Obesity &Amp; OverweightNCT07146958
Soup and Bread Recipe Impacts on Ingestive Behavior
A study testing Chia seeds and Hemp seeds in people with Obesity &Amp; Overweight, run by USDA Beltsville Human Nutrition Research Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 years and olderHealthy volunteers can take part
- Conditions the study is for
- Obesity &Amp; Overweight
- 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
- 5 Aug 2025to 30 Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 (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
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 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
- 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 study plan
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: Voluntary Intake of Seed Enhanced Lunch Foods
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.
Read the detailed description
The objective of this study is to investigate the likability and potential satisfying effects of seed-enhanced foods. Seed consumption, owing to its high nutritional and functional characteristics, has become popular in recent years. Chia seeds, tiny edible seeds also known as Salvia hispanica L., are derived from a plant of the Lamiaceae family that grows in arid or semiarid climates. Hemp seeds are derived from the hemp plant Cannabis sativa. Although these seeds may seem different in appearance and taste, they share many similarities regarding their nutritional/health benefits. These seeds are a rich source of essential fatty acids (omega-3 and omega-6) and antioxidants. In addition, both chia and hemp seeds are sources of plant-based protein. Seeds also contain dietary fiber, which is essential to keep the digestive system healthy. The Dietary Guidelines for Americans recommend that adults consume 22-34 grams of fiber daily depending on age and sex. However, more than 90% of women and 97% of men do not meet the recommended fiber intake. Several studies in the past have shown the beneficial impact of supplementation with high-fiber foods exerting positive effects on appetite control and short-term satiety. Chia seeds are rich in soluble fiber that helps to lower cholesterol and delay starch digestion potentially impacting appetite and satiety. Various studies have reported the beneficial effects of chia seed consumption on cardiovascular disease, diabetes, and hypertension. Only a few studies have been conducted to investigate the satiating effects of chia or hemp seeds. These studies have mostly examined the influence of chia seed or hemp seeds as a mid-morning snack on short-term satiety and energy intake. No studies have examined how the use of chia or hemp seeds as a lunch meal ingredient could impact satiety. Therefore, the main objective of the present study is to investigate likability and potential satisfying effects of seed-enhanced foods.
- Conditions
- Obesity &Amp; Overweight
- Being tested
- Chia seeds, Hemp seeds, Placebo
- Keywords
- chia seeds, satiety, weight management
- Medical subject headings
- Obesity, Overweight
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 and bread recipes.
Hemp seedsOther
Hemp seeds will be added to soup and bread recipes.
PlaceboOther
The placebo will be food items that are not enriched with the intervention products.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Other: Hemp seeds |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lunch food intake
Mass of food eaten at lunch, weighed in grams
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 30 minutes post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2025
- Study start5 Aug 2025
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity &Amp; OverweightStudies 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
- Model description
- 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.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 24 participants (estimated)
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
- NCT07146958
- Sponsor's protocol ID
- HS70 - Soup Meal Liking Study
- Status last verified
- Aug 2025
- First submitted
- 21 Aug 2025
- Last updated
- 28 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Only de-identified information will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Voluntary Intake of Seed Enhanced Lunch Foods
- ClinicalTrials.gov ID
- NCT07146958
- Acronym / sponsor ID
- HS70 - Soup Meal Liking Study
- Conditions
- Obesity &Amp; Overweight
- Keywords
- chia seeds, satiety, weight management
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- USDA Beltsville Human Nutrition Research CenterUS federal agency
- Study start
- 5 Aug 2025 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 28 Aug 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.
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.
Detailed description
The objective of this study is to investigate the likability and potential satisfying effects of seed-enhanced foods. Seed consumption, owing to its high nutritional and functional characteristics, has become popular in recent years. Chia seeds, tiny edible seeds also known as Salvia hispanica L., are derived from a plant of the Lamiaceae family that grows in arid or semiarid climates. Hemp seeds are derived from the hemp plant Cannabis sativa. Although these seeds may seem different in appearance and taste, they share many similarities regarding their nutritional/health benefits. These seeds are a rich source of essential fatty acids (omega-3 and omega-6) and antioxidants. In addition, both chia and hemp seeds are sources of plant-based protein. Seeds also contain dietary fiber, which is essential to keep the digestive system healthy. The Dietary Guidelines for Americans recommend that adults consume 22-34 grams of fiber daily depending on age and sex. However, more than 90% of women and 97% of men do not meet the recommended fiber intake. Several studies in the past have shown the beneficial impact of supplementation with high-fiber foods exerting positive effects on appetite control and short-term satiety. Chia seeds are rich in soluble fiber that helps to lower cholesterol and delay starch digestion potentially impacting appetite and satiety. Various studies have reported the beneficial effects of chia seed consumption on cardiovascular disease, diabetes, and hypertension. Only a few studies have been conducted to investigate the satiating effects of chia or hemp seeds. These studies have mostly examined the influence of chia seed or hemp seeds as a mid-morning snack on short-term satiety and energy intake. No studies have examined how the use of chia or hemp seeds as a lunch meal ingredient could impact satiety. Therefore, the main objective of the present study is to investigate likability and potential satisfying effects of seed-enhanced foods.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Control Lunch Meal | Placebo comparator | Other: PlaceboA 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 | Experimental | Other: Chia seedsA 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 | Experimental | Other: Hemp seedsA 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. |
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 (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
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 and bread recipes. | Other | Chia Enriched Lunch Meal |
| Hemp seedsHemp seeds will be added to soup and bread recipes. | Other | Hemp Enriched Lunch Meal |
| PlaceboThe placebo will be food items that are not enriched with the intervention products. | Other | Control Lunch Meal |
Primary outcome
Lunch food intake
Time frame: 30 minutes after the start of the intervention
Mass of food eaten at lunch, weighed in grams
Feelings of hunger
Time frame: 30 minutes post treatment
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.
Feelings of satisfaction
Time frame: 30 minutes post intervention
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.
Feelings of fullness
Time frame: 30 minutes post intervention
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.
Ability to consume more food
Time frame: 30 minutes post intervention
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.
Desire to eat something sweet
Time frame: 30 minutes post intervention
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.
Desire to eat something salty
Time frame: 30 minutes post intervention
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.
Desire to eat something savory
Time frame: 30 minutes post intervention
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.
Desire to eat something fatty
Time frame: 30 minutes post intervention
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2026.
- Individual participant dataSharing planned: No. Only de-identified information will be shared.
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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 &Amp; Overweight, 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: under way, not looking for participants, as of the sponsor's last update on 28 Apr 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
Lunch food intake (time frame: 30 minutes after the start of the intervention). The study lists 9 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 28 Apr 2026; AzTrials last refreshed its copy on 29 Oct 2026.