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临床试验/NCT03154606
NCT03154606
已完成
不适用

The Effects of Protein Source on Appetite Control, Satiety, and Subsequent Food Intake

Purdue University1 个研究点 分布在 1 个国家目标入组 35 人2017年3月21日

概览

阶段
不适用
干预措施
未指定
疾病 / 适应症
Appetitive Behavior
发起方
Purdue University
入组人数
35
试验地点
1
主要终点
Appetite Sensations of Hunger
状态
已完成
最后更新
7年前

概览

简要总结

The investigators propose a randomized, tightly-controlled breakfast trial in normal to overweight adults that will test whether the consumption of various types of protein-rich meals, containing ~24g of protein, will differentially alter food intake and meal initiation through proposed appetite and satiety mechanisms.

Aim 1: To examine whether the consumption of protein-rich meals that vary in protein quality (source) effect:

  1. postprandial feelings of hunger, fullness, desire to eat, prospective food consumption
  2. postprandial fluctuations in key appetite and satiety hormones
  3. eating initiation (i.e., motivation to eat (again))
  4. food cravings

Aim 2: To examine whether the consumption of protein-rich meals that vary in protein quality (source) effect:

  1. energy intake and food choice within the breakfast meal
  2. energy intake and food choice at the next eating occasion
  3. energy intake and food choice across the entire day

详细描述

Experimental Design: For 3 consecutive days/pattern, the participants will consume the respective treatment, at home, between 7-9 am and refrain from eating or drinking anything other than water until 12:00pm. On day 3, the participants will consume a standardized dinner at home the night before testing. On day 4, the participants will report to the research facility between 6-8 am to complete each 5-h testing day. Upon arrival to the facility, each participant will become familiarized with the testing day procedures. At time -15 min, a baseline set of computerized questionnaires (and/or blood samples) will be completed. At time +0 min, the respective breakfast treatment will be provided. Immediately following the first swallow of the breakfast meal, the participants will be given a questionnaire assessing the palatability. The participants will consume the breakfast within 20 min. After breakfast, the participants will continue to complete the questionnaires (and/or blood samples) every 30 min throughout the 5-h postprandial period. Throughout the day, the participants will also indicate if/when they would like to eat again. Regardless of the participants' meal timing request, at +240min post-breakfast, the participants will be provided with an ad libitum lunch. For the lunch meal, the participants will be given 30 min to "consume as much or as little as possible until comfortably full." Following these procedures, the participants will be allowed to leave the facility. The next day, a dietary recall will be performed to assess daily energy intake across the previous day. Lastly, on day 5 (at home), the participants will be provided with their respective breakfast along with additional carbohydrate and/or fat foods. Once the treatment breakfast is consumed, the participants can select and consume as much of the additional foods as they wish to consume within the breakfast time period (30 minutes).

注册库
clinicaltrials.gov
开始日期
2017年3月21日
结束日期
2018年7月27日
最后更新
7年前
研究类型
Interventional
研究设计
Crossover
性别
All

研究者

责任方
Principal Investigator
主要研究者

Heather Leidy

Associate Professor

Purdue University

入排标准

入选标准

  • Males and females
  • All ethnicities
  • Age: 20-40y
  • BMI/BMI Percentile: 18.5-29.9 kg/m2
  • Consumes breakfast (\>110 kcal prior to 10 am) at least 5 days/week for the past year
  • Never smoked or used other tobacco products
  • Willing to consume the study breakfasts
  • Generally healthy (as assessed by Medical History Questionnaire)
  • Health conscious as determined by answering yes to 3 pre-screening health \& lifestyle questions
  • Rating of ≥ 5 illustrating a minimum of "neither like nor dislike on a hedonic 9 pt taste test of all testing treatments

排除标准

  • Clinically diagnosed with an eating disorder
  • Metabolic, hormonal, and/or neural conditions/diseases that influence metabolism or appetite
  • Currently or previously on a weight loss or other special diet (in the past 6 months)
  • Gained/lost ≥4.5kg over the past 6 months
  • Donated (or plan to donate) blood through the American Red Cross within the past 6 months (or future 6 months)
  • Taking medication that would directly influence appetite (weight-loss drugs or antidepressant, steroid, or thyroid medication, unless dosage has been stable for at least 6 months)
  • Not willing or able to complete all study testing procedures
  • Clinically diagnosed with a sleeping disorder

结局指标

主要结局

Appetite Sensations of Hunger

时间窗: 12 testing days across ~6 months

Questionnaires assessing the appetitive sensations of hunger will be completed at specific times throughout each of the the 4-h testing days. The questionnaires contain VAS incorporating a horizontal line rating scale for each response. The questions are worded as "how strong is your feeling of" with anchors of "not all" to "extremely." A summation (area under the curve) will be calculated.

Appetite Sensations of Fullness

时间窗: 12 testing days across ~6 months

Questionnaires assessing the appetitive sensations of fullness will be completed at specific times throughout each of the 4-h testing days. The questionnaires contain VAS incorporating a horizontal line rating scale for each response. The questions are worded as "how strong is your feeling of" with anchors of "not all" to "extremely." A summation (area under the curve) will be calculated.

Appetite Sensations of Prospective Food Consumption

时间窗: 12 testing days across ~6 months

Questionnaires assessing the appetitive sensations of prospective food consumption will be completed at specific times throughout each of the the 4-h testing days. The questionnaires contain VAS incorporating a horizontal line rating scale for each response. The questions are worded as "how strong is your feeling of" with anchors of "not all" to "extremely." A summation (area under the curve) will be calculated.

Appetite Sensations of Desire to Eat

时间窗: 12 testing days across ~6 months

Questionnaires assessing the appetitive sensations of desire to eat will be completed at specific times throughout each of the the 4-h testing days. The questionnaires contain VAS incorporating a horizontal line rating scale for each response. The questions are worded as "how strong is your feeling of" with anchors of "not all" to "extremely." A summation (area under the curve) will be calculated.

次要结局

  • Perceived Food Cravings: Sweet(12 testing days across ~6 months)
  • Perceived Food Cravings: Salty(12 testing days across ~6 months)
  • Perceived Food Cravings: Savory-fat(12 testing days across ~6 months)
  • Perceived Food Cravings: Meat(12 testing days across ~6 months)
  • Perceived Energy: Energy(12 testing days across ~6 months)
  • Perceived Energy: Alertness(12 testing days across ~6 months)
  • Hormonal Response to Interventions: Plasma Ghrelin(12 testing days across ~6 months)
  • Hormonal Response to Interventions: Plasma GLP-1(12 testing days across ~6 months)
  • 24-h Energy Intake Dietary Recalls(12 testing days across ~6 months)
  • Perceived Breakfast Palatability(12 testing days across ~6 months)
  • Perceived Energy: Sleepiness(12 testing days across ~6 months)
  • Food Cravings Inventory(12 testing days across ~6 months)
  • Hormonal Response to Interventions: Plasma PYY(12 testing days across ~6 months)
  • Ad Libitum Breakfast(12 testing days across ~6 months)

研究点 (1)

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