Obesity PreventionNCT06771765
Soup Meal Satiety Study
A study testing Chia Seeds and Hemp Seeds in people with Obesity Prevention, run by USDA Beltsville Human Nutrition Research Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 years and olderHealthy volunteers can take part
- Conditions the study is for
- Obesity Prevention
- What is being tested?
- Chia Seeds and Hemp Seeds
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Feb 2025to 2 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- -
Who cannot join
- 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
Show all 15Show fewer
- 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
- Self-report of alcohol or substance abuse within the past 12 months and/or current treatment for these problems (long-term participation in Alcoholics Anonymous is not an exclusion)
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
U.S. Department of Agriculture, Beltsville Human Nutrition Research Center
Beltsville, Maryland, 20705
About this study
Official title: Satiety Promoting Effects of Chia and Hemp Seeds
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.
Read the detailed description
STUDY DESIGN
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.
There will be three 2-day treatment periods separated by a break of ~0-4 weeks, depending on calendar conflicts such as holidays. The treatment period diets will differ in the inclusion of seeds into the recipes on the second day of each period. For all meals on Day 1 and breakfast \& lunch on Day 2 of each treatment period, participants will consume a prescribed diet provided by the Beltsville Human Nutrition Research Center. The Day 1 meals and the Day 2 breakfast will be the same for each treatment period (scaled to each participant's intake needs for weight maintenance) so that the participants will be in the same food consumption state the day before the test day. Day 2 lunch will be the treatment meal and will consist of soup, bread, and a dessert item (cookie or brownie). Each of those treatment items (soup, bread, and dessert) will be made one of three ways: (1) by our standard recipe, (2) by our standard recipe modified to include chia seeds, or (3) by our standard recipe modified to include hemp seeds. Dinner on Day 2 will be provided for carry-out and will include a large serving of a dinner entrée, a dessert, and a snack. The Day 2 dinner foods will be provided in excess, and participants will be allowed to eat as much or as little as they like, and they will bring the uneaten portions back to the Beltsville Human Nutrition Research Center the next morning, at which time they will be given a light breakfast, ending the treatment period. The Day 2 dinner items will be weighed before and after the participants eat, and the amount consumed will be recorded and compared across the different recipes to determine if the inclusion of seeds in the recipe promoted satiety. Water will be allowed ad libitum, except that consumption of liquids will not be allowed for the hour before lunch and the hour before dinner on Day 2 of each treatment period.
Participants will complete a series of hunger, fullness, food, and mood related questionnaires during the study.
STUDY PROCEDURES
Controlled feeding intervention: The Beltsville Human Nutrition Research Center will provide all meals to subjects during each 2-day treatment period. Meals will be prepared using traditional American foods with a macronutrient composition representative of a typical American diet. For meals on Day 1 and breakfast \& lunch on Day 2 of each treatment period, participants will be instructed to eat all foods and only foods provided to them, with the exception of water, coffee, and tea. Coffee and tea intake will be limited to 2 cups per day. Consumption of coffee, tea, and water will be recorded by study subjects. Dinner and snack food for Day 2 of each treatment period will be provided in excess (about 3 times the participants expected calorie needs) and the participants will consume as much or as little of those foods as they like, but they will not be allowed to consume any other foods beyond the foods provided. Alcohol consumption will not be allowed during the intervention.
Body weight: Body weight will be measured at the beginning of each treatment period.
Questionnaires: Participants will be asked to complete a series of questionnaires.
- Participants will complete a questionnaire each study day (6 days total) with questions regarding general health, medications, exercise, and beverage consumption.
- Participants will complete a Three-Factor Eating Inventory on the first morning of the first study session to determine if they are restrained eaters.
- Participants will complete a Positive and Negative Affect Schedule questionnaire before dinner on the second day of each study session to determine if mood states are different among the three study sessions.
- Participants will complete a Visual Analogue Scale assessment of the following subjective feelings at the moment of the assessment: (1) Hunger, (2) Satisfaction, (3) Fullness, (4) Prospective Food Consumption, (5) Desire to Eat something sweet, salty, savory, or fatty. This assessment will be completed on Day 2 of each session, at the following times: immediately before lunch, immediately after lunch, 1 hour after lunch, 2 hours after lunch, 3 hours after lunch, 4 hours after lunch, 5 hours after lunch, and 6 hours after lunch (which will be about 30 minutes after finishing dinner).
