Soup and Bread Recipe Impacts on Ingestive Behavior

NCT ID: NCT07146958

Last Updated: 2025-09-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-08-05

Study Completion Date

2025-11-05

Brief Summary

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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

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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

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Obesity &Amp; Overweight

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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.
Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Control Lunch Meal

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.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

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

Chia Enriched Lunch Meal

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.

Group Type EXPERIMENTAL

Chia seeds

Intervention Type OTHER

Chia seeds will be added to soup and bread recipes.

Hemp Enriched Lunch Meal

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.

Group Type EXPERIMENTAL

Hemp seeds

Intervention Type OTHER

Hemp seeds will be added to soup and bread recipes.

Interventions

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Chia seeds

Chia seeds will be added to soup and bread recipes.

Intervention Type OTHER

Hemp seeds

Hemp seeds will be added to soup and bread recipes.

Intervention Type OTHER

Placebo

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

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

\-

Exclusion Criteria

* 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
* 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
Minimum Eligible Age

25 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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USDA Beltsville Human Nutrition Research Center

FED

Sponsor Role lead

Responsible Party

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Janet Novotny

Research Physiologist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Janet Novotny, PhD

Role: PRINCIPAL_INVESTIGATOR

United States Department of Agriculture (USDA)

Locations

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U.S. Department of Agriculture, Beltsville Human Nutrition Research Center

Beltsville, Maryland, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Rita Rawal, PhD

Role: CONTACT

240-328-4779

Facility Contacts

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Rita Rawal, PhD

Role: primary

240-328-4779

Other Identifiers

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HS70 - Soup Meal Liking Study

Identifier Type: -

Identifier Source: org_study_id

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