NCT06771765

Brief Summary

This study will investigate food ingredients that may provide fullness to healthy adults after a meal. The ingredients will be incorporated into a lunch meal, and measures of hunger and fullness will be evaluated for several hours after the meal. Study subjects must be able to travel to the USDA Nutrition Center in Beltsville Maryland at scheduled times during the study for meals and study measures.

Trial Health

87
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
Completed

Started Feb 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

January 7, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 13, 2025

Completed
1 month until next milestone

Study Start

First participant enrolled

February 18, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 2, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 2, 2025

Completed
Last Updated

August 22, 2025

Status Verified

August 1, 2025

Enrollment Period

2 months

First QC Date

January 7, 2025

Last Update Submit

August 21, 2025

Conditions

Keywords

SatietyHungerFullnessNutrition

Outcome Measures

Primary Outcomes (5)

  • Feelings of Hunger

    Area Under the Curve for Visual Analogue Scale Assessment of Hunger versus Time

    0, 1, 2, 3, 4, 5, and 6 hours post treatment

  • Feelings of Satisfaction

    Area Under the Curve for Visual Analogue Scale Assessment of Satisfaction versus Time

    0, 1, 2, 3, 4, 5, and 6 hours post treatment

  • Feelings of Fullness

    Area Under the Curve for Visual Analogue Scale Assessment of Fullness versus Time

    0, 1, 2, 3, 4, 5, and 6 hours post treatment

  • Desire to Eat

    Area Under the Curve for Visual Analogue Scale Assessment of Desire to Eat versus Time

    0, 1, 2, 3, 4, 5, and 6 hours post treatment

  • Dinner Food Intake

    Weight of food eaten at dinner

    5 hours post intervention

Study Arms (3)

Control Lunch Meal

PLACEBO COMPARATOR

A lunch meal will be provided that is comprised of soup, bread, and a cookie. These items will be made from standard recipes. This arm will be a placebo comparator to meals made with chia seeds or hemp seeds, which may provide extra satiety.

Other: Control (placebo) group

Chia Enriched Lunch Meal

EXPERIMENTAL

A lunch meal will be provided that is comprised of soup, bread, and a cookie. 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, bread, and a cookie. 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, bread, and a cookie, and these food items will be served as a lunch meal.

Chia Enriched Lunch Meal

Hemp seeds will be added to soup, bread, and a cookie, and these food items will be served as a lunch meal.

Hemp Enriched Lunch Meal

This intervention is a lunch meal made from standard recipes. This intervention is the placebo control intervention.

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 (thus during the study period)
  • Presence of diabetes, diverticulitis, colitis, 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 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 intervention protocol

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

Interventions

Population Groups

Intervention Hierarchy (Ancestors)

DemographyPopulation Characteristics

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
Sponsor Type
FED
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Physiologist

Study Record Dates

First Submitted

January 7, 2025

First Posted

January 13, 2025

Study Start

February 18, 2025

Primary Completion

May 2, 2025

Study Completion

May 2, 2025

Last Updated

August 22, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations