Abstract
Objectives
The study will investigate the effectiveness of an Asian food based intervention to improve metabolic health, notably glucose homeostasis in a prediabetic population.
Methods
A parallel design randomized controlled trial will be conducted in Chinese prediabetics aged 45–75 years, BMI 19.5–32 kg/m2. Prediabetes defined according to the American Diabetes Association guideline: fasting blood glucose 5.6–6.9 mmol/l or hemoglobin A1c 5.7–6.4% or 2-hr oral glucose tolerance test 7.8–11.0 mmol/l. Major exclusion criteria were: smoking, food allergies or intolerances to common food ingredients, dietary restrictions, sustained hypertension (>160/95 mmHg), history of metabolic, cardiac, liver or kidney disorders, thyroid dysfunction and recent weight loss. The dietary intervention will last for 16 weeks, where volunteers will consume 2 specially formulated main meals per day, provided as pre-cooked, frozen, ready-meals (approximately 400 kcal each). The treatment group (TG) meals will be prepared with legumes, low GI rice or noodles, blended vegetable oil and added mixed herbs and spices. The control group (CG) meals, isocaloric, will consist of a portion of chicken, a portion of vegetables, medium to high GI rice or noodles and negligible herbs and spices. The male volunteers will be provided additional 100 kcal snacks containing either wholegrain cereals and nuts/seeds (TG) or refined cereal snack products (CG). The daily meals and snacks for rest of the day will be chosen freely, while a dietitian limits the total average calorie consumption to ensure around 5% weight loss in both groups. The effects of dietary interventions on metabolic health will be assessed at every 4 week intervals. The primary outcome measures will include several markers of glucose homeostasis (including HbA1c, fasting glucose, fasting insulin and a 2-hr oral glucose tolerance test [OGTT]). The secondary outcomes will include lipid profile, fructosamine, adiponectin, markers of oxidative stress and chronic inflammation.
Results
The recruitment for the study has been completed (n = 256 screened, n = 123 suitable). The dietary intervention will commence in March 2021 and expected to be completed in July 2021.
Conclusions
N/A.
Funding Sources
Jointly funded by the National University of Singapore, Agency of Science Technology and Research, Singapore, and Wilmar International Limited.
Weight loss and metabolic health effects from energy-restricted Mediterranean and Central-European diets in postmenopausal women: A randomized controlled trial
