An Aotearoa New Zealand Diet for Metabolic Health and Whanau Wellbeing: He Rourou Whai Painga

Not Applicable

Recruiting

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

• Registration Number: ACTRN12622000906752
• Lead Sponsor: niversity of Otago

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-06-24
• Last Update Posted: 15 August 2022

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

Inclusion Criteria: For index individual
•Adults aged 18-70 years
•Metabolic syndrome severity z-score (MetS-Z) >0.35.
•In addition to the index individual, a minimum of one other whanau member in the household agrees to participate; (these additional household members, if they qualify, may also be enrolled as an index individual). Up to 5 whanau are eligible to take part
•Participants and their whanau are planning to live together for the duration of the study
•Access to the internet at home
•Able and willing to attend all site visits
•Is willing to adhere to local health and safety regulations
•For the consumer insights study there needs to be a willingness to be interviewed

Inclusion Criteria: For household/whanau members
•Living in the same household as the index individual
•Consent/assent to consume the intervention diet
All household/whanau members who qualify for inclusion will: a) complete age-appropriate questionnaires; b) be invited to undertake clinical measurements; and c) be invited to provide blood samples if aged 11 years and over.

Exclusion Criteria

For index individual
•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 greater than or equal to 50 mmol/mol that are at least three months apart
•Total cholesterol greater than or equal to 8 mmol/L
•Chronic severe renal disease (eGFR less than 30 mL/min/1.72m2)
•Current pregnancy or breastfeeding, or planning to conceive during the study (due to impact on interpreting outcome measures)
•Unstable body weight (active weight loss/gain greater than 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).
•Severe food allergies (anaphylaxis) or intolerances in any household member
•Medication use – current use of medications that modify blood sugar levels, or anticipated regular use of oral or injected steroids
•Does not agree to refrain from donating blood for three months prior to each study visit (due to impact on HbA1c)
•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.

Exclusion criteria for provision of blood samples: For household/whanau members
•Age less than 11 years
•Pre-existing Type 1 diabetes.
•Chronic severe renal disease (eGFR less than 30 mL/min/1.72m2)
•Current pregnancy or breastfeeding, or planning to conceive during the study (due to impact on interpreting outcome measures)
•Unstable body weight (active weight loss/gain greater than 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).
•Medication use – current use of medications that modify blood sugar levels, or anticipated regular use of oral or injected steroids
•Does not agree to refrain from donating blood for three months prior to each study visit (due to impact on HbA1c)
•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
•Children living in the household but who do not have a legal guardian also living in the household
•Severe food allergies (anaphylaxis) or intolerances in any household member

Study & Design

• Study Type: Interventional
• Study Design: Not specified