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临床试验/NCT03236116
NCT03236116已完成不适用

Almond Consumption and Glycemia

Purdue University5 个研究点 分布在 1 个国家目标入组 75 人开始时间: 2017年8月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
75
试验地点
5
主要终点
Change in HbA1c

研究概览

简要总结

This study will examine the effects of almonds consumed by adults with different body fat distributions on indices of carbohydrate and lipid metabolism.

详细描述

There is considerable evidence supporting a causal role for truncal visceral fat depots in glucose dysregulation. Individuals with large visceral fat depots have impaired suppression of free fatty acid release in response to insulin, elevated triglycerides and low concentrations of high density lipoprotein cholesterol. The high free fatty acid concentration may induce insulin resistance in the muscle and liver. There is more recent evidence that truncal subcutaneous fat depots are also problematic, though this literature is mixed. In contrast, gluteo-femoral fat depots have not been implicated in insulin resistance and dysregulation of carbohydrate metabolism. Failure to account for differences in the contributions of these depots will add noise to measurements of dietary interventions to mitigate glucose dysregulation. Previous studies have reported evidence indicating acute and chronic consumption of almonds improves glycemia. Acute effects are important indicators of health benefit, but longer-term trials, ones permitting identification of the effects of a dietary intervention on HbA1c, are more telling and clinically relevant. To more definitively establish the association between almond consumption and improved carbohydrate metabolism, we propose a six-month trial that contrasts the effects of almond consumption at optimal times of the day versus consumption of low nutrient dense snack foods on indices of carbohydrate metabolism, food intake and appetite in adults characterized by three distinct fat depots.

Participants will consume either almonds, or no nuts every day for 6 months. At baseline, participants will be weighed and undergo a DEXA scan to determine body fat composition and will be assigned a group. Blood will also be collected fasted and at stipulated times in response to a meal tolerance test to measure insulin, glucose, C-peptide, HbA1c, lipid panel, gut peptides, and compliance to the diet. Participants will be given links to complete appetite ratings and record food intake. Participants will report to the lab every two weeks to be weighed, and get a resupply of almonds (if in the almond group). At the two-week mark on months 2 and 4, participants will be weighed, blood will be taken to assess compliance to the diet, and links will be given to complete appetite ratings and record food intake. At month 6, all measurements from baseline will be repeated.

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 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Meeting one of the following body fat distribution criteria determined by DEXA:
  • High visceral fat
  • High gluteo-femoral fat
  • High truncal subcutaneous fat
  • 18-60 years
  • no nut allergies

排除标准

  • Not meeting one of the body fat distribution criteria
  • allergic to nuts

结局指标

主要结局

Change in HbA1c

时间窗: 6 months

HbA1c.

fasting glucose

时间窗: Baseline

fasting glucose,

GLP-1

时间窗: Baseline

GLP-1

GIP

时间窗: Baseline

GIP

change in LDL-cholesterol

时间窗: 6 months

LDL-cholesterol

Change in fasting glucose

时间窗: 6 months

fasting glucose

total cholesterol

时间窗: Baseline

total cholesterol

change in fasting insulin

时间窗: 6 months

fasting insulin

change in GIP

时间窗: 6 months

GIP

Change in GLP-1

时间窗: 6 months

GLP-1

fasting insulin

时间窗: Baseline

fasting insulin

HbA1c

时间窗: Baseline

HbA1c.

Body composition

时间窗: Baseline

Body composition

fasting triglycerides

时间窗: 6 months

fasting triglycerides

Change in Body weight

时间窗: Every two weeks for 6 months.

Body weight

LDL-cholesterol

时间窗: Baseline

LDL-cholesterol

C-peptide

时间窗: 6 months

Homa-IR

时间窗: 6 months

Homa-Percent Beta

时间窗: 6 months

Change in Body composition

时间窗: 6 months

Body composition

HDL-cholesterol

时间窗: Baseline

HDL-cholesterol

change in total cholesterol

时间窗: 6 months

total cholesterol

change in HDL-cholesterol

时间窗: 6 months

HDL-cholesterol

次要结局

  • Diet Quality(Three days (two non-consecutive week days and one weekend day) at baseline, month 2, 4, and 6.)
  • Compliance(Baseline, month 2, 4, and 6.)

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 (5)

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