Colostrum and Inflammation

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

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.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus
• Intervention / Treatment: Dietary supplement: Bovine Colostrum

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.

• Study Type: Interventional
• Enrollment (Actual): 23
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: People without Diabetes; A 4 week supply of a commercial dairy colostrum supplement (Neovite™) given to each participant.	Dietary supplement: Bovine Colostrum; Bovine colostrum (Neovite)
Experimental: Participants with Pre-diabetes; A 4 week supply of a commercial dairy colostrum supplement (Neovite™) given to each participant.	Dietary supplement: Bovine Colostrum; Bovine colostrum (Neovite)
Experimental: Participants with Type 2 diabetes; A 4 week supply of a commercial dairy colostrum supplement (Neovite™) given to each participant.	Dietary supplement: Bovine Colostrum; Bovine colostrum (Neovite)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: Swansea University

Study record dates

Study Major Dates

• Study Start (Actual): July 21, 2016
• Primary Completion (Actual): November 29, 2016
• Study Completion (Actual): November 29, 2016

Study Registration Dates

• First Submitted: August 24, 2017
• First Submitted That Met QC Criteria: October 20, 2020
• First Posted (Actual): October 26, 2020

Study Record Updates

• Last Update Posted (Actual): October 26, 2020
• Last Update Submitted That Met QC Criteria: October 20, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Keywords: diabetes; colostrum
• Other Study ID Numbers: IRAS190222

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No