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临床试验/NCT06261775
NCT06261775进行中(未招募)不适用

Effect of Minimally Processed Animal Protein on Biomarkers for Cognitive Decline

South Dakota State University2 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2024年1月30日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
36
试验地点
2
主要终点
Concentration of phosphatidylcholine in blood

研究概览

简要总结

Minimally processed animal protein is a premier source of essential macro and micronutrients in the diet and is important, especially to older adults who are at increased risk of nutritional deficiency and age-related physiological changes. Our central hypothesis is that adding lean animal protein within a healthy diet following macronutrient recommendations for Americans will enhance nutrient adequacy and attenuate markers of cognitive decline. This is a retrospective study leveraging samples collected from the feeding trial NCT05581953. PI for both studies are the same.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Other
盲法
None

入排标准

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

入选标准

  • Generally, good health status based on one routine physical in the past 15 months, current health status
  • Normal HbA1C, weigh 110 lb or more
  • Age 65 years or more, generally healthy, all races and both sexes
  • Generally practicing a meat-based dietary pattern, do not have any special dietary requirements, and
  • Willingness to comply with the study protocol, including on-site meal consumption and sample/data collection.

排除标准

  • Medication usage, probiotic, long-term antibiotic, and tobacco/drug/alcohol use
  • Not on any special diet within 3 months of recruitment, and do not intend to lose weight
  • 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 affecting the ability to provide written informed consent
  • If they had not had a routine health checkup 12 months before recruitment.
  • If they were unwilling to abstain from taking nutritional supplements, alcohol, non-study foods, and beverages during the study period.

研究组 & 干预措施

Test

Experimental

Low UPF with Red meat

干预措施: Red meat-based meal (Other)

Test

Experimental

Low UPF with Red meat

干预措施: No meat diet (Other)

Control

Other

Low UPF no meat

干预措施: Red meat-based meal (Other)

Control

Other

Low UPF no meat

干预措施: No meat diet (Other)

结局指标

主要结局

Concentration of phosphatidylcholine in blood

时间窗: 8 weeks

Using Microplate Assay

次要结局

未报告次要终点

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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