Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| M-10975 | Other Identifier | US Army Medical Research and Development Command IRB |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| US Army Research and Development Command- Soldier Center | UNKNOWN |
Not provided
Not provided
Not provided
Not provided
As individuals tend to eat a constant weight or volume of food, manipulating physical and energy densities generally results in changes in energy intake without affecting subjective appetite sensations. However, relatively few studies have directly studied the interaction between physical and energy density manipulation. This study will determine the effects of foods that systematically vary in physical and energy density on ad libitum energy intake and subjective appetite ratings. Secondary outcomes will include gastrointestinal discomfort, fatigue and acceptability.
A historical challenge for military personnel operating in austere, remote environments is the ability to pack and carry enough food to sustain their operational and nutritional needs. To address this challenge and meet Army modernization requirements, US Army ration developers are developing a new ration to provide a lightweight, low volume, energy dense daily combat assault ration. The ration will use novel food processing techniques that remove air and water to reduce volume and increase physical density (g/cc) and will provide a high relative fat content to increase energy density (kcal/g or kcal/cc). As individuals tend to eat a constant weight or volume of food, manipulating physical and energy densities generally results in changes in energy intake without affecting subjective appetite sensations. However, relatively few studies have studied the independent effects on appetite and energy intake of increasing physical and energy densities of foods to the extent being targeted by the new ration, and none has directly studied the interaction between physical and energy density manipulation. This study will address that gap by determining the effects of foods that systematically vary in physical and energy density on ad libitum energy intake and subjective appetite ratings. Secondary outcomes will include gastrointestinal discomfort, fatigue and acceptability. Using a randomized, crossover design consisting of four separate phases, 20 participants will be provided with a standard base diet and experimental foods in which physical and energy density are systematically varied using different levels of mechanical compression and aeration, and different proportions of fat and carbohydrate, respectively. Consumption of the experimental foods at each of the physical and energy density combinations will be compulsory for 1 day while intake of the standard diet will be ad libitum. Total energy and macronutrient intake will be measured by collecting uneaten food items. Additionally, perceived appetite, gastrointestinal symptoms, fatigue and acceptability of the experimental food products will be measured by questionnaire.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low physical and energy density | Experimental |
| |
| High physical and low energy density | Experimental |
| |
| Low physical and high energy density | Experimental |
| |
| High physical and energy density | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LPD+LED | Other | Low physical density (LPD) + low energy density (LED) foods. Participants receive breakfast, lunch and snack items engineered to have LPD and LED. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Total energy intake | Total energy intake from provided diet measured by weighing provided and uneaten foods. | Day 1 of each study arm. |
| Measure | Description | Time Frame |
|---|---|---|
| Carbohydrate intake | Total carbohydrate intake from provided and self-selected diet measured by weighing provided and uneaten foods, and food records. | Days 1 and 2 of each study arm |
| Protein intake |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| J. Philip Karl | US Army Research Institute of Environmental Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| US Army Research Institute of Environmental Medicine | Natick | Massachusetts | 01760 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Apr 9, 2022 | May 21, 2023 | ICF_000.pdf |
Not provided
| ID | Term |
|---|---|
| D005247 | Feeding Behavior |
| ID | Term |
|---|---|
| D001522 | Behavior, Animal |
| D001519 | Behavior |
Not provided
Not provided
Randomized, single-blind, crossover study
Not provided
Not provided
Not provided
| HPD+LED | Other | High physical density (HPD) + low energy density (LED) foods. Participants receive breakfast, lunch and snack items engineered to have HPD and LED. |
|
| LPD+HED | Other | Low physical density (LPD) + high energy density (HED) foods. Participants receive breakfast, lunch and snack items engineered to have LPD and HED. |
|
| HPD+HED | Other | High physical density (HPD) + high energy density (HED) foods. Participants receive breakfast, lunch and snack items engineered to have HPD and HED. |
|
Total protein intake from provided and self-selected diet measured by weighing provided and uneaten foods, and food records.
| Days 1 and 2 of each study arm |
| Fat intake | Total fat intake from provided and self-selected diet measured by weighing provided and uneaten foods, and food records. | Days 1 and 2 of each study arm |
| Self reported energy intake | Energy intake from self-selected diet measured by food records. | Day 2 of each study arm |
| Appetite | Hunger, fullness, desire to eat and prospective consumption measured by 100mm visual analog scale. Range is 0 to 100, with higher scores indicating greater hunger/fullness/desire/prospective consumption. | Immediately before, immediately after and 15 min after breakfast, lunch and afternoon snack on day 1 of each study arm |
| Fatigue | Level of fatigue measured by integer scale ranging from 0 (not tired) to 10 (total exhaustion) | Immediately before, immediately after and 15 min after breakfast, lunch and afternoon snack on day 1 of each study arm |
| Gastrointestinal symptoms | Heartburn, bloating, abdominal pain, urge to vomit, nausea, gas, urge to defecate, overall gastrointestinal discomfort measured by 100mm visual analog scale. Range 0 (none) to 100 (extremely severe). | Immediately before, immediately after and 15 min after breakfast, lunch and afternoon snack on day 1 of each study arm |
| Acceptability | Appearance, odor, flavor, texture, and overall acceptability of experimental foods rated on scale ranging from 1 (dislike extremely) to 9 (like extremely). | At breakfast, lunch and afternoon snack on day 1 of each study arm |