The Ketogenic Diet, Blood Lipids, and Heart Health in Healthy Adults With Differing BMI
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- LDL-cholesterol concentration change from baseline
研究概览
简要总结
The goal of this clinical trial is to examine the effect of the ketogenic diet over four weeks on blood lipid levels and risk factors for heart disease in adults with a healthy BMI compared to adults with a body mass index (BMI) in the range for obesity. The main questions it aims to answer are:
- Does the ketogenic diet cause larger increases in "bad cholesterol" (low density lipoprotein-cholesterol) in adults with a healthy BMI compared to adults with BMI in the range for obesity?
- Does the ketogenic diet cause larger decreases in vascular health in adults with a healthy BMI compared to adults with BMI in the range for obesity?
Participants will:
- Consume all of the study food provided and avoid intake of non-study foods during the 28-day diet period
- Visit the metabolic kitchen daily (Monday-Friday) to pick up meals
- Attend 5 fasting visits at the Clinical Research Center for testing
详细描述
This is a controlled feeding study investigating if four weeks on the ketogenic diet will cause differential alterations in blood lipids and lipoproteins, vascular health as measured by fasting flow mediated dilation (FMD), and mechanistic markers of lipid metabolism in adults with normal weight when compared to adults with obesity. Outcomes will be measured at both the beginning and end of the study on two consecutive days, for a total of four clinic appointments.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 25 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 25-45 years
- •Fasting direct LDL-C ≤100 mg/dL
- •BMI of 18.5-22 kg/m2 or 30-35 kg/m2
- •Blood pressure <140/90 mmHg
- •Fasting blood glucose <126 mg/dL
- •Fasting triglycerides <350 mg/dL
- •≤10% change in body weight for 6 months prior to enrollment
排除标准
- •Have type 1 or type 2 diabetes or fasting blood glucose ≥126 mg/dL
- •Prescription of anti-hypertensive, lipid-lowering or glucose-lowering drugs
- •Intake of supplements that affect the outcomes of interest and unwilling to cease during the study period
- •Diagnosed liver, kidney, or autoimmune disease
- •Prior cardiovascular event (e.g., stroke, heart attack)
- •Current pregnancy or intention of pregnancy within the next 2 months
- •Lactation within prior 6 months
- •Follows a vegetarian or vegan diet
- •Food allergies/intolerance/sensitives/dislikes of foods included in the study menu
- •Antibiotic use within the prior 1 month
- •Oral steroid use within the prior 1 month
- •Use of tobacco or nicotine containing products within the past 6 months
- •Cancer at any site within the past 10 years (eligible if ≥10 years without recurrence) or non-melanoma skin cancer with in the past 5 years (eligible if ≥5 years without recurrence)
- •Participation in another clinical trial within 30 days of baseline
- •Currently following a restricted or weight loss diet
- •Previously consumed the ketogenic diet for more than 1 week
- •Prior bariatric surgery
- •Intake of >14 alcoholic drinks/week and/or lack of willingness to consume no alcohol while enrolled in the study and/or not willing to avoid alcohol consumption for 48 hours prior to test visits
- •Current or past eating disorder
- •Principal Investigator discretion related to the potential participant's ability to adhere to the study requirements including being able to come to the metabolic kitchen to pick-up food five days per week
- •Planning to relocate out of the State College area in the next 2 months
- •Unwilling to refrain from plasma/blood donations during the study
- •Previously diagnosed familial hypercholesterolemia
- •If a potential participant takes thyroid medicine, abnormal thyroid stimulating hormone (TSH) concentration (TSH outside of normal range of 0.5 - 4.5 mIU/L)
研究组 & 干预措施
Low BMI
BMI 18.5 - 22 kg/m^2 Intervention: Ketogenic diet 28 days
干预措施: Ketogenic Diet (Other)
High BMI
BMI 30-35 kg/m^2 Intervention: Ketogenic diet 28 days
干预措施: Ketogenic Diet (Other)
结局指标
主要结局
LDL-cholesterol concentration change from baseline
时间窗: 4 weeks
Assessed from fasting blood draw expressed in mg/dL. LDL-cholesterol will be measured directly via enzymatic assay. Change in LDL-cholesterol will be calculated as the mean of the end of diet measures (i.e., mean of day 29 and day 30 values) minus the mean of the baseline measures (i.e., mean of day 1 and day 2 values).
次要结局
- Endothelial function - Flow Mediated Dilation (FMD) change from baseline(4 weeks)
- Triglycerides concentration change from baseline(4 weeks)
- Total cholesterol concentration change from baseline(4 weeks)
- HDL-cholesterol concentration change from baseline(4 weeks)
- Concentration of LDL and triglyceride-rich lipoprotein subparticles change from baseline(4 weeks)
- Concentration of HDL subparticles change from baseline(4 weeks)
- Size of LDL, HDL, and triglyceride-rich lipoprotein particles change from baseline(4 weeks)
- Central systolic and diastolic blood pressure change from baseline(4 weeks)
- Brachial systolic and diastolic blood pressure change from baseline(4 weeks)
- Carotid-femoral pulse wave velocity change from baseline(4 weeks)
- Serum Insulin concentration change from baseline(4 weeks)
- Plasma glucose concentration change from baseline(4 weeks)
- Homeostatic model assessment for insulin resistance (HOMA-IR) change from baseline(4 weeks)
- Cholesteryl ester transfer protein (CETP) activity change from baseline(4 weeks)
- Lipoprotein lipase (LPL) activity change from baseline(4 weeks)
- Angiopoietin-Like Protein 3 (ANGPTL3) concentration change from baseline(4 weeks)
- Angiopoietin-Like Protein 4 (ANGPTL4) concentration change from baseline(4 weeks)
- Angiopoietin-Like Protein 8 (ANGPTL8) concentration change from baseline(4 weeks)
- Glucagon concentration change from baseline(4 weeks)
- Total adiposity change from baseline(4 weeks)
- Estimated visceral adipose tissue change from baseline(4 weeks)
- Alanine transaminase (ALT) change from baseline(4 weeks)
- Aspartate transaminase (AST) change from baseline(4 weeks)
研究者
Kristina Petersen PhD, APD, FAHA
Associate Professor
Penn State University