Effects of A1 versus A2 milk on cardiometabolic risk in overweight and obese Australians

• Register: ANZCTR
• Last refreshed on: 3 February 2020
• Main ID: ACTRN12617000403336
• Date of registration: 17/03/2017
• Prospective Registration: Yes
• Primary sponsor: Curtin University
• Public title: Effects of A1 versus A2 milk on cardiometabolic risk in overweight and obese Australians
• Scientific title: Overweight and obese Australians and the effects of A1 beta-casein versus A2 beta-casein on human cardiometabolic risk factors.
• Date of first enrolment: 25/02/2019
• Target sample size: 140
• Recruitment status: Recruiting
• URL: https://anzctr.org.au/ACTRN12617000403336.aspx
• Study type: Interventional
• Study design: Purpose: Treatment; Allocation: Randomised controlled trial; Masking: Blinded (masking used);Assignment: Parallel;Type of endpoint: Efficacy;
• Phase: Not Applicable

Countries of recruitment

Australia

Contacts

• Name: Dr Suleen Ho

• Name: Dr Suleen Ho

Key inclusion & exclusion criteria

Inclusion criteria:
overweight or obese (BMI: 25-40 kg/m2)
willing to consume 750 ml of milk/day

Exclusion criteria: Milk allergy, pregnancy and lactation, diabetes, current habitual opioid consumption and smokers

Age minimum: 18 Years
Age maximum: 70 Years
Gender: Both males and females

Health Condition(s) or Problem(s) studied

Overweight and obesity;Cardiometabolic risk factors related to A1 beta-casein;Gastrointestinal symptoms related to A1 beta-casein;
Overweight and obesity
Cardiometabolic risk factors related to A1 beta-casein
Gastrointestinal symptoms related to A1 beta-casein

Inflammatory and Immune System - Other inflammatory or immune system disorders

Cardiovascular - Diseases of the vasculature and circulation including the lymphatic system

Diet and Nutrition - Obesity

Intervention(s)

All participants will undergo a washout period of 2 weeks during which they will replace all dairy with rice milk. Other dairy containing product consumption will be restricted.

Intervention 1: 250ml three times a day (750 ml/day) A1A2 beta-casein Milk for 12 weeks
Intervention 2: 250ml three times a day (750 ml/day) A2A2 beta-casein Milk for 12 weeks

Adherence will be monitored via a milk intake calendar

Primary Outcome(s)

Antibodies to oxidised LDL measured by ELISA[Pre-washout, baseline and 12 weeks.]

Fasting serum triglyceride[Pre-washout, baseline and 12 weeks.]

Fasting serum cholesterol[Pre-washout, baseline and 12 weeks.]

Secondary Outcome(s)

Executive Functioning will be assessed by the Subtle Cognitive Impairment Test (SCIT)[Baseline and 12 weeks]

Fasting serum inflammatory markers (Glutathione, MPO, IL-4, IL-6, IL-8, CRP, TNF-alpha, IFN-gamma and TGF-beta1[Pre-washout, baseline and 12 weeks.]

Fasting whole blood Hba1C[Pre-washout, baseline and 12 weeks.]

Gut inflammation measured by assesing faecal calprotectin with a single step enzyme linked immunosorbant assay (ELISA)[Baseline and 12 weeks]

Gut permeability measured by dual sugar test (Lactulose/Mannitol)[Baseline and 12 weeks]

Hip circumference will be taken at the largest circumference of the lower abdomen with a tape measure.[Pre-washout, baseline and 12 weeks]

Body weight will be recorded in light clothing without shoes with a Body Composition Monitor (Omron Healthcare, Kyoto, Japan)[Pre-washout, baseline and 12 weeks]

Fasting serum insulin[Pre-washout, baseline and 12 weeks.]

Psychological health (quality of life, psychological well-being, self-rated health, and anxiety and depression) will be measured using previously-validated self-report psychometric inventories.[Baseline and 12 weeks]

Body composition measured by dual-energy X-ray absorptiometry (DXA)[Baseline and 12 weeks]

Waist circumference will be measured in the standing position at the narrowest area between the lateral lower rib and the iliac crest with a tape measure.[Pre-washout, baseline and 12 weeks]

Fasting serum leptin[Pre-washout, baseline and 12 weeks.]

Satiety will be assessed by 100 mm Visual Analogue Scale (VAS) questionnaires[Baseline and 12 weeks]

Fasting serum glucose[Pre-washout, baseline and 12 weeks.]

Gut microbiome will be analysed from faecal samples[Baseline and 12 weeks]

Arterial stiffness assessed by pulse contour analysis using the Pulse Trace PCA 2 (Carefusion, NSW, Australia)[Pre-washout, baseline and 12 weeks]

A1A2, A2A2 and Rice milk tolerance measured by GI symptom report diary[Baseline, 6 weeks and 12 weeks]

Blood pressure measured by automated, calibrated sphygmomanometer[Pre-washout, baseline and 12 weeks]

Fasting serum Non-Esterified Fatty Acids (NEFA)[Pre-washout, baseline and 12 weeks.]

Plasma BCM-7 will be assessed by ELISA and cross-checked with HPLC MS[Pre-washout, baseline and 12 weeks.]

Fasting serum Dipeptidyl Peptidase-IV (DPPIV) activity[Pre-washout, baseline and 12 weeks.]

Short Chain Fatty Acids (SCFA) in faecal samples will be analysed[Baseline and 12 weeks]

Secondary ID(s)

None

Source(s) of Monetary Support

The a2 milk Company

Ethics review

Status: Approved
Approval date: 26/07/2017
Contact:

Curtin Human Research Ethics Committee