Glycemic Effects of a Mediterranean-Style Dietary Pattern Containing Potatoes in Adults With Prediabetes
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 74
- 主要终点
- Change in HbA1c
研究概览
简要总结
The purpose of this research study is to determine if a healthy Mediterranean diet containing one medium potato/day has equivalent or non-different effects on risk factors for type 2 diabetes and heart disease compared to a healthy Mediterranean diet without potatoes in adults with prediabetes. Participants will be randomly assigned to one of the test diets and be asked to consume this diet for 12 weeks (84 days). Testing will be conducted at the beginning and end of the study.
详细描述
This is a 12-week, 2-arm parallel, randomized controlled feeding trial. Participants will be randomized to either a Mediterranean-style diet that includes 1 medium potato/day/2000 kcal replacing some grains , or a traditional-style Mediterranean dietary pattern without potatoes. All food will be provided for the 12-week study duration.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 25 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 25-65 years
- •Prediabetes assessed by an HbA1c of 5.7-6.4% or fasting glucose 100-125 mg/dL at screening
- •BMI 25-40 kg/m2 at screening
排除标准
- •HbA1c ≥6.5% at screening
- •LDL-C (calculated with the Martin-Hopkins equation) ≥190 mg/dL at screening
- •Hemoglobin <13.2 g/dL at screening
- •Fasting triglycerides >350 mg/dL at screening
- •≥10% change in body weight within the 6 months prior to enrollment
- •Blood pressure >140/90 mmHg at screening
- •Type 1 or type 2 diabetes
- •Prescription of anti-hypertensive, lipid-lowering, or glucose-lowering drugs
- •Intake of supplements that affect the outcomes of interest (i.e., lipid, blood pressure, or glucose lowering; vitamin C or multi-vitamins containing vitamin C) and are unwilling to cease during the study period.
- •History of liver, kidney, or autoimmune disease
- •Prior cardiovascular event (e.g., stroke, heart attack)
- •Current pregnancy or intention of pregnancy within the next 6 months
- •Lactation within the prior 6 months
- •Allergy/intolerance/sensitivity/dislike of any foods in the study menus
- •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
- •History of cancer at any site within the past 10 years (eligible if ≥10 years without recurrence) or non-melanoma skin cancer within the past 5 years (eligible if ≥5 years without recurrence)
- •Participation in another clinical trial within 60 days of baseline
- •Currently following a restricted or weight-loss diet
- •Prior bariatric surgery
- •Intake of >14 alcoholic drinks/week and/or not willing to avoid alcohol consumption for 48 hours prior to test visits
- •Principal Investigator discretion related to the potential participant's ability to adhere to the study requirements, including being able to come to attend visits
- •Does not speak and/or understand English
- •Unwilling to refrain from donating blood during the study
- •Weight <110 lb
研究组 & 干预措施
Traditional-style Mediterranean dietary pattern (MED)
A traditional-style Mediterranean diet that does not contain potatoes (potatoes are not a defining feature of this diet) and is higher in grains.
干预措施: Traditional-style Mediterranean diet (Other)
Mediterranean-style diet with potato (MED-P)
Mediterranean-style diet that includes 1 medium potato/day/2000 kcal replacing some grains
干预措施: Mediterranean-style diet with potatoes (Other)
结局指标
主要结局
Change in HbA1c
时间窗: 12-weeks
HbA1c will be assessed at baseline and 12-weeks and expressed as percentage . The change in HbA1c will be calculated by subtracting the baseline value from the 12 week value and expressed as percentage point change.
次要结局
- Change in fasting glucose(12-weeks)
- Change in mean glucose(12-weeks)
- Change in mean time in range(12-weeks)
- Change in glycemic variability(12-weeks)
- Change in fasting insulin(12-weeks)
- Change in homeostatic model of insulin resistance (HOMA-IR)(12-weeks)
- Change in LDL-Cholesterol(12-weeks)
- Change in apolipoprotein B(12-weeks)
- Change in non-HDL cholesterol(12-weeks)
- Change in Total Cholesterol(12-weeks)
- Change in HDL-Cholesterol(12-weeks)
- Change in Triglycerides(12-weeks)
- Change in C-reactive protein(12-weeks)
- Change in Central Systolic and Diastolic Blood Pressure(12-weeks)
- Change in Peripheral Systolic and Diastolic Blood Pressure(12-weeks)
- Change in Carotid-Femoral Pulse Wave Velocity(12-weeks)
- Change in particle size and number of LDL, HDL, triglyceride rich lipoproteins(12-weeks)
- Diet Satisfaction(12-weeks)
研究者
Kristina Petersen PhD, APD, FAHA
Associate Professor
Penn State University