Colostrum and Inflammation

NCT04602039 | Completed

• 1 other identifier: IRAS190222
• Study Type: interventional
• Target: 23
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Diabetes Mellitus

Keywords

diabetes; colostrum

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• This project aimed to examine changes in inflammatory markers in participants using dairy colostrum as a food supplement

  before and after 28 days supplementation

• This project aimed to examine changes in inflammatory markers in participants using dairy colostrum as a food supplement

  before and after 28 days supplementation

• This project aimed to examine changes in inflammatory markers in participants using dairy colostrum as a food supplement

  before and after 28 days supplementation

Study Arms (3)

People without Diabetes

EXPERIMENTAL

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

Dietary Supplement: Bovine Colostrum

Participants with Pre-diabetes

EXPERIMENTAL

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

Dietary Supplement: Bovine Colostrum

Participants with Type 2 diabetes

EXPERIMENTAL

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

Dietary Supplement: Bovine Colostrum

Interventions

Bovine Colostrum DIETARY_SUPPLEMENT

Bovine colostrum (Neovite)

Participants with Pre-diabetes; Participants with Type 2 diabetes; People without Diabetes

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Swansea University: lead

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoicate Professor

Model Details: 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.

Study Record Dates

• First Submitted: August 24, 2017
• First Posted: October 26, 2020
• Study Start: July 21, 2016
• Primary Completion: November 29, 2016
• Study Completion: November 29, 2016
• Last Updated: October 26, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share