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临床试验/NCT02497859
NCT02497859已完成不适用

Does Higher Protein Quality Breakfast Reduce Energy Intake When Following a Weight Loss Diet Plan?

Texas Tech University2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2015年9月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
20
试验地点
2
主要终点
Change in serum satiety and hunger hormones

研究概览

简要总结

The experiments in this study will assess if while following a reduced energy diet, eating a breakfast with higher protein quality will enhance weight loss compared to another breakfast with lower protein quality, but matched for energy density and macronutrient composition.

详细描述

There will be 2 experiments in this pilot study. Both will be randomized crossover study designs with subjects beginning on either an egg breakfast of higher protein quality or cereal breakfast of lower protein quality, and reversing to receive the breakfast not previously ingested. The subjects will consume breakfasts under supervision at our clinic on all days of the study, except for weekends. Subjects will be advised to continue eating their breakfast at home on weekends. All subjects will receive weight loss counseling and follow a weight loss diet for 2 weeks. Experiment 1 will test the hypothesis that when on a reduced calorie diet, intake of an egg breakfast compared to cereal breakfast increases satiety, reduces lunch time energy consumption and reduces dinner time energy consumption in clinical and free living condition. Insulin, glucagon-like peptide-1, peptide YY 3-36, ghrelin, plasma glucose, baseline and post intervention anthropomorphic measurements, and hunger questionnaires completed during the consumption of both breakfasts and subsequent meals will be compared. Experiment 2 will compare the effects of the two breakfasts on intake of foods considered tempting or highly palatable, and assessment of energy intake pre/post test lunch followed by offering brownies. It is hypothesized that consumption of an egg breakfast compared to cereal breakfast, will help in reducing intake of foods considered tempting.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 44 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Calculated BMI of 25.0-39.9 kg/m2
  • Sedentary (< 3 hours/week of moderate intensity physical activity)
  • Otherwise healthy

排除标准

  • ≥5% body weight loss or gain in the three months preceding the study
  • Post-menopausal (has not had period for 12 months)
  • Plans to begin an exercise program or change current exercise routines between initiation of study and final study
  • Anyone following a medical diet prescription
  • Anyone with a chronic disease including type II diabetes, hypothyroidism, hypoparathyroidism, cardiovascular disease, cancer of any type
  • Health conditions and chronic illness that contraindicate behavioral weight loss treatment using a low calorie diet
  • Anyone who is currently pregnant, or lactating
  • Medications that may influence or inhibit appetite, sensory functioning, or hormone signaling
  • Plans to begin taking any supplements that may influence weight loss
  • Report of medical condition or surgical intervention that affects swallowing or chewing ability
  • Anyone with a pacemaker or other internal medical device
  • Any practicing vegans or vegetarians
  • Any practicing gluten-free diet
  • Allergy, aversion, or dislike to any of the foods offered for meals

结局指标

主要结局

Change in serum satiety and hunger hormones

时间窗: Change (AU) from 30 minutes prior to breakfast consumption to 240 minutes post consumption.

Concentrations of ghrelin, GLP1, PYY 3-36, insulin, and serum glucose will be determined. This is only for experiment 1.

Energy intake (kcal) during ad libitum dinner

时间窗: Test day 14 (30 minutes for buffet).

This is for experiment 1.

Change in subjective hunger questionnaire (Visual Analog Scale)

时间窗: Change in scores (arbitrary units AU) from 30 minutes prior to breakfast consumption to 240 minutes post consumption.

Energy intake (kcal) during ad libitum lunch

时间窗: Test day 14 (30 minutes for buffet).

This is for experiment 1.

次要结局

  • Change in body weight in kilograms(Change in kilograms from test day 7 to test day 14.)
  • Change in blood pressure (mm Hg)(Change in mm Hg from test day 7 to test day 14.)
  • Change in waist and hip circumference in centimeters(Change in centimeters from test day 7 to test day 14.)
  • Change in fat mass and lean body mass percentage(Change in percentage from test day 0 to test day 14.)

研究者

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

Nikhil Dhurandhar

Professor

Texas Tech University

研究点 (2)

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