The Milky Way Study: Comparing effects of regular fat vs reduced fat dairy products on heart and gut health in young childre

Not Applicable

Completed

• Conditions: adiposity; gut health and microbiome; cardiometabolic health; Diet and Nutrition - Other diet and nutrition disorders; Diet and Nutrition - Obesity; Cardiovascular - Normal development and function of the cardiovascular system

• Registration Number: ACTRN12616001642471
• Lead Sponsor: Edith Cowan University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-11-28
• Last Update Posted: 3 February 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 55

Inclusion Criteria

1. Boys and girls aged four to six, inclusive, at beginning of study
2. Consume at least one serve of dairy per day (e.g. 40g cheese, 250 ml milk, 200g yoghurt)
3. Have more than 70% (5 of 7 days) of their dairy either consumed at home or prepared at home
4. Willing to complete three x 3-day food records
5. Willing to provide blood (twice) and stool samples (three times)
6. Willing to attend three clinical visits at Joondalup ECU
7. Not participating in any other studies which may influence the outcome variables of this study
8. If probiotics are being taken, stable probiotic use over the duration of study (defined as keeping the same intake amount and type of probiotic over the study period between baseline and final assessments).

Exclusion Criteria

Children will be ineligible to participate if they:
1. Are lactose intolerant
2. Are allergic to cow’s milk protein e.g. dairy products
3. Have taken antibiotics within the last six months (may be reduced to three months depending on ease of recruitment)
4. Have any digestive disorder which may affect nutrient absorption and gastrointestinal motility such as Coeliac disease, Irritable Bowel Disease/Disorder, ulcerative colitis or Crohn’s Disease
5. Have a history of regular intestinal discomfort (e.g. diarrhoea, constipation once a week or more frequently);
6. Have had any surgery involving the gastro-intestinal tract
7. Have diabetes or diagnosed metabolic syndrome
8. Are taking any medication that will significantly alter the measurements of the primary outcome variables, including anti-hypertensives or lipid-lowering medications
9. Have or have had any cardiovascular events or diagnosed cardiovascular disease or metabolic disease
10. Have a body weight lower than 9.5 kg.

Study & Design

• Study Type: Interventional
• Study Design: Not specified