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临床试验/NCT05176197
NCT05176197进行中(未招募)不适用

Effects of Almonds on Glycemia in Adults With Elevated Hemoglobin A1c Concentrations

Purdue University2 个研究点 分布在 1 个国家目标入组 84 人开始时间: 2022年2月9日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
84
试验地点
2
主要终点
HbA1c

研究概览

简要总结

This study will examine the effects of regular almond consumption by individuals with elevated HbA1c on long-term glycemic control.

详细描述

Globally, it is projected that 418 million people will have impaired glucose tolerance by 2025. In the US, an estimated 34 million Americans have diabetes and 88 million, 33% of adults, have pre-diabetes. Impaired glucose tolerance is now manifesting in young adults where 20% of those 12-18 years of age have prediabetes. The current prevalence of Type 2 diabetes is over 8%, but it is projected that up to a third of Americans will develop diabetes in their lifetime. Additionally, the total annual cost of diabetes is approximately $327 which accounts for 25% of all US health care costs. Moreover, the costs rose 60% from 2007 to 2017 and this trend is continuing.

Diet is the preferred approach for management for this diet-related chronic disorder. Accumulating evidence suggests almond consumption decreases postprandial glycemia and may evoke a second meal effect, especially when they are consumed at breakfast or as an afternoon snack, which may aid in long-term glycemic control. Additionally, almond consumption can decrease total and LDL cholesterol, resulting in lower peripheral insulin resistance and cardiometabolic complications from type 2 diabetes mellitus. However, there is mixed evidence on the effects of almond consumption on HbA1c, a clinically important endpoint that provides a reliable measure of long-term glycemia and is correlated with risk of complications from diabetes. Thus, the investigators hypothesize a beneficial effect of regular almond consumption on long-term glycemic control in individuals with elevated baseline HbA1c.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
None

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • HbA1c >5.7%
  • BMI >20 kg/M^2
  • Prefer no use of medications, but if on medication, must have been on a stable dose for 3 months and plan to remain at the same level for the duration of the trial.
  • Healthy, good dentition
  • No nut allergies
  • >4.0 eating events per day
  • >=1 low nutrient density snack/d
  • No allergy to chocolate

排除标准

  • HbA1c within normal range
  • BMI <20 kg/M^2
  • Nut allergies

结局指标

主要结局

HbA1c

时间窗: Baseline

Change in HbA1c

时间窗: 16 weeks

HbA1c % change

次要结局

  • Glucose response to a meal tolerance test(Baseline and week 16)
  • Insulin response to a meal tolerance test(Baseline and week 16)
  • Chronic glycemia(Baseline, week 8 and week 16)
  • Hedonic survey(Baseline, week 4, week 8, week 12. week 16)
  • Food intake(Two days (one week day and one weekend day) at screening, week 8 and week 16.)
  • Body weight(Screening, baseline, week 4, week 8, week 12, and week 16)
  • Body composition(Baseline, week 16)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Richard Mattes

Professor, Nutrition Sciences

Purdue University

研究点 (2)

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