Almond Snacks and Satiety: a Randomized Intervention Trial Examining Acute and Chronic Effects
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Baseline level and change in oleoylethanolamide
研究概览
简要总结
This study is designed to compare two types of snacks (almonds or a cereal-based snack), eaten between meals, on measures of appetite, including appetitive hormones, self-reported feelings of hunger and fullness, and food intake at a buffet meal or in the home environment. The investigators hypothesize that the acute responses of appetitive hormones to a meal challenge protocol will differ between almond and cereal-based snacks based on multivariate models of satiety that will be predictive of ad libitum food intake at a dinner meal as part of the meal challenge protocol. Further, the investigators will estimate if, under free-living conditions, self-selected and self-reported food intake will show appropriate energy compensation for the added calories of the snacks, and determine if one type of snack is superior to the other in this regard.
详细描述
This study will use a randomized, parallel design that includes an almond snack intervention and a cereal-based snack intervention group. The almond intervention will be roasted, unsalted almonds at a level of 56 grams per day for 4 weeks. The cereal-based intervention will be isocaloric snacks provided in the form of a mixture of dry cereal, pretzels, and bread sticks for 4 weeks. A satiety test protocol will be done at the beginning and the end of the intervention period. Each test day will include measures of satiety responses to two standard meals, two snacks (either almonds or cereal-based snacks), and a dinner buffet. The protocol to evaluate satiety signals include tonic measures that may signal homeostasis to the brain and evaluation of episodic signals that may drive food intake In addition, other modulators of satiety will be tested including evaluation of preferences for palatable foods, self-reports of cravings and satiety using questionnaires, and perceived hunger, fullness, desire to eat.
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 (Outcomes Assessor)
盲法说明
Both the investigator and the participant will be aware of the group assignment. The persons handling the data and statistics will not be aware of the group assignment.
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Pre-menopausal
- •Body Mass Index 25 - 39.9 kg/m2
排除标准
- •Women who are post-menopausal or peri-menopausal
- •BMI < 25 or > 40 kg/m2
- •Allergies to tree nuts
- •Using any hormonal contraception including oral contraceptive, contraceptive patch, contraceptive ring, contraceptive injection (e.g. Depo-Provera), or contraceptive implant (e.g. Nexplanon/Implanon)
- •Menstrual cycle lengths < 25 days or > 45 days, or have amenorrhea, eumenorrhea, or polymenorrhea.
- •Pregnant or nursing within the last 6 months, or plan to become pregnant during the trial
- •Medical diagnoses of chronic diseases including cardiovascular or pulmonary diseases, renal disease, cancer, type 1 or type 2 diabetes mellitus, thyroid disease requiring medication, inflammatory bowel disease, irritable bowel disease, or those with recent major surgeries
- •current medical diagnosis of polycystic ovarian syndrome (PCOS).
结局指标
主要结局
Baseline level and change in oleoylethanolamide
时间窗: Baseline, 60 minutes before lunch meal, and 10, 30, 90, 150, 180, 210, 240, and 270 minutes after a lunch meal
Oleoylethanolamide measured by mass spectrometry in blood
Baseline level and change in hunger
时间窗: Baseline, every 30 minutes up to 480 minutes, and immediately before and after three meals
Self-reported feelings of hunger measured on a visual analog scale. Responses will be a marked on an unsegmented line from 0 or "not at all" to 100 or "extremely."
Baseline level and change in cholecystokinin
时间窗: Baseline, 60 minutes before lunch meal, and 10, 30, 90, 150, 180, 210, 240, and 270 minutes after a lunch meal
Cholecystokinin (CCK) measured in blood using an antibody based assay
Baseline level and change in peptide-YY
时间窗: Baseline, 60 minutes before lunch meal, and 10, 30, 90, 150, 180, 210, 240, and 270 minutes after a lunch meal
Peptide-YY (PYY) measured in blood using an antibody based assay
Baseline level and change in glucose-like peptide 1
时间窗: Baseline, 60 minutes before lunch meal, and 10, 30, 90, 150, 180, 210, 240, and 270 minutes after a lunch meal
Glucose-like peptide 1 (GLP-1) measured in blood using an antibody based assay
Baseline level and change in insulin
时间窗: Baseline, 60 minutes before lunch meal, and 10, 30, 90, 150, 180, 210, 240, and 270 minutes after a lunch meal
Insulin measured in blood using an antibody based assay
Baseline level and change in leptin
时间窗: Baseline, 60 minutes before lunch meal, and 10, 30, 90, 150, 180, 210, 240, and 270 minutes after a lunch meal
Leptin measured in blood using an antibody based assay
Baseline level and change in orexin
时间窗: Baseline, 60 minutes before lunch meal, and 10, 30, 90, 150, 180, 210, 240, and 270 minutes after a lunch meal
Orexin measured in blood using an antibody based assay
Baseline level and change in gastric inhibitory peptide
时间窗: Baseline, 60 minutes before lunch meal, and 10, 30, 90, 150, 180, 210, 240, and 270 minutes after a lunch meal
Gastric inhibitory peptide (GIP) measured in blood using an antibody based assay
Baseline level and change in ghrelin
时间窗: Baseline, 60 minutes before lunch meal, and 10, 30, 90, 150, 180, 210, 240, and 270 minutes after a lunch meal
Ghrelin measured in blood using an antibody based assay
Baseline level and change in endocannabinoid profiles
时间窗: Baseline, 60 minutes before lunch meal, and 10, 30, and 150 minutes after a lunch meal
Endocannabinoid profiles measured by mass spectrometry in blood
Baseline level and change in glucose
时间窗: Baseline, 60 minutes before lunch meal, and 10, 30, 90, 150, 180, 210, 240, and 270 minutes after a lunch meal
Glucose measured by standard chemistry in blood
Baseline level and change in satiety
时间窗: Baseline, every 30 minutes up to 480 minutes, and immediately before and after three meals
Self-reported feelings of fullness measured on a visual analog scale. Responses will be a marked on an unsegmented line from 0 or "not at all" to 100 or "extremely."
Change in food intake at a dinner meal
时间窗: Week 1 and 4
Calories consumed at a dinner meal following the satiety protocol
次要结局
- Body composition reference measurement(Week 1)
- Change in body weight(Weeks 0, 1, 2, 3, and 4)
- Premenstrual Syndrome(Week 0)
- Change in waist circumference(Week 0 and 4)
- Change in hip circumference(Week 0 and 4)
- Change in Food Choice(Baseline and following a lunch meal at Weeks 0 and 4)
- Food addiction questionnaire(Week 0)
- Change in liver stiffness(Week 0 and 4)
- Change in food craving(Week 0 and 4)
- Three factor eating inventory(Week 0)
- Change in lean body mass(Weeks 0, 1, 2, 3, and 4)
- Change in self-reported satiety(Week 0 and 4)
- Eating behavior(Week 0)
- Genetic risk of obesity(Week 1)
- Change in liver fat(Week 0 and 4)
- Change in body fat(Weeks 0, 1, 2, 3, and 4)
- Change in total body water(Weeks 0, 1, 2, 3, and 4)
- Power of food questionnaire(Week 0)
- Change in dietary intake(Ten dietary recalls collected at home during weeks 1-4)
- Usual physical activity(Week 0)
- Change in metabolic rate(Baseline and 1 hour before lunch meal, 1 hour after lunch meal, and 1 hour after mid-afternoon snack)
- General health and well-being(Week 0)