NCT07714096尚未招募不适用
Peanut Butter Glycemic Control, Cognition and Cardiovascular Health
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 56
- 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 look at the effect of consuming peanut butter at breakfast on blood sugar control, cognitive function, and heart disease risk factors in middle-aged adults with prediabetes.
详细描述
This is a 2-period, randomized, crossover study. In random sequence order participants will undergo each of the following conditions for 12 weeks with a ≥ 8-week washout between the two periods: 1) provision of 43 g/day (1.5 oz/day) of peanut butter with instructions to consume it as part of breakfast (or the first meal of the day); 2) instructions to continue usual intake with matched study contact and resource provision. Testing will be conducted at the beginning and end of each period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 40-65 years
- •BMI 25 to 40 kg/m2
- •HbA1c 5.7-6.4%
- •Low habitual intake of peanut butter (<0.5 Tablespoons/day on average)
- •Have a smartphone device or be willing to use one provided by the study
排除标准
- •Hemoglobin <13.2 g/dL for men or < 11.7 g/dL for women at screening
- •Fasting triglycerides >350 mg/dL at screening
- •LDL-cholesterol ≥190 mg/dL assessed by the Martin-Hopkins equation at screening
- •≥10% change in body weight within the 6 months prior to enrollment
- •Blood pressure >140/90 mmHg at screening
- •Diagnosed type 1 or type 2 diabetes
- •Takes any (prescription or over-the-counter) anti-hypertensive, lipid-lowering, glucose-lowering or body weight altering drugs
- •Intake of supplements that affect the outcomes of interest (i.e., lipids, blood pressure, glucose, body weight, and microbiome) and are unwilling to cease during the study period.
- •Unwilling to refrain from starting to take any supplements, vitamins, nutritional products, or health foods that are not prescribed by a doctor for the duration of the study
- •Self-reported history of diagnosed liver, kidney, or autoimmune disease
- •Self-reported history of a prior cardiovascular event (e.g., stroke, heart attack)
- •Self-reported history of diagnosed neurological disease (e.g. Alzheimer's Disease, Parkinson's Disease, Multiple Sclerosis)
- •Current pregnancy or intention of pregnancy within the next 12 months
- •Lactation within the prior 6 months
- •Peanut allergy/intolerance/sensitivity/dislike
- •Antibiotic use within the prior four weeks
- •Oral steroid use within the prior four 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
- •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
- •Does not speak and/or understand English
- •Unwilling to refrain from donating blood and/or plasma during the study
- •Weight <110 lb
- •Unwilling to contact study staff before enrolling in other health-related research and avoid participating in any research that may interfere with this study
- •For individuals taking thyroid medication: abnormal thyroid stimulated hormone (TSH) concentration, or change in dose of thyroid medication within the last 6 months
- •Principal Investigator discretion related to the potential participant's ability to adhere to the study requirements, including being able to come to attend visits
结局指标
主要结局
Change in HbA1c
时间窗: 12 weeks
HbA1c will be assessed at the beginning and end of each 12-week period and expressed as percentage. The change in HbA1c will be calculated as the post-condition value minus the pre-condition value and expressed as percentage point change.
次要结局
- Change in fasting glucose(12 weeks)
- Change in fasting insulin(12 weeks)
- Mean glucose(12 weeks)
- Mean glucose time in range(12 weeks)
- Glycemic variability(12 weeks)
- Change in homeostatic model of insulin resistance (HOMA-IR)(12 weeks)
- Difference in ambulatory processing speed(12 weeks)
- Difference in ambulatory working memory(12 weeks)
- Difference in ambulatory attention(12 weeks)
- Change in body weight(12 weeks)
- Difference in hunger(12 weeks)
- Difference in satiety(12 weeks)
- Change in total cholesterol(12 weeks)
- Change in LDL-cholesterol(12 weeks)
- Change in triglycerides(12 weeks)
- Change in HDL-cholesterol(12 weeks)
- Change in non-HDL cholesterol(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 diet quality(12 weeks)
研究者
Kristina Petersen PhD, APD, FAHA
Associate Professor
Penn State University
研究点 (1)
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