None listed
Conditions
Brief summary
Prevention of type 2 diabetes (T2D) is a key global health target, with change in diet being a first line strategy. Yet the optimum composition of the diet for long term prevention, to enhance outcomes that can be achieved through weight loss, remains under considerable debate. Additionally, response to dietary intervention, in particular the postprandial glucose response (PPGR), remains poorly characterised in those at risk of diabetes. Predicting response, and in turn personalising intervention diets to optimise glycaemic improvements in high risk individuals is an important step in understanding how diet may help to ameliorate dysglycaemia and T2D.. The proposed FERDINAND Study is a longer-term 8 month intervention in a larger multi-ethnic cohort of ‘at risk’ adults; with the aim of evaluating a F&B product that may contribute to improved glycaemia during both weight/adipose mass loss and longer-term weight loss maintenance. Plant-derived polyphenols, commonly found in fruits such as feijoa, may provide a novel nutrition approach with evidence from prior pre-clinical, and a human clinical study, demonstrating improvement in glycaemic parameters following short-term consumption of commercially available whole feijoa powder. Use of machine-learning algorithms will integrate clinical responses and ‘omics outputs to predict individual response to the intervention. The outcomes of PPGR from the FERDINAND Cohort will be important as it will provide predictive algorithms that can be validated in future follow-up assessments.
Interventions
The FERDINAND study is a 2 arm, parallel design, double blind randomised control trial conducted in 160 participants (n=80 per intervention group). The dietary intervention will span 6 months, consisting of an initial acute 2-month weight-loss phase driven by low energy diet (LED; Phase 1) and followed by a longer-term 4-month weight loss maintenance phase (Phase 2) using dietary advice which adheres to the NZ Ministry of Health Guidelines.
The 2 intervention arms are as follows:
1. Healthy diet
The FERDINAND study is a 2 arm, parallel design, double blind randomised control trial conducted in 160 participants (n=80 per intervention group). The dietary intervention will span 6 months, consisting of an initial acute 2-month weight-loss phase driven by low energy diet (LED; Phase 1) and followed by a longer-term 4-month weight loss maintenance phase (Phase 2) using dietary advice which adheres to the NZ Ministry of Health Guidelines. The 2 intervention arms are as follows: 1. Healthy diet/weight loss advice + feijoa whole fruit powder (n=80) Total meal replacement during the LED phase only [e.g. clinical investigation day (CID) 1 - CID 2], 4MJ/day; 1150 mg/d feijoa whole fruit powder daily in both phase 1 and phase 2 (to be consumed daily, with breakfast meal) 2. Healthy diet/weight loss advice + matched Placebo (n=80) Total meal replacement during the LED phase only [CID 1- CID 2], 4MJ/day; 1150 mg/d matched placebo (e.g. bland non active commercial placebo like microcrystalline cellulose) daily in both phase 1 and phase 2 (to be consumed daily, with breakfast meal). Participants will be randomised to either of the two study arms, and will be required to adhere to the dietary advice provided by research staff/dietitians. They will be provided with all LED (as Cambridge Weight Plan sachets) + powder during the first 2 mths of the study. LED is energy restricted with a target intake of ~4MJ/day. The target macronutrient composition of the diet will be 15-20% of total energy from fat, 35-40% from protein and 45-50% from carbohydrate. LED products include shakes, soups, bars, porridge, pasta and savoury meals. Participants will be supported throughout the first two months of the LED phase, either in person or via virtual online mHealth platform, at 5 group meetings delivered from the HNU clinic site. All LED sachets will be provided free of charge to the participants. During the subsequent 4 month weight maintenance phase 2 of the study, they continue to receive the powder and will additionally receive dietary advice following best practice New Zealand Ministry of Health healthy eating guidelines for improving metabolic health, with diet advice provided by dietitians. These meetings will be either in person or via virtual mHealth platform; at 4 group meetings delivered from the research site. There will be a total of 9 clinic visits and group diet advice (which will be a combination of in person or via virtual mHealth platform conducted by dietitians throughout the intervention, to provide dietary advice and support to maximise compliance and treatment success). Group diet advice sessions (~1-2 hours) are as follows: In person visits: week: 0, 8 (Phase 1, LED); and month 4, 6 (Phase 2, maintenance). Virtual visits: week 2,4,6 (Phase 1, LED) and month 3,5 (Phase 2, maintenance). Within each diet intervention arm, a sub group of participants will be randomised to undergo further additional repeated assessments (i.e. magnetic resonance imaging and spectroscopy, oral glucose tolerance test and indirect calorimetry) at CID 1 and follow up CID 2, and CID 4. Compliance will be monitored over the intervention period from nitrogen balance, based on 24-hr urine collection.
Sponsors
The university of Auckland
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
• Male and female • Aged between 18 - 70 years • BMI greater than or equal to 26 kg/m2 and body weight less than or equal to 150kg • Fasting plasma glucose (FPG) in prediabetic range, 5.6 – 6.9 mmol/L • Otherwise healthy, as per self-report • Agreement to participate in a weight loss study
Exclusion criteria
• Type 1 or type 2 diabetes mellitus • Medications controlling glycaemia • Current or history of significant disease including cardiovascular disease; pancreatic disease, or other digestive diseases including inflammatory bowel syndrome/disease, ulcerative colitis, Crohn's disease; cancer; plus associated medications including steroids (except topical steroids) and atypical antipsychotics • Recent body weight loss/gain > 10 % within previous 3 months or taking part in an active diet program; or current medications for weight loss; or intending to alter physical activity during following 12 months • Previous bariatric surgery • Smoker or vaper, current or in previous 6 months • Recreational drug user, current or in previous 6 months • Pregnant or breastfeeding women, current or in previous 6 months • Dislike or unwilling to consume food items included in the study (including animal products), or hypersensitivities or allergies to these foods • Unwilling/unable to comply with study protocol • Participation in other clinical intervention study, current or in previous 6 months • Considered unsuitable to participate by the PI
Outcome results
None listed