Soup and Bread Recipe Impacts on Ingestive Behavior
Voluntary Intake of Seed Enhanced Lunch Foods
1 other identifier
interventional
24
1 country
1
Brief Summary
The goal of the study is to determine the likability of seeds incorporated into lunch foods. The study will provide a better understanding of ways to make recipe alterations that may promote health and fullness.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Aug 2025
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 5, 2025
CompletedFirst Submitted
Initial submission to the registry
August 21, 2025
CompletedFirst Posted
Study publicly available on registry
August 28, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 30, 2026
April 28, 2026
August 1, 2025
11 months
August 21, 2025
April 27, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (9)
Lunch food intake
Mass of food eaten at lunch, weighed in grams
30 minutes after the start of the intervention
Feelings of hunger
Visual Analogue Scale assessment of hunger, assessed by participants placing a mark on a line, measured as millimeters across the line, with larger values meaning more hungry. To answer the question "How hungry do you feel?" one end of the line will be labeled "I am not hungry at all" and the other end of the line will be labeled "I have never been more hungry." This question is part of a validated ingestive behavior questionnaire.
30 minutes post treatment
Feelings of satisfaction
Visual analogue scale assessment of meal satisfaction, assessed by participants placing a mark on a line, measured as millimeters across the line, with larger values meaning more satisfied. To answer the question "How satisfied do you feel?" one end of the line will be labeled "I am completely empty" and the other end of the line will be labeled "I cannot eat another bite." This question is part of a validated ingestive behavior questionnaire.
30 minutes post intervention
Feelings of fullness
Visual analogue scale assessment of fullness, assessed by participants placing a mark on a line, measured as millimeters across the line, with larger values meaning more full. To answer the question "How full do you feel?" one end of the line will be labeled "Not at all full" and the other end of the line will be labeled "Totally full." This question is part of a validated ingestive behavior questionnaire.
30 minutes post intervention
Ability to consume more food
Visual analogue scale assessment of ability to consume more food, assessed by participants placing a mark on a line, measured as millimeters across the line, with larger values meaning more able to eat more food. To answer the question "How much do you think you can eat?" one end of the line will be labeled "Nothing at all" and the other end of the line will be labeled "A lot." This question is part of a validated ingestive behavior questionnaire.
30 minutes post intervention
Desire to eat something sweet
Visual analogue scale assessment of desire to consume something sweet, assessed by participants placing a mark on a line, measured as millimeters across the line, with larger values meaning more greater desire to eat something sweet. To answer the question "Would you like to eat something sweet?" one end of the line will be labeled "Yes, very much" and the other end of the line will be labeled "No, not at all." This question is part of a validated ingestive behavior questionnaire.
30 minutes post intervention
Desire to eat something salty
Visual analogue scale assessment of desire to consume something salty, assessed by participants placing a mark on a line, measured as millimeters across the line, with larger values meaning more greater desire to eat something salty. To answer the question "Would you like to eat something salty?" one end of the line will be labeled "Yes, very much" and the other end of the line will be labeled "No, not at all." This question is part of a validated ingestive behavior questionnaire.
30 minutes post intervention
Desire to eat something savory
Visual analogue scale assessment of desire to consume something savory, assessed by participants placing a mark on a line, measured as millimeters across the line, with larger values meaning more greater desire to eat something savory. To answer the question "Would you like to eat something savory?" one end of the line will be labeled "Yes, very much" and the other end of the line will be labeled "No, not at all." This question is part of a validated ingestive behavior questionnaire.
30 minutes post intervention
Desire to eat something fatty
Visual analogue scale assessment of desire to consume something fatty, assessed by participants placing a mark on a line, measured as millimeters across the line, with larger values meaning more greater desire to eat something fatty. To answer the question "Would you like to eat something fatty?" one end of the line will be labeled "Yes, very much" and the other end of the line will be labeled "No, not at all." This question is part of a validated ingestive behavior questionnaire.
30 minutes post intervention
Study Arms (3)
Control Lunch Meal
PLACEBO COMPARATORA lunch meal will be provided that is comprised of soup and bread. These items will be made from standard recipes. This arm will be a placebo comparator to meals made with chia seeds or help seeds, which may provide extra satiety.
Chia Enriched Lunch Meal
EXPERIMENTALA lunch meal will be provided that is comprised of soup and bread. These items will be made from standard recipes that have been enhanced with chia seeds, which may provide extra satiety compared to the standard recipes in the placebo arm.
Hemp Enriched Lunch Meal
EXPERIMENTALA lunch meal will be provided that is comprised of soup and bread. These items will be made from standard recipes that have been enhanced with hemp seeds, which may provide extra satiety compared to the standard recipes in the placebo arm.
Interventions
The placebo will be food items that are not enriched with the intervention products.
Eligibility Criteria
You may not qualify if:
- Younger than 25 years
- Known (self-reported) allergy or adverse reaction to study foods
- Women who have given birth during the previous 12 months or who are pregnant/lactating or who plan to become pregnant over the upcoming 6 months (which will overlap with the study period)
- Presence of diabetes, diverticulitis (inflammation of the large intestine), colitis (inflammation of the colon), celiac disease, Crohn's disease, irritable bowel syndrome, gastrointestinal disease, pancreatic disease
- History of bariatric surgery or other weight control surgery
- Removal of a portion of the stomach or gastrointestinal tract
- Actively trying to gain or lose weight at the time of the study recruitment or planning to gain or lose weight during the study periods
- Diminished sense of taste and/or smell
- Anorexia Nervosa and/or Bulimia
- Smoking, vaping, or use of tobacco products in the past 3 months
- Suspected or known physiological/mechanical gastrointestinal (GI) obstruction
- Use of certain medications or supplements (prescription or over-the-counter) that may interfere with the study objectives
- Unable or unwilling to give informed consent or communicate with study staff
- Other medical, psychiatric, or behavioral factors that in the judgment of the Principal Investigator may interfere with study participation or the ability to follow the study plan
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
U.S. Department of Agriculture, Beltsville Human Nutrition Research Center
Beltsville, Maryland, 20705, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Janet Novotny, PhD
United States Department of Agriculture (USDA)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- CROSSOVER
- Sponsor Type
- FED
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Research Physiologist
Study Record Dates
First Submitted
August 21, 2025
First Posted
August 28, 2025
Study Start
August 5, 2025
Primary Completion (Estimated)
June 30, 2026
Study Completion (Estimated)
June 30, 2026
Last Updated
April 28, 2026
Record last verified: 2025-08
Data Sharing
- IPD Sharing
- Will not share
Only de-identified information will be shared.