Colostrum and Inflammation

NCT ID: NCT04602039

Last Updated: 2020-10-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 23 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-07-21
• Study Completion Date: 2016-11-29

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.

Conditions

Diabetes Mellitus

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

People without Diabetes

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

Group Type: EXPERIMENTAL

Bovine Colostrum

Intervention Type: DIETARY_SUPPLEMENT

Bovine colostrum (Neovite)

Participants with Pre-diabetes

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

Group Type: EXPERIMENTAL

Bovine Colostrum

Intervention Type: DIETARY_SUPPLEMENT

Bovine colostrum (Neovite)

Participants with Type 2 diabetes

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

Group Type: EXPERIMENTAL

Bovine Colostrum

Intervention Type: DIETARY_SUPPLEMENT

Bovine colostrum (Neovite)

Interventions

Bovine Colostrum

Bovine colostrum (Neovite)

Intervention Type: DIETARY_SUPPLEMENT

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Swansea University

OTHER

Sponsor Role: lead

Responsible Party

Richard Bracken

Assoicate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

IRAS190222

Identifier Type: -

Identifier Source: org_study_id