Skip to content

Effects of Energy and Physical Density Manipulation on Appetite

Effects of Energy and Physical Density Manipulation on Appetite

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05408390
Enrollment
20
Registered
2022-06-07
Start date
2022-07-05
Completion date
2023-05-04
Last updated
2023-08-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Appetite, Eating Behavior

Keywords

Appetite, Eating behavior, Energy density

Brief summary

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.

Detailed description

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.

Interventions

OTHERLPD+LED

Low physical density (LPD) + low energy density (LED) foods. Participants receive breakfast, lunch and snack items engineered to have LPD and LED.

OTHERHPD+LED

High physical density (HPD) + low energy density (LED) foods. Participants receive breakfast, lunch and snack items engineered to have HPD and LED.

OTHERLPD+HED

Low physical density (LPD) + high energy density (HED) foods. Participants receive breakfast, lunch and snack items engineered to have LPD and HED.

OTHERHPD+HED

High physical density (HPD) + high energy density (HED) foods. Participants receive breakfast, lunch and snack items engineered to have HPD and HED.

Sponsors

US Army Research and Development Command- Soldier Center
CollaboratorUNKNOWN
United States Army Research Institute of Environmental Medicine
Lead SponsorFED

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
SINGLE (Subject)

Intervention model description

Randomized, single-blind, crossover study

Eligibility

Sex/Gender
ALL
Age
17 Years to 39 Years
Healthy volunteers
Yes

Inclusion criteria

* Body mass index (BMI) ≤ 30.0 kg/m2 * Willing to abstain from alcohol for 24 hours prior to and during days 1-2 of each study phase. * Willing to abstain from strenuous exercise for 24 hours prior to and during days 1-2 of each study phase. * Willing to abstain from a vegetarian/vegan diet or other highly restrictive diet (e.g., ketogenic diet, very high protein diet, Paleo diet) for two weeks prior to and throughout the study. * Willing to maintain body weight throughout study. * Willing to maintain usual diet (if not a restrictive diet), physical activity (aside from strenuous exercise limitation for 24 hours prior to and days 1-2 of each study phase) and nicotine use throughout study. * Willing to abstain from dietary supplements (e.g., metabolism boosters, appetite suppressants, weight loss aids) impacting appetite or metabolism (as determined by study PI) throughout the study. * Eats 3 meals per day at least 5 days/wk

Exclusion criteria

* Pregnant or lactating. * Taking prescription medications, other than a contraceptive, known to affect appetite, digestion and/or metabolism (e.g., anti-diabetic agents) (unless approved by study PI) * Any chronic medical condition that limits food intake or alters metabolism, appetite or digestive physiology (e.g., gastric bypass, gastrointestinal disease, dysphagia, diabetes). * Allergies and intolerances (e.g. gluten, dairy, nuts), unwillingness or inability to eat provided foods and beverages. * Score of ≥13 on the restraint scale or ≥9 on the disinhibition scale of the Eating Inventory * Weight gain or loss of \>5 lbs in the 2 weeks prior to study participation. * Not willing or unable to adhere to all study procedures and restrictions.

Design outcomes

Primary

MeasureTime frameDescription
Total energy intakeDay 1 of each study arm.Total energy intake from provided diet measured by weighing provided and uneaten foods.

Secondary

MeasureTime frameDescription
Protein intakeDays 1 and 2 of each study armTotal protein intake from provided and self-selected diet measured by weighing provided and uneaten foods, and food records.
Fat intakeDays 1 and 2 of each study armTotal fat intake from provided and self-selected diet measured by weighing provided and uneaten foods, and food records.
Self reported energy intakeDay 2 of each study armEnergy intake from self-selected diet measured by food records.
Carbohydrate intakeDays 1 and 2 of each study armTotal carbohydrate intake from provided and self-selected diet measured by weighing provided and uneaten foods, and food records.
FatigueImmediately before, immediately after and 15 min after breakfast, lunch and afternoon snack on day 1 of each study armLevel of fatigue measured by integer scale ranging from 0 (not tired) to 10 (total exhaustion)
Gastrointestinal symptomsImmediately before, immediately after and 15 min after breakfast, lunch and afternoon snack on day 1 of each study armHeartburn, 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).
AcceptabilityAt breakfast, lunch and afternoon snack on day 1 of each study armAppearance, odor, flavor, texture, and overall acceptability of experimental foods rated on scale ranging from 1 (dislike extremely) to 9 (like extremely).
AppetiteImmediately before, immediately after and 15 min after breakfast, lunch and afternoon snack on day 1 of each study armHunger, 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026