Effects of Nutritive and Non-Nutritive Food Form and Learning on Cephalic Phase Responses
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Appetite Hormone Response
研究概览
简要总结
This study has two main aims: 1) To determine if ingestion of solid or beverage food forms will change appetite hormone responses, and 2) To determine whether "learning" (defined as 2 week daily consumption) about the metabolic consequence of ingesting solid or beverage foods forms varying in energy alters appetite hormone responses.
Beverage consumption has been implicated in the problem of obesity. However, the exact relationship between beverages, lower appetitive response and lower compensatory dietary responses remains unclear. This study aims to address this gap in the research. For aim 1, the null hypothesis is that the energy in beverage and solid forms will not affect appetite hormonal responses differently. The alternative hypothesis is that exposure to the energy-yielding beverage will elicit a lower appetitive hormone response compared to oral exposure to the solid food form. For aim 2, the null hypothesis is that learning will not change appetite hormone responses. The alternative hypothesis is that learning will decrease appetite hormone responses in the non-energy-yielding beverage more than in the energy-yielding beverage.
详细描述
The main aims will be studied in 3 phases. In phase 1,the unconditioned cephalic phase responses of participants to nutritive and non-nutritive beverage and solid food forms will be determined. In phase 2, participants will consume a randomly allocated solid food or beverage (either nutritive or non-nutritive) consecutively for 2 weeks. In phase 3, (which will occur immediately after the end of Phase 2), participants will be retested for their cephalic phase responses to determine if there is an effect of learning on appetite hormone response.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Body fat percentage > 25% for men and > 32% for women. BMI of 24 kg/m2- 37kg/m2
- •No purposeful use of foods or beverages that are sweetened with non-nutritive sweetener > 3 times a week
- •No purposeful addition of non-nutritive sweetener to foods and beverages >3 times a week
- •No Phenylketonuria (PKU)
- •Rate palatability of test load and food sample as greater than 5 on a 9 point category scale.
- •Be willing to eat at least 100 grams of carbohydrates for three days prior to each test day
- •Self-reported consumer of breakfast and lunch
- •Be willing to eat macaroni and cheese during breakfast-lunch hours
- •Not taking medications known to influence appetite
- •Non-smoker >1 year or more
- •Habitual activity pattern over the last 3 months and no plan to change this over the course of the study
- •Not on any extreme diet (e.g. Atkins Diet)
- •Weight stable (≤ 5 kg change over the last 3 months)
- •Not a restrained eater (have a dietary restraint score of <9 on the Three Factor Eating Questionnaire-Restraint section)
- •Not a disordered eater (Have a score of <20 in the Eating Attitudes Test-26)
- •Have not donated blood for at least 3 months prior to participating in the study
- •Indicate no plan to donate blood during, and for three months after the study
排除标准
- 未提供
研究组 & 干预措施
Not Learned: Non-nutritive bev to Nutritive bev
15 participants will be randomly assigned to eat 250 grams of non-nutritive solid consecutively for 2 weeks. After this conditioning, the cephalic phase response of half of these participants will be tested against a nutritive solid and act as a control for the learned effects.
干预措施: Learned: Non-nutritive beverage to Non-nutritive beverage (Behavioral)
Not Learned: Nutritive solid to Non-Nutritive solid
15 participants will be randomly assigned to eat 250 grams of nutritive solid consecutively for 2 weeks. After this conditioning, the cephalic phase response of half of these participants will be tested against a non-nutritive solid and act as a control for the learned effects.
干预措施: Learned: Nutritive solid to Nutritive solid (Behavioral)
Not Learned: Nutritive beverage to Non-Nutritive beverage
15 participants will be randomly assigned to drink 400 grams of nutritive beverage consecutively for 2 weeks. After this conditioning, the cephalic phase response of half of these participants will be tested against a non-nutritive beverage and act as a control for the learned effects.
干预措施: Learned: Nutritive beverage to Nutritive beverage (Behavioral)
Learned: Non-Nutritive solid to Non-Nutritive solid
15 participants will be randomly assigned to eat 250 grams of non-nutritive solid consecutively for 2 weeks. After this conditioning, the cephalic phase response of half of these participants will be tested against a non-nutritive solid to determine if cephalic phase response changes with learning.
干预措施: Not Learned: Non-nutritive solid to Nutritive solid (Behavioral)
Learned: Non-Nutritive beverage to Non-Nutritive beverage
15 participants will be randomly assigned to drink 400 grams of non-nutritive beverage consecutively for 2 weeks. After this conditioning, the cephalic phase response of half of these participants will be tested against a non-nutritive beverage to determine if cephalic phase response changes with learning.
干预措施: Not Learned: Nutritive beverage to Non-nutritive beverage (Behavioral)
Learned: Nutritive solid to Nutritive solid
15 participants will be randomly assigned to eat 250 grams of nutritive solid consecutively for 2 weeks. After this conditioning, the cephalic phase response of half of these participants will be tested against a nutritive solid to determine if cephalic phase response changes with learning.
干预措施: Not Learned: Non-Nutritive solid to Non-nutritive solid (Behavioral)
Learned: Nutritive beverage to Nutritive beverage
15 participants will be randomly assigned to drink 400 grams of nutritive beverage consecutively for 2 weeks. After this conditioning, the cephalic phase response of half of these participants will be tested against a nutritive beverage to determine if cephalic phase response changes with learning.
干预措施: Not Learned: Non-nutritive beverage to Nutritive beverage (Behavioral)
Not Learned: Non-Nutritive solid to Non-Nutritive solid
15 participants will be randomly assigned to eat 250 grams of non-nutritive solid consecutively for 2 weeks. After this conditioning, the cephalic phase response of half of these participants will be tested against a non-nutritive solid to determine if cephalic phase response changes with learning.
干预措施: Not Learned: Non-Nutritive solid to Non-Nutritive Solid (Behavioral)
结局指标
主要结局
Appetite Hormone Response
时间窗: week 1, week 2, week 3, week 4, week 7, week 8, week 9, week 10 (once a week over 136 minutes: 0, 14, 16, 18, 20, 22, 24, 26, 28, 30, 76, 106, 136 minutes)
Determine the appetite hormone responses to oral exposure of nutritive (energy-yielding) or non-nutritive (non-energy-yielding) sweetener in beverage or solid form. Then, determine whether the appetite hormone responses change after a 2-week learning period. Appetite hormones to be measured: Cholecystokinin, Glucagon-Like-Peptide-1, Ghrelin, Insulin, Pancreatic Polypeptide
次要结局
- Amount of meal ingested(week 1, week 2, week 3, week 4, week 7, week 8, week 9, week 10 (once a week, at 137 minutes to 180 minutes))
- Change in Appetite(week 1, week 2, week 3, week 4, week 7, week 8, week 9, week 10 (once a week, over 180 minutes: 0, 14, 30, 76, 106, 136, 180 minutes))
- Plasma Glucose(week 1, week 2, week 3, week 4, week 7, week 8, week 9, week 10 (once a week, over 136 minutes: 0, 14, 16, 18, 20, 22, 24, 26, 28, 30, 76, 106, 136 minutes))
研究者
Richard Mattes
Distinguished Professor
Purdue University