Effects of Energy and Physical Density Manipulation on Appetite

NCT05408390 | Completed

• 2 other identifiers: 22-03HCM-10975
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Appetite; Eating Behavior

Keywords

Appetite; Eating behavior; Energy density

Outcome Measures

Primary Outcomes (1)

• Total energy intake

  Total energy intake from provided diet measured by weighing provided and uneaten foods.

  Day 1 of each study arm.

Secondary Outcomes (8)

• Carbohydrate intake

  Days 1 and 2 of each study arm

• Protein intake

  Days 1 and 2 of each study arm

• Fat intake

  Days 1 and 2 of each study arm

• Self reported energy intake

  Day 2 of each study arm

• Appetite

  Immediately before, immediately after and 15 min after breakfast, lunch and afternoon snack on day 1 of each study arm

Study Arms (4)

Low physical and energy density

EXPERIMENTAL

Other: LPD+LED

High physical and low energy density

EXPERIMENTAL

Other: HPD+LED

Low physical and high energy density

EXPERIMENTAL

Other: LPD+HED

High physical and energy density

EXPERIMENTAL

Other: HPD+HED

Interventions

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.

Low physical and energy density

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.

High physical and low energy density

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.

Low physical and high energy density

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.

High physical and energy density

Eligibility Criteria

• Age: 17 Years - 39 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• United States Army Research Institute of Environmental Medicine: lead
• US Army Research and Development Command- Soldier Center: collaborator

Study Sites (1)

US Army Research Institute of Environmental Medicine

Natick, Massachusetts, 01760, United States

Location

MeSH Terms

Conditions

Feeding Behavior

Condition Hierarchy (Ancestors)

Behavior, Animal; Behavior

Study Officials

• J. Philip Karl

  US Army Research Institute of Environmental Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: Randomized, single-blind, crossover study

Study Record Dates

• First Submitted: May 24, 2022
• First Posted: June 7, 2022
• Study Start: July 5, 2022
• Primary Completion: May 4, 2023
• Study Completion: May 4, 2023
• Last Updated: August 24, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)