Glycemic Effects of Substituting Pecans for Snacks Higher in Saturated Fat and Added Sugars in Individuals With Prediabetes
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 147
- 试验地点
- 1
- 主要终点
- Change in HbA1c
研究概览
简要总结
The purpose of this study is to investigate the effects of replacing snacks higher in saturated fats and added sugars with pecans on blood sugar control, heart health and diet quality in individuals with prediabetes. Participants will be randomized into one of two groups. Group 1 will consume 1.5 oz of pecans per day in place of normally consumed snacks higher in saturated fat and added sugars for 16 weeks. Group 2 will be asked to continue consuming their current diet for 16 weeks. Measures will be taken to evaluate blood sugar, heart health and dietary intake at the beginning and 16 weeks later.
详细描述
This is a 16-week randomized controlled trial. Participants will be randomized to either: 1) replace current snacks higher in saturated fat and added sugars with 1.5 oz/day of pecans; 2) continue their habitual diet. At the beginning and the end of the 16-week study period, testing will be conducted.
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% at screening
- •BMI 25-40 kg/m2 at screening
- •Low habitual nut consumption (<3.5 oz-eq/week) assessed at the telephone screening
- •Regularly eats snacks higher in saturated fat and/or added sugars assessed at the telephone screening
排除标准
- •LDL-C ≥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 or over-the-counter medications 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 12 months
- •Lactation within the prior 6 months
- •Pecan allergy/intolerance/sensitivity/dislike
- •Unwilling/unable to eat 1.5 oz of pecans every day as a snack during the duration of the study
- •Antibiotic use within the prior 4 weeks
- •Oral steroid use within the prior 4 weeks
- •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
- •Unwilling to contact study staff before enrolling in other health-related research and avoid participating in any research that may interfere with this study.
- •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 or plasma during the study
- •Weight <110 lb
- •If a potential participant takes thyroid medicine, abnormal thyroid stimulated hormone (TSH) concentration (TSH outside of normal range), or change in dose of thyroid medication within the last 6 months
研究组 & 干预措施
Pecan snacking group
Participants will be provided with 1.5 oz/day of pecans and asked to eat these instead of typically consumed snacks higher in saturated fat and added sugars.
干预措施: Pecan snacking (Behavioral)
Usual diet
Participants will be asked to continue consuming their usual diet. To match attention and resources, participants will be provided with a grocery voucher in approximately equivalent value to the pecans.
干预措施: Usual diet (Other)
结局指标
主要结局
Change in HbA1c
时间窗: 16 weeks
HbA1c will be assessed at baseline and 16-weeks and expressed as percentage . The change in HbA1c will be calculated by subtracting the baseline value from the 16 week value and expressed as percentage point change.
次要结局
- Change in homeostatic model of insulin resistance (HOMA-IR)(16 weeks)
- Change in the lipoprotein insulin resistance index(16 weeks)
- Change in LDL-Cholesterol(16 weeks)
- Change in non-HDL cholesterol(16 weeks)
- Change in Triglycerides(16 weeks)
- Change in C-reactive protein(16 weeks)
- Change in Peripheral Systolic and Diastolic Blood Pressure(16 weeks)
- Change in added sugar intake(16 weeks)
- Change in diet quality(16 weeks)
- Change in fasting glucose(16 weeks)
- Change in mean glucose(16 weeks)
- Change in mean time in range(16 weeks)
- Change in glycemic variability(16 weeks)
- Change in fasting insulin(16 weeks)
- Change in homeostatic model of insulin resistance (HOMA-IR)(16 weeks)
- Change in the lipoprotein insulin resistance index(16 weeks)
- Change in LDL-Cholesterol(16 weeks)
- Change in apolipoprotein B(16 weeks)
- Change in non-HDL cholesterol(16 weeks)
- Change in Total Cholesterol(16 weeks)
- Change in HDL-Cholesterol(16 weeks)
- Change in Triglycerides(16 weeks)
- Change in C-reactive protein(16 weeks)
- Change in Central Systolic and Diastolic Blood Pressure(16 weeks)
- Change in Peripheral Systolic and Diastolic Blood Pressure(16 weeks)
- Change in Carotid-Femoral Pulse Wave Velocity(16 weeks)
- Change in particle size and number of LDL, HDL, triglyceride rich lipoproteins(16 weeks)
- Change in Saturated fat intake(16 weeks)
- Change in added sugar intake(16 weeks)
- Change in diet quality(16 weeks)
研究者
Kristina Petersen PhD, APD, FAHA
Associate Professor
Penn State University