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临床试验/NCT01690936
NCT01690936已完成不适用

Effects of Chronic Almond Consumption at Meals or as Snacks on Appetite, Intake, Body Weight, Glycemia, Insulinemia and Lipids in Healthy Adults.

Purdue University1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2010年10月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
150
试验地点
1
主要终点
Postprandial glucose, insulin and lipids

研究概览

简要总结

Identifying snacks that do not contribute to positive energy balance is crucial in weight management. The satiating effects of almonds, coupled with their convenience and palatability make them a promising weight management aid. Therefore, this study aimed to examine the effects of almond consumption with meals versus snacks on outcomes such as appetite, energy intake, body weight, as well as blood glucose, insulin and lipid responses.

详细描述

Experiment protocol and measurements

i) Oral glucose tolerance test (OGTT) sessions

At baseline, participants attended a session where a standard OGTT with drinks containing 75 grams dextrose was performed following an overnight fasting. Serum glucose and insulin concentrations were measured at 0 and 120 minutes of the session. During the same session, height, weight (Tanita), body fat (air displacement plethysmography, BOD POD), waist circumference, and blood pressure were measured. Participants also completed a 24-hour dietary recall using a multi-pass interview method and standard questionnaires that assessed personality, eating behavior and habitual physical activity levels during the OGTT session. After the completion of this session, participants were asked to record their hourly appetite sensations, measured as "hunger", "fullness" and "desire to eat" on visual analog scales, during waking hours for a day before attending the next (clinical) visit. Participants repeated this session after four weeks of almond consumption.

ii) Acute feeding sessions

Within a week following the OGTT session, participants returned for an acute-feeding session, after an overnight fasting of at least 10 hours. This session began between 7:00 am and 8:00 am, and lasted for approximately 515 minutes. Upon arrival, an indwelling arm catheter was placed in the upper arm for blood sample collection. Participants rested for 15 minutes after catheter placement, before a baseline blood sample was drawn. Immediately after the first blood sample collection, a standard breakfast was served, and participants were instructed to consume the entire portion within 10 minutes. Subsequent blood samplings were performed at 15, 45, 60, 90, 120, 180, and 240 minutes after the breakfast, before a standard lunch was provided to the participants. Again, participants were given 10 minutes to consume the lunch, before blood samples were taken at similar intervals again (at 265, 295, 310, 340, 370, 430, and 490 minutes of the session). Participants randomized into the BF and LN groups received 43 grams of almonds together with their meals, while the MS and AS groups consumed 43 grams of almonds 120 minutes after breakfast and lunch respectively. Participants also recorded their "hunger", "fullness", and "desire to eat" sensations when blood samples were taken. During the acute-feeding session, activities that may alter appetite sensations (e.g. sleeping and watching movies containing food cues) were prohibited. Postprandial glucose, insulin and triacylglycerol concentrations were measured for all 15 samples collected from each participant. Participants in all almond groups group were also asked to rate their likings for the almonds they ingested using a general label magnitude scale, and their action responses to almonds using the "food action rating scale", a visual analog scale ranging from "I would eat the almonds only if I were forced to" to "I would eat this food every opportunity I had" anchored to the 2 extremes. This session was repeated again after four weeks of almond supplementation.

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 60 Years(Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Not taking any medication known to affect glycemia, lipid metabolism or appetite
  • •Regular breakfast consumers
  • •Eat at least 5 meals a day
  • •Weight stable
  • •Either one of the 6 conditions
  • •BMI 27-35
  • •Family history of diabetes
  • •Fasting glucose between 6.1-6.9 mmol/L
  • •2-hour glucose 7.8-11.1 mmol/L
  • •blood pressure >130/85 mmHg
  • •Waist >102cm (men) and >88cm (women)

排除标准

  • •Nut allergy
  • •Not willing to eat test foods and almonds

研究组 & 干预措施

Breakfast

Experimental

Almonds (43g/day) were consumed with breakfast for four weeks.

干预措施: Almonds 43g/day (Dietary Supplement)

Morning snack

Experimental

Almonds (43g/day) were consumed alone as morning snacks for four weeks.

干预措施: Almonds 43g/day (Dietary Supplement)

Lunch

Experimental

Almonds (43g/day) were consumed with lunch for four weeks.

干预措施: Almonds 43g/day (Dietary Supplement)

Afternoon snack

Experimental

Almonds (43g/day) were consumed alone as afternoon snacks for four weeks.

干预措施: Almonds 43g/day (Dietary Supplement)

Control no nuts

No Intervention

Avoided all nuts and seeds

结局指标

主要结局

Postprandial glucose, insulin and lipids

时间窗: 490 minutes

Responses of these parameters to a standard breakfast and a standard lunch for all participants, plus almonds at designated times according to group randomization.

Anthropometric measurements

时间窗: 4 weeks

Changes in body weight, BMI, fat mass, waist circumference over 4 weeks

Fasting blood biochemistries

时间窗: 4 weeks

Fasting glucose, insulin and lipids at baseline, week-1, 2, 3 and 4

Dietary intake

时间窗: 4 weeks

Dietary intakes were assessed at baseline, week-2, and week-4 of study

次要结局

  • Blood pressure(Baseline and week-4)
  • Appetite ratings(Baseline, week-2, and week-4)
  • Postprandial appetite sensations(490 minutes)

研究者

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

Richard Mattes

Distinguished Prof Foods and Nutrition

Purdue University

研究点 (1)

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