None listed
Conditions
Brief summary
The High Value Nutrition (HVN) National Science Challenge works with scientists and businesses to add nutritional value to fresh and processed food products for the benefit of consumers whether in New Zealand or elsewhere in the world. Funded by HVN, the investigators are leading the development and implementation of He Rourou Whai Painga, a long-term multi-centre dietary intervention study that will explore whether consumption of high quality New Zealand F&B products in an adapted Mediterranean-style dietary pattern improves metabolic, cardiovascular, and wellbeing profiles in people at risk of cardiometabolic disease. The current proposal describes a pilot study that will be used to finalise the study design, power calculations, and final methodology of the main intervention study, He Rourou Whai Painga.
Interventions
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 r
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.
Sponsors
Capital and Coast District Health Board
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Prevention
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Healthy volunteers
No
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
Outcome results
None listed