Metabolic syndrome Nutritional, Metabolic, Endocrine
Conditions
Interventions
This is a randomised controlled trial of food provision and dietary change support (Group A) compared with a self-selected habitual dietary intake (Group B) for 12 weeks.
Randomisation will be via a
Sponsors
University of Otago
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: For index individuals: 1. Adults aged 18-70 years 2. Metabolic syndrome severity z-score (MetS-Z) >0.35 3. 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 five whanau are eligible to take part 4. Participants and their whanau are planning to live together for the duration of the study 5. Access to the internet at home 6. Able and willing to attend all site visits 7. Is willing to adhere to local health and safety regulations 8. For the consumer insights study there needs to be a willingness to be interviewed For household/whanau members: 1. Living in the same household as the index individual 2. 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
Exclusion criteria: For index individuals: 1. Previous bariatric surgery, or pre-existing Type 1, or Type 2 diabetes. Where a previous diagnosis of type 2 diabetes mellitus (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 3 months apart 2. Total cholesterol greater than or equal to 8 mmol/l 3. Chronic severe renal disease (eGFR 5 kg in the prior 3 months) 6. Gastrointestinal disorder that alters the digestion and absorption of nutrients (e.g. ulcerative colitis, Crohn’s disease, coeliac disease, an ileostomy or colostomy) 7. Severe food allergies (anaphylaxis) or intolerances in any household member 8. Medication use – current use of medications that modify blood sugar levels, or anticipated regular use of oral or injected steroids 9. Does not agree to refrain from donating blood for three months prior to each study visit (due to impact on HbA1c) 10. Is participating in, or has recently participated in another research study involving an intervention which may alter outcomes of interest to this study 11. Any other condition or situation, which in the view of investigators would affect the compliance or safety of the individual taking part For household/whanau members (blood samples): 1. Age 5 kg in prior 3 months) 6. Gastrointestinal disorder that alters the digestion and absorption of nutrients (e.g. ulcerative colitis, Crohn’s disease, coeliac disease, an ileostomy or colostomy) 7. Medication use – current use of medications that modify blood sugar levels, or anticipated regular use of oral or injected steroids 8. Does not agree to refrain from donating blood for three months prior to each study visit (due to impact on HbA1c) 9. Is participating in, or has recently participated in another research study involving an intervention which may alter outcomes of interest to this study 10. Any other condition or situation, which in the view of investigators would affect the compliance or safety of the individual taking part 11. Children living in the household but who do not have a legal guardian also living in the household 12. Severe food allergies (anaphylaxis) or intolerances in any household member
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Metabolic syndrome severity z-Score (MetS-z) measured using a fasted blood sample (for glucose and lipids), blood pressure and waist circumference at 12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Weight measured using a weighing scales at 12 weeks 2. Body composition (body mass index [BMI], fat mass and lean mass) measured using a DXA scan, weighing scales and a stadiometer at 12 weeks 3. Dietary pattern among index participants measured using dietary pattern analyses at 12 weeks 4. Change from baseline in metabolic syndrome severity z-score (MetS-z) in full cohort measured using a fasted blood sample (for glucose and lipids), blood pressure and waist circumference at 24 and 52 weeks 5. Individual components of MetS z score measured using a fasted blood sample (for glucose and lipids), waist circumference and blood pressure at 12 weeks 6. Change in individual components of the MetS z score (fasting glucose, waist circumference, blood pressure, lipid profile) in full cohort at 24 weeks 7. Change in individual components of the MetS z score (fasting glucose, waist circumference, blood pressure, lipid profile) in full cohort at 52 weeks 8. Dietary pattern after secondary randomisation to continued support vs no ongoing support measured using dietary pattern analyses from 12 weeks to 24 weeks (added 24/06/2022): Qualitative component outcome measures, measured using NVivo software to assist with a thematic analysis using open and axial coding after the end of the intervention: 1. Participants' reported on their understanding of what a healthy way of eating is. 2. Participants' reported on the application of the ‘tools’ they are learning from the programme to assist them in adopting this healthy eating programme. 3. Participants' reported on any empowerment in their ability to follow this new way of healthy eating. 4. Participants reported on their ability to encourage their family to follow this new way of healthy eating. 5. Participants reported their feelings of wellbeing. 6. Participants reported on their ability to follow this new way of healthy eating. 7. Participants reported their intentions regarding following this new way of healthy eating. | — |
Countries
New Zealand
Outcome results
None listed