Deciphering the Role of a Low Protein Diet in Disease Control in Acromegalic Patients
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Change in disease related hormones
研究概览
简要总结
Since protein and AAs are master regulator of GH and IGF-I secretion, we hypothesized that a low protein diet could reduce GH and IGF-I levels in acromegalic patients in addition to conventional therapy. Furthermore, we aim to explore metabolomic, microbiota, and micro-vesicle fingerprints of GH hypersecretion during conventional therapy and after a low protein diet
详细描述
Nutrients are crucial modifiers of the GH/IGF-I axis. In particular, a close cross-talk between proteins and amino acids (AAs) and GH/IGF-I secretion exists.
Both AAs and proteins affect GH secretion. AAs stimulate GH secretion upon oral administration, with different potency among studies, being the combination of arginine and lysine the most powerful. Soy proteins also stimulate GH secretion when ingested either as hydrolysed proteins or free AAs. Furthermore, the acute GH response to AAs ingestion may be influenced by the daily amount of dietary protein/AAs consumption: diets high in proteins apparently increase basal GH levels.
AAs and proteins have a positive effect on IGF-I secretion as well. In general, high levels of proteins, especially animal and dairy proteins, and consumption of branched chain amino acids (BCAAs) increase serum IGF-I levels.
Considering pathological GH conditions, metabolomic analysis of acromegalic patients suggests that the main metabolic fingerprint of GH hypersecretion is a reduction in BCAAs, related to the disease activity. Moreover, there is evidence that GH, rather than IGF-I, is the main mediator of such metabolic fingerprint, which may be related to increased uptake of BCAAs by the muscles, increased gluconeogenesis, and raised consumption of BCAAs.
Thus, in acromegaly, a tailored diet is a further strategy that may contribute to blunt GH/IGF-I secretion. Indeed, some authors recently suggested that "personalized" or "precision" nutrition in some conditions and diseases could have an impact on their phenotype, combining dietary recommendations with individual's genetic makeup, metabolic and microbiome characteristics, and environment. However, studies on precision nutrition in acromegaly are still in a neonatal era.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18/65
- •Diagnosis of Acromegaly
- •In therapy with somatostatin analogues
排除标准
- •pregnancy or lactation
- •alchool or drugs abuse
- •Hematological diseases
结局指标
主要结局
Change in disease related hormones
时间窗: Change from Baseline GH, IGF-1, IGFBP1, IGFBP3 blood levels at 15 days, 30 days, 45 days, 60 days
Variation of GH, IGF-1, IGFBP1, IGFBP3 hormones
次要结局
- Change in weight(Change from Baseline BMI at 15 days, 30 days, 45 days, 60 days)
- Change in body circumferences(Change from Baseline circumferences at 15 days, 30 days, 45 dyas, 60 days)
- Change in metabolic control(Change from Baseline lipid profile at 60 days)
- Change in kidney profile(Change from Baseline Serum Creatinin at 15 days, 30 days, 45 days, 60 days)
- Change in liver profile(Change from Baseline Serum Creatinin at 15 days, 30 days, 45 days, 60 days)
- Change in uric acid(Change from Baseline uric acid in blood at 15 days, 30 days, 45 days, 60 days)
- Change in blood count(Change from Baseline blood count at 15 days, 30 days, 45 days, 60 days)
- Change in microbiota(Change from Baseline of prevalence of microbiota phyla at 15, 30 days, 45 days, 60 days)
- Change in basal metabolic rate(Change from Baseline basal metabolic rate at 60 days)
- Change in microvesicles(Change from Baseline microvesicles levels s at 15, 30 days, 45 days, 60 days)
- Change in body composition(Change from Baseline fat mass% at 60 days)
- Change in omics profile(Change from Baseline omic profile of stools at 15, 30 days, 45 days, 60 days)
研究者
Flavia Prodam
Associated Prof. in Clinical Nutrition and MD
Azienda Ospedaliero Universitaria Maggiore della Carita