Walnuts to Achieve Lasting NUTrition to Prevent Diabetes (WALNUT-Diabetes)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Palatability of Supplement
研究概览
简要总结
Prediabetes is a precursor of type 2 diabetes and an independent risk factor for cardiovascular disease, and currently affects one-quarter of the population of the United States. Individuals of overweight or obese BMI are at particular high risk for incident diabetes. A major modifiable risk factor for type 2 diabetes is poor dietary quality, and improvement of dietary quality can effectively delay and even prevent type 2 diabetes. Interventions to improve dietary quality thus far, however, rely on short-term intensive clinically designed meals replacing the entire diet which have poor sustainability. Persistent improvements to daily dietary patterns are often difficult without directed guidance, and overall dietary quality in the United States remains poor. The identification of a practical, daily dietary intervention to improve dietary quality and prevent diabetes in those at high risk remains unknown. The investigators propose to enroll 40 individuals with diagnosed prediabetes into a randomized controlled pilot study and provide a daily walnut supplementation intervention to determine feasibility and acceptability of the supplement. The investigators will then determine preliminary efficacy on metabolic markers and will investigate associations between dietary quality and circulating levels of branched-chain amino acids. The goal is to implement a whole-food supplement to improve dietary quality in patients with prediabetes as a tool for future type 2 diabetes prevention.
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
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female between 18-65 years of age at baseline living in the San Francisco Bay area.
- •BMI>25 m/kg2 (or >23 m/kg2 for individuals of Asian or South Asian ethnicity)
- •Documentation of prediabetes diagnosis as evidenced by the following criteria:
- •A fasting glucose 100-125 mg/dL, or a HbA1c measurement of 5.7-6.4%, OR a diagnosis of "prediabetes" or "impaired fasting glucose" in the past 6 months, identified through an electronic medical record query from patients at UCSF and through outside recruitment in the surrounding community
- •We will confirm eligibility of potential participants by repeating fasting capillary blood glucose measurements at the baseline visit to ensure that they have prediabetes
- •Written informed consent and ability for subject to comply with the requirements of the study.
排除标准
- •Pregnant or breastfeeding women at enrollment.
- •Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data, such as diverticulosis or diverticulitis.
- •Tree or peanut allergies
- •Unwilling to consume a daily walnut supplement.
- •Diagnosis of diabetes
- •On glucose lowering medications
- •Dietician-managed dietary intake, or personal or medical dietary restrictions that do not allow consumption of walnuts
- •Malabsorptive conditions including intestinal bypass surgery, pancreatitis, inflammatory bowel disease
研究组 & 干预措施
Walnuts Now
Will receive and be instructed to consume 1-oz individually wrapped daily walnut supplement packages for 12 weeks during intervention.
干预措施: Walnuts (Drug)
结局指标
主要结局
Palatability of Supplement
时间窗: 12 weeks
Palatability was measured using a visual analog scale, the scale range is 0-100, with 100 being the "Most Pleasant."
Number of Participants Recruited and Retained
时间窗: 12 weeks
Number of participants recruited and retained
Adherence to the Intervention
时间窗: 12 weeks
Adherence to the intervention was determined through daily food diaries. Participants detailed daily consumption of the walnut supplement on a calendar provided at the outset of the study. Percentage was determined as number of days consuming supplement over 84 days total.
次要结局
- Change in Diet Quality(0 weeks and 12 weeks)
- Fasting Glucose(0 weeks and 12 weeks)
- Change in Low Density Lipoprotein Levels(0 weeks and 12 weeks)
- Change in Hemoglobin A1c(0 weeks and 12 weeks)