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临床试验/NCT05577858
NCT05577858进行中(未招募)不适用

Effect of a Pulse-based USDA-diet on Gut Microbial Metabolites and Biomarkers of Healthspan: A 18-week Randomized Controlled Crossover Feeding Study in Older Adults

South Dakota State University2 个研究点 分布在 1 个国家目标入组 76 人开始时间: 2022年11月15日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
76
试验地点
2
主要终点
Ferritin

研究概览

简要总结

Plant-based diets are naturally low in Methionine (Met), and also low in precursor molecules (e.g L-carnitine, choline, betaine, etc.) producing microbiota-mediated proatherogenic TMAO. Among plant proteins, pulses are rich in micronutrients, and dietary fibers, making them ideal for microbiome-stimulating, nutrient-dense, healthful dietary patterns. However, daily pulse intake remains low at 8% in America despite recommendations by DGA, a resource to guide health promotion across communities. A significant body of preclinical data, waiting to be translated to humans, suggests that dietary Met restriction can trigger beneficial metabolic and anti-inflammatory adaptations leading to improved chronic health and longevity. The central hypothesis is that a pulse-protein-based healthy diet can be simultaneously equivalent to omnivorous diets in protein content and yet naturally lower in Met and TMAO to improve glycemic control, body composition, and immunometabolic flexibility to reduce the risk of chronic diseases and improve healthspan. The goal is to systematically elucidate for the first time the effects of a lacto-vegetarian feeding pattern with pulses as the primary protein source on a comprehensive panel of ~500 traditional and next-generation biomarkers of health, and assess the role of the gut microbiota in mediating such effects. We also aim to interrogate the potential concern about the lower bioavailability of non-heme iron from pulses.

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
Double (Care Provider, Outcomes Assessor)

盲法说明

Blinding will be implemented to the extent possible. A researcher, unaware of the study goals and not involved with downstream data analyses will use a 1:1 block randomization to allocate participants to the diets in the first arm. Food service personnel (care provider) will not be aware of study goals and allocations. Metabolomic assays will be run in a blinded manner.

入排标准

年龄范围
60 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Generally good health status based on routine physical in the past 12 months, current healthy status
  • Normal HbA1C, not underweight
  • Age 60 years or more, all races, both sexes and all education level
  • Do not have any special dietary requirements and willing to consume vegetarian diet
  • Willingness to comply with the study protocol, including on-site meal consumption and sample/data collection.

排除标准

  • Probiotic, long-term antibiotic, and tobacco/drug/alcohol use
  • Not on any special diet within 3 months of recruitment
  • Impaired kidney functions
  • Active history of cancer, diabetes, heart, liver, and kidney diseases
  • Major gastrointestinal disorders in the past 3 months
  • History of heart attacks or stroke
  • Unable to meet in-person visit requirements for dining, picking up meals, and tests
  • Any mental health condition that would affect the ability to provide written informed consent.
  • If they had not had a routine health checkup during the 12 months prior to recruitment.
  • If they were unwilling to abstain from taking certain nutritional supplements, alcohol, or non-study foods during the study period.

结局指标

主要结局

Ferritin

时间窗: 16 weeks

Microplate assay

Concentration of TMAO in blood

时间窗: 16 weeks

Using LC/MS based method method

Fasting blood glucose concentration in blood

时间窗: 16 weeks

Using Glucometer

次要结局

  • Concentration of Fasting insulin in blood(16 weeks)
  • Body weight in kilograms(16 weeks)
  • Concentration of CRP in blood(16 weeks)
  • Gut microbiota composition and diversity(16 weeks)
  • Fat and lean mass in kg using DXA for body composition measures(16 weeks)
  • Concentration of sulfur containing amino acids in blood(16 weeks)
  • Digestible indispensable amino acid score using different amino acid concentrations(16 weeks)
  • Concentration of IGF-1 in blood(16 weeks)
  • Concentration of IGF-BP3 in blood(16 weeks)
  • Peak heights of several complex lipids panel using metabolomics technique(16 weeks)
  • Concentration Short-chain fatty acid panel in stool(16 weeks)
  • Peak heights of several Biogenic amines panel using metabolomics technique(16 weeks)
  • Muscle strength using Isokinetic muscle testing(16 weeks)
  • Balance assessment using balance(16 weeks)
  • Grip force per kg mass(16 weeks)
  • Blood pressure in mm Hg(16 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Moul Dey

Professor

South Dakota State University

研究点 (2)

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