NCT07146958

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

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
2mo left

Started Aug 2025

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress84%
Aug 2025Jun 2026

Study Start

First participant enrolled

August 5, 2025

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

August 21, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 28, 2025

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2026

Last Updated

April 28, 2026

Status Verified

August 1, 2025

Enrollment Period

11 months

First QC Date

August 21, 2025

Last Update Submit

April 27, 2026

Conditions

Keywords

chia seedssatietyweight management

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 COMPARATOR

A 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.

Other: Placebo

Chia Enriched Lunch Meal

EXPERIMENTAL

A 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.

Other: Chia seeds

Hemp Enriched Lunch Meal

EXPERIMENTAL

A 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.

Other: Hemp seeds

Interventions

Chia seeds will be added to soup and bread recipes.

Chia Enriched Lunch Meal

Hemp seeds will be added to soup and bread recipes.

Hemp Enriched Lunch Meal
PlaceboOTHER

The placebo will be food items that are not enriched with the intervention products.

Control Lunch Meal

Eligibility Criteria

Age25 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

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

Location

MeSH Terms

Conditions

ObesityOverweight

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Janet Novotny, PhD

    United States Department of Agriculture (USDA)

    PRINCIPAL INVESTIGATOR

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
Model Details: This study will be a randomized crossover with three treatment periods. Subjects (n=24, approximately equal number of men and women) will be randomly assigned to a treatment sequence.
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.

Locations