Almond Consumption and Glycemia
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
- 是
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
Richard Mattes
Professor, Nutrition Sciences
Purdue University
