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临床试验/NCT04602039
NCT04602039已完成不适用

The Anti-inflammatory Effects of Dairy Colostrum Neovite™ as a Dietary Supplement for Humans

Swansea University0 个研究点目标入组 23 人开始时间: 2016年7月21日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
23
主要终点
This project aimed to examine changes in insulin resistance in participants using dairy colostrum as a food supplement

研究概览

简要总结

Colostrum is the milk that is first produced by a mother after giving birth. It plays a key role in the normal early development of mammals by providing substances that are important for nutrition, immunological defence and healthy growth and development. Research has shown that the immunoglobulins, antimicrobial peptides and growth factors in dairy colostrum and early season milk from cows are nearly identical to human. After puberty our bodies begin the aging process, and gradually produce less immune and growth factors that resist disease and heal tissue. Colostrum is a natural source of these life-enhancing components. Research shows that colostrum supports immune function and can help use fat for fuel and optimise cellular reproduction. Colostrum is receiving an increasing amount of interest in the healthcare community because of the potential benefits it can offer to a variety of patient groups by boosting the body's immune response, encouraging growth and repair in the gut, stabilising gut microflora and supporting better nutritional absorption and muscle growth.

Diabetes is a chronic condition associated with significant morbidity and mortality predominantly from associated chronic diseases. Currently within the UK approximately 5% of NHS spend is in relation to type 2 diabetes alone. Within Wales, approximately £256 million is spent on the care of these patients. Estimates suggest that people with type 2 diabetes have the disease for approximately 10 years before diagnosis, during which complications become well established including dyslipidaemia and hypertension. Additionally, many of these people are overweight or obese before they develop diabetes. The prevalence of type 2 diabetes continues to increase despite recent advances in our understanding of the basic physiology of glucose control. There is a clear association between inflammation, insulin resistance and type 2 diabetes. We aim to target inflammation levels seen in those with impaired glucose homeostasis such as impaired fasting glucose (IFG) and impaired glucose tolerance (IGT), collectively called pre-diabetes.

详细描述

Colostrum is the milk that is first produced by a mother after giving birth. It plays a key role in the normal early development of mammals by providing substances that are important for nutrition, immunological defence and healthy growth and development. Research has shown that the immunoglobulins, antimicrobial peptides and growth factors in dairy colostrum and early season milk from cows are nearly identical to human. After puberty our bodies begin the aging process, and gradually produce less immune and growth factors that resist disease and heal tissue. Colostrum is a natural source of these life-enhancing components. Research shows that colostrum supports immune function and can help use fat for fuel and optimise cellular reproduction. Colostrum is receiving an increasing amount of interest in the healthcare community because of the potential benefits it can offer to a variety of patient groups by boosting the body's immune response, encouraging growth and repair in the gut, stabilising gut microflora and supporting better nutritional absorption and muscle growth.

Diabetes is a chronic condition associated with significant morbidity and mortality predominantly from associated chronic diseases. Currently within the UK approximately 5% of NHS spend is in relation to type 2 diabetes alone. Within Wales, approximately £256 million is spent on the care of these patients. Estimates suggest that people with type 2 diabetes have the disease for approximately 10 years before diagnosis, during which complications become well established including dyslipidaemia and hypertension. Additionally, many of these people are overweight or obese before they develop diabetes. The prevalence of type 2 diabetes continues to increase despite recent advances in our understanding of the basic physiology of glucose control. There is a clear association between inflammation, insulin resistance and type 2 diabetes. We aim to target inflammation levels seen in those with impaired glucose homeostasis such as impaired fasting glucose (IFG) and impaired glucose tolerance (IGT), collectively called pre-diabetes.

The focus of the work will be to investigate the effects of dairy colostrum as a food supplement on inflammatory processes and the potential role that it could play in the prevention of pre-diabetes developing into type 2 diabetes.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Prevention
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
是

入选标准

  • •both genders
  • •age 18-65 years
  • •no impaired glucose homeostasis (HbA1c <6.0% or <42mmol/mol) (Group 1)
  • •impaired fasting glucose (IFG) or impaired glucose tolerance (ITG) (HbA1c 6.0-6.5% or 42-48mmol/mol) (Group 2)
  • •type 2 diabetes (>6.5% or >48mmol/mol) (Group 3)

排除标准

  • •those who cannot give informed consent
  • •those who are lactose intolerant
  • •females who are pregnant or breastfeeding
  • •those with type 1 diabetes
  • •those with chronic kidney disease
  • •those taking GLP-1 agonists or DPP-4 inhibitors (gliptins)

研究组 & 干预措施

People without Diabetes

Experimental

A 4 week supply of a commercial dairy colostrum supplement (Neovite™) given to each participant.

干预措施: Bovine Colostrum (Dietary Supplement)

Participants with Pre-diabetes

Experimental

A 4 week supply of a commercial dairy colostrum supplement (Neovite™) given to each participant.

干预措施: Bovine Colostrum (Dietary Supplement)

Participants with Type 2 diabetes

Experimental

A 4 week supply of a commercial dairy colostrum supplement (Neovite™) given to each participant.

干预措施: Bovine Colostrum (Dietary Supplement)

结局指标

主要结局

This project aimed to examine changes in insulin resistance in participants using dairy colostrum as a food supplement

时间窗: before and after 28 days supplementation

insulin resistance (HOMA-IR)

次要结局

  • This project aimed to examine changes in inflammatory markers in participants using dairy colostrum as a food supplement(before and after 28 days supplementation)

研究者

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

Richard Bracken

Assoicate Professor

Swansea University

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