US Army Research Institute of Environmental Medicine
Natick, Massachusetts, 01760, United States
NCT Number: NCT05408390
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.
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Notify Me17 year–39 year
All sexes
Interventional
Not applicable
Natick, Massachusetts, 01760, United States
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Low physical density (LPD) + low energy density (LED) foods. Participants receive breakfast, lunch and snack items engineered to have LPD and LED.
High physical density (HPD) + low energy density (LED) foods. Participants receive breakfast, lunch and snack items engineered to have HPD and LED.
Low physical density (LPD) + high energy density (HED) foods. Participants receive breakfast, lunch and snack items engineered to have LPD and HED.
High physical density (HPD) + high energy density (HED) foods. Participants receive breakfast, lunch and snack items engineered to have HPD and HED.
Time frame: Day 1 of each study arm.
Total energy intake from provided diet measured by weighing provided and uneaten foods.
Time frame: Days 1 and 2 of each study arm
Total carbohydrate intake from provided and self-selected diet measured by weighing provided and uneaten foods, and food records.
Time frame: Days 1 and 2 of each study arm
Total protein intake from provided and self-selected diet measured by weighing provided and uneaten foods, and food records.
Time frame: Days 1 and 2 of each study arm
Total fat intake from provided and self-selected diet measured by weighing provided and uneaten foods, and food records.
Time frame: Day 2 of each study arm
Energy intake from self-selected diet measured by food records.
Time frame: Immediately before, immediately after and 15 min after breakfast, lunch and afternoon snack on day 1 of each study arm
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.
Time frame: Immediately before, immediately after and 15 min after breakfast, lunch and afternoon snack on day 1 of each study arm
Level of fatigue measured by integer scale ranging from 0 (not tired) to 10 (total exhaustion)
Time frame: Immediately before, immediately after and 15 min after breakfast, lunch and afternoon snack on day 1 of each study arm
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).
Time frame: At breakfast, lunch and afternoon snack on day 1 of each study arm
Appearance, odor, flavor, texture, and overall acceptability of experimental foods rated on scale ranging from 1 (dislike extremely) to 9 (like extremely).
United States Army Research Institute of Environmental Medicine
Fed
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