Pilot Investigation of the Ketogenic Diet's Health Effects Through Multi-Omics Assessment
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Changes in Advanced Lipid Panel
研究概览
简要总结
The goal of this pilot intervention is to learn about how a well-formulated ketogenic diet (WFKD) impacts various health factors in generally healthy adults. The main questions it aims to answer are:
- Establish whether an 8-week isocaloric, WFKD improves body composition and metabolic biomarkers in adults without chronic disease.
- Examine changes in transcriptomic sequencing pathways pre- and post-WFKD intervention.
- Explore gut microbial changes in adults without chronic disease that consume a WFKD.
Participants will follow a well-formulated ketogenic diet for 8-weeks. Study procedures include:
- Weekly body weight tracking
- Daily urinary ketone assessment
- Pre/post stool samples for gut microbiota analyses
- Pre/post DXA scans
- Diet quality tracking through 3-day food records
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •30 to 55 years
- •Speaks English as primary language
- •BMI 20.0-34.9 kg/m^2
排除标准
- •Certain medications (statin, blood pressure, thyroid hormone replacement, etc.)
- •Prior medical diagnosis of type 1 or type 2 diabetes mellitus, cancer requiring chemotherapy or radiation therapy within 5 years, cardiac event, GI disorders, traumatic brain injury/multiple concussions, hypertension, dyslipidemia, or any diagnosis deemed ineligible by study team
- •History of renal stones
- •Currently lactating
- •Already following a ketogenic diet
- •Adherence to a specialized diet regimen that disallows compliance
- •Use of tobacco or tobacco replacement products within 1 year
结局指标
主要结局
Changes in Advanced Lipid Panel
时间窗: Baseline, 8 Week
Changes in Body Composition-- dual x-ray absorptiometry (DXA)
时间窗: Baseline, 8 Week
Measures of tissue distribution
Changes in Waist Circumference (WC)
时间窗: Baseline, 4 Week, 8 Week
Waist circumference (cm)
Changes in Body Mass Index (BMI)
时间窗: Baseline, 4 Week, 8 Week
Ratio of height and weight in kg/m\^2
Changes in Homeostatic model assessment of Insulin Resistance (HOMA-IR)
时间窗: Baseline, 4 Week, 8 Week
Ratio of fasting glucose and fasting insulin with a conversion factor, unitless
Changes in Inflammation
时间窗: Baseline, 8 Week
Changes in high sensitivity C-reactive protein (hs-CRP) (mg/L)
次要结局
- Changes in transcriptomic sequencing pathways(Baseline, 8 weeks)
- Gut microbial changes(Baseline, 8 weeks)
研究者
Debra K. Sullivan, PhD, RD
Department Chair, Dietetics and Nutrition
University of Kansas Medical Center