westlake n-of-1 trials for macronutrient intake 2 ( we-macnutr 2)

Conditions: Postprandial Hyperglycemia; Metabolic Disorder, Glucose

Summary: diet and nutrition are key to maintain human health. westlake n-of-1 trials for macronutrient intake (we-macnutr) trial investigates individualized postprandial glycemic responses to different proportions of dietary fat and carbohydrates intake using an n-of-1 experimental study design. the experimental diets are isocaloric high fat, low carbohydrate (hf-lc) or low fat, high carbohydrate (lf-hc). with standardized intervention and strictly controlled eating behaviors, the we-macnutr study identifies specific hc-responders and hf-responders in terms of postprandial glucose response. this is a follow-up study offered to participants who have completed the we-macnutr study in 2019. volunteers will be asked to participate in four 5-d periods while wearing glucose monitors (abbott freestyle libre) with the following experimental sequence: 1) a washout diet, 2) hf-lc or lc-hf diet, 3) a washout diet, 4) hf-lc or lc-hf diet. the experimental diet will be randomly assigned. participants will be asked to provide a fasted blood sample and to collect fecal, urine and saliva samples at each visits.

this study is a two arm dietary intervention study. participants will be recruited from the we-macnutr study based on the defined inclusion and exclusion criteria. the study duration will last up to 21 days. volunteers will be asked to participate in four 5-day periods while wearing glucose monitors (abbott freestyle libre) with the following experimental sequence: 1) a washout diet, 2) hf-lc or lc-hf diet, 3) a washout diet, 4) hf-lc or lc-hf diet. the experimental diet will be randomly assigned. participants will enter the study on a usual (washout) diet and will have a 5-day run in period for baseline data collection. participants will be asked to follow dietary guidance and consumed a healthy and balanced diet during this period.

Eligibility criteria:
inclusion criteria: * participants have completed we-macnutr trial in 2019 * participants have no traveling plans within 1 months * participants are able and willing to comply with the study protocol and provide informed consent exclusion criteria: * refuse or are unable to provide informed consent to participate in the study * have long-term gastrointestinal diseases and take daily relevant medications * have taken antibiotics in the last 2 weeks * have type 2 diabetes and are taking medications or other treatments * have chronic or acute liver disease and are taking medications or other treatments * have cardiovascular diseases and are taking medications or other treatments * have kidney disease and are taking medications * suffer from chronic anxiety or depression, or other critical neuronal disorder and/or history of relevant medication * are pregnant or lactating, or are planning to be pregnant in the next 3 months * diagnosed with an eating disorder (e.g. anorexia nervosa or bulimia nervosa) * are vegan, or unwilling to consume foods provided in the study * have history of alcohol or drug addiction, or smoke above 15 cigarettes per day

Keywords: personalized nutrition glucose metabolism gut microbiota