The Healthy NZ Foods Pilot Study for Adults with Metabolic Syndrome

• Register: ANZCTR
• Last refreshed on: 12 July 2021
• Main ID: ACTRN12621000856819
• Date of registration: 02/07/2021
• Prospective Registration: Yes
• Primary sponsor: Capital and Coast District Health Board
• Public title: The Healthy NZ Foods Pilot Study for Adults with Metabolic Syndrome
• Scientific title: A High Quality Aotearoa New Zealand Diet for Metabolic Health and Whanau Wellbeing in Adults with Metabolic Syndrome: Pilot Intervention Study
• Date of first enrolment: 02/08/2021
• Target sample size: 30
• Recruitment status: Not yet recruiting
• URL: https://anzctr.org.au/ACTRN12621000856819.aspx
• Study type: Interventional
• Study design: Purpose: Prevention; Allocation: Non-randomised trial; Masking: Open (masking not used);Assignment: Single group;
• Phase: Not Applicable

Countries of recruitment

New Zealand

Contacts

• Name: Mrs Amber Parry Strong

• Name: Mrs Amber Parry Strong

Key inclusion & exclusion criteria

Inclusion criteria: • Adults aged 18-70 years
• Metabolic syndrome severity z-score (MetS-Z) >3.5.
• In addition to the index individual, the other members of their household/wha¯nau will be invited to participate in the research. If household/wha¯nau members that take part meet the inclusion/exclusion criteria they will be included in primary outcome, if not data will be collected for secondary analysis.

Exclusion criteria: • Previous bariatric surgery, or pre-existing Type 1, or Type 2 diabetes. Where a previous diagnosis of T2DM is uncertain, this will be defined as ever having had two consecutive HbA1c results > or = 50 mmol/mol that are at least three months apart
• Chronic renal disease (eGFR <30 mL/min/1.72m2)
• Serious immune dysfunction (for example HIV/AIDS, immune deficiency diseases)
• Current pregnancy or breastfeeding, or planning to conceive during the study
• Unstable body weight (active weight loss/gain > 5 kg in prior three months)
• Gastrointestinal disorder that alters the digestion and absorption of nutrients (E.g. ulcerative colitis, Crohn’s disease, coeliac disease, an ileostomy or colostomy).
• Food Allergies (anaphylaxis)
• Medication use – current use of immune suppressant medications, medications that modify blood sugar levels, or anticipated regular use of such medications (e.g. frequent use of oral or injected steroids), long-term use of systemic antibiotics
• Does not agree to refrain from donating blood for three months prior to each study visit
• Is participating in, or has recently participated in another research study involving an intervention which may alter outcomes of interest to this study
• Any other condition or situation, which in the view of investigators would affect the compliance or safety of the individual taking part


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

Health Condition(s) or Problem(s) studied

Diet and Nutrition - Obesity

Metabolic and Endocrine - Metabolic disorders

Obesity;Metabolic Syndrome;
Obesity
Metabolic Syndrome

Intervention(s)

All participants will receive foods consistent with the Mediterranean diet, 50-75% of their daily intake. Participants will receive food delivered to their home each week by My Food Bag delivery company. This will consist of 5 main meals (participants can choose from the weekly healthy heart options) and extra food for lunches and breakfast including fish, cereals, fruit, vegetables, oil and bread. This food will be delivered weekly for 12 weeks. Participants are not given advice regarding the remaining two main meals each week. Participants will be asked to report each week how much they consumed and of what, using the online form at the time they order their next weeks meals.

Primary Outcome(s)

The primary outcome is the Metabolic Severity Z-Score at 12 weeks post intervention. The Metabolic Severity Z-Score is calculated using blood pressure assessed using manual sphygmomanometer, fasting blood glucose and fasting lipids from blood test and waist circumference measured in cm by measuring tape. [12 weeks post intervention]

Secondary Outcome(s)

Adherence to Mediterranean diet using 24hr recall [12 weeks post intervention]

Anthropometric measures including waist circumference (tape measure), weight (standing tanita scales), height (stadiometer) and body mass index (BMI)
[12 weeks post intervention]

Kaupapa Ma¯ori Wellbeing questionnaire for participants seen at Kokiri Marae provided by The Centre for Health Tauranga and designed by Anna Rolleston. [12 weeks post intervention]

Recruitment Rates assessed by audit of study database[12 weeks post intervention]

Secondary ID(s)

None

Source(s) of Monetary Support

National Science Challenge High Value Nutrition

Ethics review

Status: Not approved
Approval date:
Contact:

NZ HDEC