Satiety Promoting Effects of Chia and Hemp Seeds
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Feelings of Hunger
研究概览
简要总结
This study will investigate food ingredients that may provide fullness to healthy adults after a meal. The ingredients will be incorporated into a lunch meal, and measures of hunger and fullness will be evaluated for several hours after the meal. Study subjects must be able to travel to the USDA Nutrition Center in Beltsville Maryland at scheduled times during the study for meals and study measures.
详细描述
STUDY DESIGN
This study will be a randomized crossover with three treatment periods. Subjects (n=24, approximately equal number of men and women) will be randomly assigned to a treatment sequence.
There will be three 2-day treatment periods separated by a break of ~0-4 weeks, depending on calendar conflicts such as holidays. The treatment period diets will differ in the inclusion of seeds into the recipes on the second day of each period. For all meals on Day 1 and breakfast & lunch on Day 2 of each treatment period, participants will consume a prescribed diet provided by the Beltsville Human Nutrition Research Center. The Day 1 meals and the Day 2 breakfast will be the same for each treatment period (scaled to each participant's intake needs for weight maintenance) so that the participants will be in the same food consumption state the day before the test day. Day 2 lunch will be the treatment meal and will consist of soup, bread, and a dessert item (cookie or brownie). Each of those treatment items (soup, bread, and dessert) will be made one of three ways: (1) by our standard recipe, (2) by our standard recipe modified to include chia seeds, or (3) by our standard recipe modified to include hemp seeds. Dinner on Day 2 will be provided for carry-out and will include a large serving of a dinner entrée, a dessert, and a snack. The Day 2 dinner foods will be provided in excess, and participants will be allowed to eat as much or as little as they like, and they will bring the uneaten portions back to the Beltsville Human Nutrition Research Center the next morning, at which time they will be given a light breakfast, ending the treatment period. The Day 2 dinner items will be weighed before and after the participants eat, and the amount consumed will be recorded and compared across the different recipes to determine if the inclusion of seeds in the recipe promoted satiety. Water will be allowed ad libitum, except that consumption of liquids will not be allowed for the hour before lunch and the hour before dinner on Day 2 of each treatment period.
Participants will complete a series of hunger, fullness, food, and mood related questionnaires during the study.
STUDY PROCEDURES
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 25 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- •Younger than 25 years
- •Known (self-reported) allergy or adverse reaction to study foods
- •Women who have given birth during the previous 12 months or who are pregnant/lactating or who plan to become pregnant over the upcoming 6 months (thus during the study period)
- •Presence of diabetes, diverticulitis, colitis, celiac disease, Crohn's disease, irritable bowel syndrome, gastrointestinal disease, pancreatic disease
- •History of bariatric surgery or other weight control surgery
- •Removal of a portion of the stomach or gastrointestinal tract
- •Actively trying to gain or lose weight at the time of the study recruitment or planning to gain or lose weight during the study periods
- •Diminished sense of taste and/or smell
- •Anorexia Nervosa and/or Bulimia
- •Smoking, vaping, or use of tobacco products in the past 3 months
- •Suspected or known physiological/mechanical GI obstruction
- •Use of certain medications or supplements (prescription or over-the-counter) that may interfere with the study objectives
- •Unable or unwilling to give informed consent or communicate with study staff
- •Self-report of alcohol or substance abuse within the past 12 months and/or current treatment for these problems (long-term participation in Alcoholics Anonymous is not an exclusion)
- •Other medical, psychiatric, or behavioral factors that in the judgment of the Principal Investigator may interfere with study participation or the ability to follow the intervention protocol
研究组 & 干预措施
Hemp Enriched Lunch Meal
A lunch meal will be provided that is comprised of soup, bread, and a cookie. These items will be made from standard recipes that have been enhanced with hemp seeds, which may provide extra satiety compared to the standard recipes in the placebo arm.
干预措施: Hemp Seeds (Other)
Chia Enriched Lunch Meal
A lunch meal will be provided that is comprised of soup, bread, and a cookie. These items will be made from standard recipes that have been enhanced with chia seeds, which may provide extra satiety compared to the standard recipes in the placebo arm.
干预措施: Chia Seeds (Other)
Control Lunch Meal
A lunch meal will be provided that is comprised of soup, bread, and a cookie. These items will be made from standard recipes. This arm will be a placebo comparator to meals made with chia seeds or hemp seeds, which may provide extra satiety.
干预措施: Control (placebo) group (Other)
结局指标
主要结局
Feelings of Hunger
时间窗: 0, 1, 2, 3, 4, 5, and 6 hours post treatment
Area Under the Curve for Visual Analogue Scale Assessment of Hunger versus Time
Feelings of Satisfaction
时间窗: 0, 1, 2, 3, 4, 5, and 6 hours post treatment
Area Under the Curve for Visual Analogue Scale Assessment of Satisfaction versus Time
Feelings of Fullness
时间窗: 0, 1, 2, 3, 4, 5, and 6 hours post treatment
Area Under the Curve for Visual Analogue Scale Assessment of Fullness versus Time
Desire to Eat
时间窗: 0, 1, 2, 3, 4, 5, and 6 hours post treatment
Area Under the Curve for Visual Analogue Scale Assessment of Desire to Eat versus Time
Dinner Food Intake
时间窗: 5 hours post intervention
Weight of food eaten at dinner
次要结局
未报告次要终点
研究者
Janet Novotny
Research Physiologist
USDA Beltsville Human Nutrition Research Center