A High Quality Aotearoa New Zealand Diet for Metabolic Health and Whanau Wellbeing in Adults with Metabolic Syndrome: Pilot Intervention Study

Capital and Coast District Health Board0 个研究点目标入组 30 人开始时间: 2021年7月2日最近更新: 2021年7月12日

适应症

试验速览

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•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.

•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

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