Clinical trial NCT04602039: Colostrum and Inflammation
Official title: The Anti-inflammatory Effects of Dairy Colostrum Neovite™ as a Dietary Supplement for Humans
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus
Keywords: diabetes
colostrum
Lead sponsor: Swansea University
Sponsor class: OTHER
First posted: 2020-10-26
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This was a non-randomised control trial involving individuals split into 3 groups (healthy, prediabetes, type 2 diabetes) that all received colostrum for 28 days.
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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)

Exclusion Criteria:

* 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)

Primary outcomes:
measure: This project aimed to examine changes in insulin resistance in participants using dairy colostrum as a food supplement
timeFrame: before and after 28 days supplementation
Secondary outcomes:
measure: This project aimed to examine changes in inflammatory markers in participants using dairy colostrum as a food supplement
timeFrame: before and after 28 days supplementation
measure: This project aimed to examine changes in inflammatory markers in participants using dairy colostrum as a food supplement
timeFrame: before and after 28 days supplementation
measure: This project aimed to examine changes in inflammatory markers in participants using dairy colostrum as a food supplement
timeFrame: before and after 28 days supplementation
Other outcomes:
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