Status:
COMPLETED
Effects of Energy and Physical Density Manipulation on Appetite
Lead Sponsor:
United States Army Research Institute of Environmental Medicine
Collaborating Sponsors:
US Army Research and Development Command- Soldier Center
Conditions:
Appetite
Eating Behavior
Eligibility:
All Genders
17-39 years
Phase:
NA
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 sensation...
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 5 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 4 2023
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT05408390
Start Date
July 5 2022
End Date
May 4 2023
Last Update
August 24 2023
Active Locations (1)
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1
US Army Research Institute of Environmental Medicine
Natick, Massachusetts, United States, 01760