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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.
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
Controlled feeding intervention: The Beltsville Human Nutrition Research Center will provide all meals to subjects during each 2-day treatment period. Meals will be prepared using traditional American foods with a macronutrient composition representative of a typical American diet. For meals on Day 1 and breakfast & lunch on Day 2 of each treatment period, participants will be instructed to eat all foods and only foods provided to them, with the exception of water, coffee, and tea. Coffee and tea intake will be limited to 2 cups per day. Consumption of coffee, tea, and water will be recorded by study subjects. Dinner and snack food for Day 2 of each treatment period will be provided in excess (about 3 times the participants expected calorie needs) and the participants will consume as much or as little of those foods as they like, but they will not be allowed to consume any other foods beyond the foods provided. Alcohol consumption will not be allowed during the intervention.
Body weight: Body weight will be measured at the beginning of each treatment period.
Questionnaires: Participants will be asked to complete a series of questionnaires.
Food Intake: Using an analytical scale, Day 2 dinner foods for each participant will be weighed before they are provided to the participants and after the uneaten foods are returned to the Beltsville Human Nutrition Research Center. The weight of the foods will be recorded.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control Lunch Meal | Placebo Comparator | 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. |
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| Chia Enriched Lunch Meal | Experimental | 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. |
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| Hemp Enriched Lunch Meal | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Chia Seeds | Other | Chia seeds will be added to soup, bread, and a cookie, and these food items will be served as a lunch meal. |
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| Measure | Description | Time Frame |
|---|---|---|
| Feelings of Hunger | Area Under the Curve for Visual Analogue Scale Assessment of Hunger versus Time | 0, 1, 2, 3, 4, 5, and 6 hours post treatment |
| Feelings of Satisfaction | Area Under the Curve for Visual Analogue Scale Assessment of Satisfaction versus Time | 0, 1, 2, 3, 4, 5, and 6 hours post treatment |
| Feelings of Fullness | Area Under the Curve for Visual Analogue Scale Assessment of Fullness versus Time | 0, 1, 2, 3, 4, 5, and 6 hours post treatment |
| Desire to Eat | Area Under the Curve for Visual Analogue Scale Assessment of Desire to Eat versus Time | 0, 1, 2, 3, 4, 5, and 6 hours post treatment |
| Dinner Food Intake | Weight of food eaten at dinner | 5 hours post intervention |
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Inclusion Criteria:
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Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Janet Novotny, PhD | United States Department of Agriculture (USDA) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| U.S. Department of Agriculture, Beltsville Human Nutrition Research Center | Beltsville | Maryland | 20705 | United States |
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| ID | Term |
|---|---|
| D044382 | Population Groups |
| ID | Term |
|---|---|
| D003710 | Demography |
| D011154 | Population Characteristics |
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| Hemp Seeds | Other | Hemp seeds will be added to soup, bread, and a cookie, and these food items will be served as a lunch meal. |
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| Control (placebo) group | Other | This intervention is a lunch meal made from standard recipes. This intervention is the placebo control intervention. |
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