Colostrum and Inflammation

Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04602039
• Other study ID #: IRAS190222
• Status: Completed
• Phase: N/A
• Start date: July 21, 2016
• Est. completion date: November 29, 2016

Study information

• Verified date: October 2020
• Source: Swansea University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: November 29, 2016
• Est. primary completion date: November 29, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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)

Related Conditions & MeSH terms

• Diabetes Mellitus

Intervention

Dietary Supplement:
• Bovine Colostrum
Bovine colostrum (Neovite)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Swansea University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	This project aimed to examine changes in insulin resistance in participants using dairy colostrum as a food supplement	insulin resistance (HOMA-IR)	before and after 28 days supplementation
Secondary	This project aimed to examine changes in inflammatory markers in participants using dairy colostrum as a food supplement	to measure CRP	before and after 28 days supplementation
Secondary	This project aimed to examine changes in inflammatory markers in participants using dairy colostrum as a food supplement	to measure IL6	before and after 28 days supplementation
Secondary	This project aimed to examine changes in inflammatory markers in participants using dairy colostrum as a food supplement	to measure iFABP	before and after 28 days supplementation