Effects of a Personalized Functional Food Diet on Cardiometabolic, Microbiome and Metabolomics Profiles in Minority Young Adults
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 112
- 试验地点
- 1
- 主要终点
- Change in stool microbiome profiles
研究概览
简要总结
The proposed study has two primary objectives i.e. to examine how improvements in diet quality via a personalized dietary intervention 1) benefit cardiometabolic outcomes in young Black adults differentially compared to non-Hispanic White adults, and 2) improve carbohydrate and lipid metabolism in relation to the gut microbiome.
详细描述
The study is an 8-wk randomized, controlled, parallel arm clinical trial in which participants (age: 18-35 years, BMI: 25-45 kg/m2, race/ethnicity: Black or White) will be block randomized to a personalized dietary intervention or to receive conventional dietary advice. Outcomes assessed will include metabolites involved in carbohydrate and lipid regulation, gut microbiome composition, and cardiometabolic biomarkers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age: 18-35 years of age
- •BMI: 25-45 kg/m2
- •Black including those of Hispanic ethnicity, and Non-Hispanic White individuals
- •Willingness to consume nuts, fruits and vegetables
- •Willing to comply with study protocol
- •Consistent diet and activity patterns for 4 weeks
- •Weight stable (≤5 kg change over the last 3 months) (Self-reported)
- •Non-smoker >1 year or more
排除标准
- •Allergies to fruits, vegetables, and nuts provided in the study
- •Illicit drug use
- •Recent start of medications that affect metabolism or appetite
- •Antibiotics
- •Coronary artery disease, peripheral artery disease, congestive heart failure, or dyslipidemia requiring drug therapy
- •Uncontrolled hypertension and blood pressure ≥ 180/110 Diabetes
- •Gastrointestinal disease and/or bariatric surgery
- •HIV positivity
- •Pregnant or lactating individuals
研究组 & 干预措施
Personalized diet - Black adults
Young Black adults in this group will receive tailored nutrition counseling from a dietitian. To facilitate meeting their dietary goals, participants will be provided with nuts, fruits, and vegetables.
干预措施: Personalized diet (Other)
Personalized diet - White adults
Young White adults in this group will receive tailored nutrition counseling from a dietitian. To facilitate meeting their dietary goals, participants will be provided with nuts, fruits, and vegetables.
干预措施: Personalized diet (Other)
Conventional dietary advice- Black adults
Young Black adults will receive non-personalized, conventional dietary advice based on the MyPlate guidelines.
干预措施: Conventional dietary advice (Other)
Conventional dietary advice- White adults
Young White adults will receive non-personalized, conventional dietary advice based on the MyPlate guidelines.
干预措施: Conventional dietary advice (Other)
结局指标
主要结局
Change in stool microbiome profiles
时间窗: Change over 8 weeks
16s rRNA sequencing
Matsuda index
时间窗: Change over 8 weeks
Assessed via a 2-hour oral glucose tolerance test
Change in inflammatory markers
时间窗: Change over 8 weeks
MCP-1,IL6, IL10, TNFa, hs-CRP, and fibrinogen
Change in diet quality
时间窗: Change over 8 weeks
Healthy eating index score
Change in glucoregulation
时间窗: Change over 8 weeks
Fasting glucose concentrations
Change in relative intensities of metabolites in blood
时间窗: Change over 8 weeks
Measured by untargeted metabolomics mass spectrometry
Change in endothelial function
时间窗: Change over 8 weeks
Reactive hyperemia index
Change in lipid profile
时间窗: Change over 8 weeks
LDL, HDL, triglycerides, total cholesterol
Change in insulinemic biomarker concentrations
时间窗: Change over 8 weeks
Fasting insulin and C-peptide concentrations
Change in blood pressure
时间窗: Change over 8 weeks
Diastolic and systolic blood pressure
次要结局
- Physical activity(Every 4 weeks over the 8 week intervention)
- Palatability rating of foods(Every 2 weeks over the 8 week intervention)
- Body Composition(Every 2 weeks over the 8 week intervention)
- Body Mass(Every 2 weeks over the 8 week intervention)
- Anthropometrics(Every 2 weeks over the 8 week intervention)
- 24-hour appetite ratings(Every 4 weeks over the 8 week intervention)
- Acceptance rating of foods(Every 2 weeks over the 8 week intervention)
研究者
Jaapna Dhillon
Assistant Professor, Nutrition & Exercise Phys-MED
University of Missouri-Columbia