Food Intake: Using an analytical scale, Day 2 dinner foods for each participant will be weighed before they are provided to the participants and after the uneaten foods are returned to the Beltsville Human Nutrition Research Center. The weight of the foods will be recorded.
- Conditions
- Obesity Prevention
- Being tested
- Chia Seeds, Hemp Seeds, Control (placebo) group
- Keywords
- Satiety, Hunger, Fullness, Nutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chia SeedsOther
Chia seeds will be added to soup, bread, and a cookie, and these food items will be served as a lunch meal.
Hemp SeedsOther
Hemp seeds will be added to soup, bread, and a cookie, and these food items will be served as a lunch meal.
Control (placebo) groupOther
This intervention is a lunch meal made from standard recipes. This intervention is the placebo control intervention.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Other: Hemp Seeds |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feelings of Hunger
Area Under the Curve for Visual Analogue Scale Assessment of Hunger versus Time
Measured: 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
Measured: 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
Measured: 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
Measured: 0, 1, 2, 3, 4, 5, and 6 hours post treatment
Dinner Food Intake
Weight of food eaten at dinner
Measured: 5 hours post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2025
- Study start18 Feb 2025
- Primary completion2 May 2025
- Study completion2 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity PreventionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- USDA Beltsville Human Nutrition Research Center
- Sponsor type
- US federal agency
- Responsible party
- Principal investigator, Janet Novotny, USDA Beltsville Human Nutrition Research Center
- Investigators
- Janet Novotny, PhD, Principal investigator, United States Department of Agriculture (USDA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06771765
- Sponsor's protocol ID
- HS69 - Soup Meal Satiety Study
- Status last verified
- Aug 2025
- First submitted
- 7 Jan 2025
- Last updated
- 22 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Satiety Promoting Effects of Chia and Hemp Seeds
- ClinicalTrials.gov ID
- NCT06771765
- Acronym / sponsor ID
- HS69 - Soup Meal Satiety Study
- Conditions
- Obesity Prevention
- Keywords
- Satiety, Hunger, Fullness, Nutrition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- USDA Beltsville Human Nutrition Research CenterUS federal agency
- Study start
- 18 Feb 2025 (actual)
- Primary completion
- 2 May 2025 (actual)
- Study completion
- 2 May 2025 (actual)
- First posted
- 13 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
STUDY DESIGN
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.
There will be three 2-day treatment periods separated by a break of ~0-4 weeks, depending on calendar conflicts such as holidays. The treatment period diets will differ in the inclusion of seeds into the recipes on the second day of each period. For all meals on Day 1 and breakfast \& lunch on Day 2 of each treatment period, participants will consume a prescribed diet provided by the Beltsville Human Nutrition Research Center. The Day 1 meals and the Day 2 breakfast will be the same for each treatment period (scaled to each participant's intake needs for weight maintenance) so that the participants will be in the same food consumption state the day before the test day. Day 2 lunch will be the treatment meal and will consist of soup, bread, and a dessert item (cookie or brownie). Each of those treatment items (soup, bread, and dessert) will be made one of three ways: (1) by our standard recipe, (2) by our standard recipe modified to include chia seeds, or (3) by our standard recipe modified to include hemp seeds. Dinner on Day 2 will be provided for carry-out and will include a large serving of a dinner entrée, a dessert, and a snack. The Day 2 dinner foods will be provided in excess, and participants will be allowed to eat as much or as little as they like, and they will bring the uneaten portions back to the Beltsville Human Nutrition Research Center the next morning, at which time they will be given a light breakfast, ending the treatment period. The Day 2 dinner items will be weighed before and after the participants eat, and the amount consumed will be recorded and compared across the different recipes to determine if the inclusion of seeds in the recipe promoted satiety. Water will be allowed ad libitum, except that consumption of liquids will not be allowed for the hour before lunch and the hour before dinner on Day 2 of each treatment period.
Participants will complete a series of hunger, fullness, food, and mood related questionnaires during the study.
