None listed
Conditions
Brief summary
This project is funded by NZ National Science Challenge, High Value Nutrition(HVN)program. HVN investigates metabolic health in Asian populations, with main focus on Asian Chinese. Objectives: The objective of this study is to improve metabolic health, including glycaemic control, in a cohort of overweight prediabetic Asian Chinese adults, randomised to 3 month meal or snack replacement intervention with a high protein, high (good) fat product or an energy equivalent lower protein, low fat product. Methods: A total of 112 Asian Chinese participants who are overweight and have prediabetes, as defined by impaired fasting glucose (IFG), will be recruited at 2 study sites from the wider Auckland and Wellington regions. Eligible participants will be randomized either to a) higher protein/ high fat (good fat) bar or b) lower protein/ low fat bar, The bars are matched for energy content. Participants will be instructed to consume their food prescription (1 bar/day) for 5 days/wk as a meal or snack replacement, not as a dietary addition. Participants will attend 5 clinical investigation days (CIDs) at baseline (week 0), and weeks 2, 4, 8, and 12 of the study. The primary outcomes will be fasting plasma glucose both; acutely (2h post meal) and over the 12 week period. Secondary outcomes will be body composition (fat distribution); fasting insulin; homeostatic model of insulin resistance (HOMA-IR; glycated haemoglobin (HbA1c); 2h glucose and insulin during an oral glucose tolerance test (OGTT) and metabolomics profile. Other outcomes will include microbiome community, energy and macronutrient intake, body weight and body mass index (BMI), lipid profile, appetite hormones (GLP-1, PYY, CCK) and markers of inflammation (C reactive protein - CRP -, TNF-alpha and IL-6).
Interventions
This will be a 2arm randomised controlled trial of parallel design. A total of 112 Asian Chinese participants who are overweight and have prediabetes will be recruited from the wider Auckland and Wellington regions from March 2018. Eligible participants will be stratified by sex, age and BMI, and randomized either to a) a higher protein/ higher fat (good fat) bar or b) a lower protein, lower fat bar and matched for energy content. Participants will be instructed to consume their food prescriptio
This will be a 2arm randomised controlled trial of parallel design. A total of 112 Asian Chinese participants who are overweight and have prediabetes will be recruited from the wider Auckland and Wellington regions from March 2018. Eligible participants will be stratified by sex, age and BMI, and randomized either to a) a higher protein/ higher fat (good fat) bar or b) a lower protein, lower fat bar and matched for energy content. Participants will be instructed to consume their food prescription (1 bar/day) for 5 days/wk for 3 months as a meal or snack replacement, not as a dietary addition. The bars will be matched for energy (approx. 1000 kJ). The test bar will have approx. 6.4%En protein, 66.3%En fat (only 3.8%En saturated fat) and 29%En carbohydrate; the control bar will have approx. 4.6%En protein, 26.7En% fat (only 2.2%En saturated fat) and 64.4%En carbohydrate. Both groups will receive healthy eating advice at weeks 0 (60min duration) and weeks 2, 4, 8, 12 (30min duration each), based on the China Medical Nutrition Therapy Guideline for Diabetes (2013) (Chinese Diabetes Society 2015) recommendations. Participants will attend a screening visit at week -1 and 5 clinical investigation days (CIDs) at the Human Nutrition Unit in Auckland or Centre for Endocrine, Diabetes and Obesity Research (CEDOR) in Wellington, at baseline (week 0), and weeks 2, 4, 8, and 12 of the study. During CIDs, anthropometric data, biological samples and subjective data (questionnaires) will be collected to access the impact of the diets on metabolic health. Adherence will be assessed through the completion of 4-day food records, the number of packages returned from the trial bars and through assessment of specific lipids in blood samples, collected from participants during the visits. At each CID (week 0, 2, 4, 8 and 12) participants will have a 60min (week o) or 30min (weeks 2, 4, 8 and 12) healthy eating session with the dietitian. Postprandial glycaemic responses of the bars and the bars + a typical carbohydrate rich food (white bread) will be analysed acutely at the Auckland Centre only.
Sponsors
University of Auckland - Research Office
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
25 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
a) male or female b) Asian (Ethnic Chinese, incl. mainland China, Singapore, Malaysian, Hong Kong, Taiwan, plus Korea);both parents ethnicity confirmed c) aged between 25 and 70 years; d) BMI between 24-40kg/m2 (Asian) e) FINDRISC equal or greater than 15 (optimal cut-off for higher efficiency and efficacy of recruitment (Silvestre, Jiang et al. 2017) f) fasting plasma glucose between 5.6 and 6.9mmol/l (ADA) g) healthy otherwise;
Exclusion criteria
a) BMI <24 kg/m2 or BMI>40kg/m2; b) recent body weight loss/gain >5%, within previous 3 months; c) type 1 or type 2 diabetes d) significant CVD including current angina; myocardial infarction or stroke within past 6 months; heart failure; symptomatic peripheral vascular disease; SBP >160 mmHg and/or DBP >100 mmHg (with or without hypertensive medication) e) major food allergy (e.g. allergy to nuts)
Outcome results
None listed