit + Placebo Oil
Participants will consume daily one portion (50 g) of control biscuits (same recipe without pea protein hydrolysate), and take 2 drops of placebo oil (extra virgin olive oil without vitamin D3).
干预措施: Control biscuit (Other)
Control Biscuit + Placebo Oil
Participants will consume daily one portion (50 g) of control biscuits (same recipe without pea protein hydrolysate), and take 2 drops of placebo oil (extra virgin olive oil without vitamin D3).
干预措施: Placebo oil (Other)
结局指标
主要结局
Change in Appendicular Skeletal Muscle Index (ASMI)
时间窗: Screening, baseline, week 6 and week 12 (end of the treatment)
ASMI calculated as appendicular skeletal muscle mass in kilograms divided by height in meters squared (kg/m²). ASM and height will be measured separately and combined using this formula: "kg/m²". ASMI values \<7 kg/m2 for men, and \<5.5 kg/m2 for women indicate the condition of sarcopenia as indicated by the European Working Group on Sarcopenia in Older People.
次要结局
- Muscle strenght(Screening, baseline, week 6 and week 12 (end of the treatment))
- Physical performance (SPPB score)(Screening, baseline, week 6 and week 12 (end of the treatment))
- C-Reactive protein (CRP)(Baseline, week 6 and week 12 (end of the treatment))
- Nutritional habits(Enrollment)
- Gut micorbiome modulation and metabolites(Baseline at at week 12 (end of the treatment))
- Nutritional intake(Baseline, week 6 and week 12 (end of the treatment))
- Quality of life of sarcopenic patients(Baseline, week 6 and week 12 (end of the treatment))
- Mini Nutritional Assessment (MNA®)(At the screening)
- Mini Mental State Examination (MMSE)(At the screening)
- Body mass index (BMI)(screening, baseline, week 6, week 12 (end of the treatment))
- Interleukin-6 (IL-6)(baseline, week 6, week 12 (end of the treatment))
- Tumor Necrosis Factor-alpha (TNF-α)(baseline, week 6, week 12 (end of the treatment))
- Leptin(baseline, week 6, week 12 (end of the treatment))
- IGF-1(Baseline, week 6, week 12 (end of the treatment))
- Albumin(baseline, week 6, week 12 (end of the treatment))
- Oxidized LDL (oxLDL)(baseline, week 6 and week 12 (end of the treatment))
- 25OH-D (Total 25-OH Vitamin D)(baseline, week 6, week 12 (end of the treatment))
- Human Agrin (C-terminal fragment)(baseline, week 6, week 12 (end of the treatment))
- Triglyceride (TG)(baseline, week 6, week 12 (end of the treatment))