The Healthy NZ Foods Pilot Study for Adults with Metabolic Syndrome

Not Applicable

• Conditions: Obesity; Metabolic and Endocrine - Metabolic disorders; Metabolic Syndrome; Diet and Nutrition - Obesity

• Registration Number: ACTRN12621000856819
• Lead Sponsor: Capital and Coast District Health Board

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-07-02
• Last Update Posted: 12 July 2021

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Measures

Name	Time	Method
Recruitment Rates assessed by audit of study database[12 weeks post intervention];Anthropometric measures including waist circumference (tape measure), weight (standing tanita scales), height (stadiometer) and body mass index (BMI) <br>[12 weeks post intervention];Adherence to Mediterranean diet using 24hr recall [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]