STUDY PROCEDURES
Controlled feeding intervention: The Beltsville Human Nutrition Research Center will provide all meals to subjects during each 2-day treatment period. Meals will be prepared using traditional American foods with a macronutrient composition representative of a typical American diet. For meals on Day 1 and breakfast \& lunch on Day 2 of each treatment period, participants will be instructed to eat all foods and only foods provided to them, with the exception of water, coffee, and tea. Coffee and tea intake will be limited to 2 cups per day. Consumption of coffee, tea, and water will be recorded by study subjects. Dinner and snack food for Day 2 of each treatment period will be provided in excess (about 3 times the participants expected calorie needs) and the participants will consume as much or as little of those foods as they like, but they will not be allowed to consume any other foods beyond the foods provided. Alcohol consumption will not be allowed during the intervention.
Body weight: Body weight will be measured at the beginning of each treatment period.
Questionnaires: Participants will be asked to complete a series of questionnaires.
- Participants will complete a questionnaire each study day (6 days total) with questions regarding general health, medications, exercise, and beverage consumption.
- Participants will complete a Three-Factor Eating Inventory on the first morning of the first study session to determine if they are restrained eaters.
- Participants will complete a Positive and Negative Affect Schedule questionnaire before dinner on the second day of each study session to determine if mood states are different among the three study sessions.
- Participants will complete a Visual Analogue Scale assessment of the following subjective feelings at the moment of the assessment: (1) Hunger, (2) Satisfaction, (3) Fullness, (4) Prospective Food Consumption, (5) Desire to Eat something sweet, salty, savory, or fatty. This assessment will be completed on Day 2 of each session, at the following times: immediately before lunch, immediately after lunch, 1 hour after lunch, 2 hours after lunch, 3 hours after lunch, 4 hours after lunch, 5 hours after lunch, and 6 hours after lunch (which will be about 30 minutes after finishing dinner).
Food Intake: Using an analytical scale, Day 2 dinner foods for each participant will be weighed before they are provided to the participants and after the uneaten foods are returned to the Beltsville Human Nutrition Research Center. The weight of the foods will be recorded.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control Lunch Meal | Placebo comparator | Other: Control (placebo) groupA 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. |
| Chia Enriched Lunch Meal | Experimental | Other: Chia SeedsA 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. |
| Hemp Enriched Lunch Meal | Experimental | Other: Hemp SeedsA 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. |
Who may qualify
- Ages
- 25 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- -
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Chia SeedsChia seeds will be added to soup, bread, and a cookie, and these food items will be served as a lunch meal. | Other | Chia Enriched Lunch Meal |
| Hemp SeedsHemp seeds will be added to soup, bread, and a cookie, and these food items will be served as a lunch meal. | Other | Hemp Enriched Lunch Meal |
| Control (placebo) groupThis intervention is a lunch meal made from standard recipes. This intervention is the placebo control intervention. | Other | Control Lunch Meal |
Primary outcome
Feelings of Hunger
Time frame: 0, 1, 2, 3, 4, 5, and 6 hours post treatment
Area Under the Curve for Visual Analogue Scale Assessment of Hunger versus Time
Feelings of Satisfaction
Time frame: 0, 1, 2, 3, 4, 5, and 6 hours post treatment
Area Under the Curve for Visual Analogue Scale Assessment of Satisfaction versus Time
Feelings of Fullness
Time frame: 0, 1, 2, 3, 4, 5, and 6 hours post treatment
Area Under the Curve for Visual Analogue Scale Assessment of Fullness versus Time
Desire to Eat
Time frame: 0, 1, 2, 3, 4, 5, and 6 hours post treatment
Area Under the Curve for Visual Analogue Scale Assessment of Desire to Eat versus Time
Dinner Food Intake
Time frame: 5 hours post intervention
Weight of food eaten at dinner
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Janet Novotny, PhD principal investigator
United States Department of Agriculture (USDA)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Chia Seeds and Hemp Seeds in people with Obesity Prevention, run by USDA Beltsville Human Nutrition Research Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feelings of Hunger (time frame: 0, 1, 2, 3, 4, 5, and 6 hours post treatment). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2025.