Clinical trial NCT04125602: Westlake N-of-1 Trials for Macronutrient Intake
Official title: Westlake Personalized Nutrition Intervention Study: N-of-1 Trials for Dietary Macronutrient Intake
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postprandial Hyperglycemia
Metabolic Disorder, Glucose
Keywords: Personalized Nutrition
Glucose Metabolism
Gut Microbiota
Lead sponsor: Westlake University
Sponsor class: OTHER
First posted: 2019-10-14
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: This is a dietary intervention study in students and staff of Westlake University, which is designed to provide evidence in support of N-of-1 methods as an approach to advance personalized nutrition. The primary aim is using a series of N-of-1 trials to determine the impacts of a high fat, low carbohydrate diet (HF-LC) on glucose metabolism and gut microbiota in subjects versus a low fat, high carbohydrate diet (LF-HC) at both the individual and group level.

Detailed description: This study will employ a series of individual N-of-1 trials comparing a high fat, low carbohydrate diet (HF-LC) to a low fat, high carbohydrate diet (LF-HC). Participants will enter the study on a usual diet and will have a 6-day run in period for diet planning and baseline data collection before beginning their intervention. The HF-LC or the LF-HC will be randomized as the starting intervention followed by a wash-out period lasting for 6 days with normal diet between two interventions to eliminate previous intervention effects. Then the participants will be provided with the other diet. Both HF-LC and LF-HC last for 6 days in each set which consists of two wash-out periods and two intervention periods. There will be 3 sets in this study and investigators will aggregate the results of the completed N-of-1 trials across all participants to estimate the group level impacts of HF-LC compared to LF-HC.

Eligibility criteria: Inclusion Criteria:

* Willingness and capability to complete the study protocol

Exclusion Criteria:

* Inability or unwillingness to approved to provide informed consent
* Neurological conditions that might affect the assessment of the study measurement
* Hospitalization or surgery planned within 3 months
* Gastrointestinal diseases
* Other serious medical conditions, such as liver, kidney, or systemic disease
* Women who are pregnant or lactating
* Tobacco, alcohol, or illicit drug abuse
* Had taken antibiotics in the past two weeks prior to the start of the trial
* Participants on a vegan diet
* Any food allergy
* Lack of smart phone and data plan for participating caregiver
* Non-Chinese speaking participants
* Participating in another concurrent intervention study

Primary outcomes:
measure: Postprandial blood glucose change
timeFrame: Day 7-12 and day 19-24 of each set
measure: Blood glucose profiling
timeFrame: Day 7-12 and day 19-24 of each set
Secondary outcomes:
Other outcomes:
measure: Fecal metabolites
timeFrame: Day 1, day7, day 13 and day 19 of each set
measure: Fecal microbiota
timeFrame: Day 1, day7, day 13 and day 19 of each set
measure: Metabolomics profiling
timeFrame: Day 1, day7, day 13 and day 19 of each set
measure: Laboratory markers of glucose metabolism and inflammation
timeFrame: Day 1, day7, day 13 and day 19 of set 1
measure: Lipid metabolism
timeFrame: Day 1, day7, day 13 and day 19 of set 1
measure: Physiological characteristics
timeFrame: Day 1, day7, day 13 and day 19 of set 3
Locations:
city: Hangzhou
country: China
facility: Westlake University
state: Zhejiang
Study officials:
affiliation: Westlake University
name: Ju-Sheng Zheng, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Tian Y, Ma Y, Fu Y, Zheng JS. Application of n-of-1 Clinical Trials in Personalized Nutrition Research: A Trial Protocol for Westlake N-of-1 Trials for Macronutrient Intake (WE-MACNUTR). Curr Dev Nutr. 2020 Aug 26;4(9):nzaa143. doi: 10.1093/cdn/nzaa143. eCollection 2020 Sep.