An Open-Label, Two-Arm Pilot Study of the Tolerability, Consumer Acceptability, and Exploratory Well-Being Outcomes of a Multi-Ingredient Protein Formula in Two Flavors in Healthy Adults
10 de septiembre de 2026 actualizado por: Qualia Life Sciences
This is an open-label, two-arm pilot study designed to evaluate the tolerability, consumer acceptability, and well-being outcomes of a multi-ingredient protein formula, available in two flavors (Vanilla Protein Formula and Chocolate Protein Formula), in generally healthy adults aged 21-65 with a BMI of 18.5-34.9
kg/m².
Approximately 50 participants will be allocated in a 1:1 ratio, balanced on age and gender, to receive either the vanilla or chocolate formula (approximately 25 participants per arm).
Participants will consume one serving (1 scoop, 51 grams) of their assigned product daily for 15 consecutive days, reconstituted in water or a beverage of their choice.
The primary outcomes are safety and tolerability, assessed via a Safety and Tolerability Questionnaire, and changes in global health assessed using the Global-10 scale.
Secondary outcomes include changes in cognitive function assessed using the PROMIS v2.0 Cognitive Function - Abilities 8a instruments, and consumer acceptability, measured using a 9-point hedonic liking scale.
All assessments are self-reported and completed electronically at home.
Descripción general del estudio
Estado
Estado
Reclutamiento
Condiciones
Condiciones
Intervención / Tratamiento
Intervención / Tratamiento
Descripción detallada
The test product is a multi-ingredient powdered dietary supplement combining fermented yeast protein, grass-fed bovine collagen peptides, creatine monohydrate, and a prebiotic fiber blend, formulated for once-daily consumption as a beverage and available in two flavors: vanilla and chocolate.
While the constituent ingredients are individually supported by existing literature, the tolerability, adherence, and consumer acceptability of this specific combination-along with its potential to influence self-reported measures of global health and cognitive function-have not yet been characterized.
Establishing this real-world tolerability and acceptability profile across both flavors is a necessary precursor to designing a larger, controlled efficacy trial.
This study employs a fully remote, decentralized design.
No in-person visits, laboratory testing, or specialized clinical procedures are required.
All study assessments will be completed electronically by participants using online questionnaires.
Participants will be allocated in a 1:1 ratio to the Vanilla Protein Formula or the Chocolate Protein Formula using systematic allocation stratified by gender and age.
Participants will consume one serving (1 scoop) daily for 15 consecutive days.
Assessments are completed at baseline (Day 0), Day 7, and Day 15, with an end-of-study follow-up questionnaire 4-7 days after the final dose; brief check-in surveys on Days 1, 3, 7, and 15 capture adherence and adverse events.
Tipo de estudio
Tipo de estudio
Intervencionista
Inscripción (Estimado)
Inscripción
50
Fase
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
Estudio Contacto
- Nombre: William Scuba
- Número de teléfono: 760-456-7392
- Correo electrónico: science@qualialife.com
Ubicaciones de estudio
-
-
California
-
Carlsbad, California, Estados Unidos, 92008
- Reclutamiento
- Qualia Life Sciences
-
-
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Sí
Descripción
Inclusion Criteria:
- Adults aged 21-65 years, inclusive
- Generally healthy, as determined by self-reported medical history and investigator judgment
- Body mass index 18.5-34.9 kg/m² (as operationally verified)
- Willing and able to consume the test product once daily for 15 days and to complete scheduled questionnaires
- Can read and write English.
- Provide voluntary, written, informed consent to participate in the study.
- Agree to provide a valid cell phone number and are willing to receive communications through text.
- Willing to complete questionnaires, records, and diaries associated with the study.
- Willing to not begin taking any new supplements during the study and continue taking any supplements they are currently using regularly
Exclusion Criteria:
- Known allergy or intolerance to any study-product component, including yeast-derived protein, bovine collagen, creatine, the prebiotic fiber blend, allulose, or Reb M.
- Women who are pregnant, breastfeeding, or planning to become pregnant or start breastfeeding during the trial
- Clinically significant gastrointestinal disorder that could confound tolerability assessment (e.g., inflammatory bowel disease, symptomatic irritable bowel syndrome, prior major GI surgery), per investigator judgment
- Known renal impairment or condition for which supplemental creatine is not advised
- Serious or unstable medical condition, or any condition that in the investigator's judgment would compromise participant safety or data integrity
- Participation in another interventional study within 30 days prior to enrollment
- Having any of the following conditions: Psychiatric conditions, neurologic disorders, endocrine disorders, cancer
- Having had a significant cardiovascular event in the past 6 months
- Taking MAO inhibitors, SSRIs, or any other psychiatric or neurological medicines
- On immunosuppressive therapy
- Having had surgery within the past 6 weeks or upcoming planned surgery in the next few months
- Adults lacking capacity to consent
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Otro
- Asignación: No aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Número de brazos
2
Armas e Intervenciones
Grupo de participantes/brazoGrupo de participantes/brazo |
Intervención / TratamientoIntervención / Tratamiento |
|---|---|
|
Experimental: Vanilla Protein Formula
Participants receive the Vanilla Protein Formula, a vanilla-flavored, multi-ingredient ready-to-mix powdered dietary supplement.
Participants consume one serving (1 scoop, 51 grams) daily for 15 consecutive days, reconstituted in water or a beverage of their choice.
|
A vanilla-flavored, multi-ingredient ready-to-mix powdered dietary supplement combining YESTEIN fermented yeast protein, grass-fed bovine collagen peptides, OptiCreatine creatine monohydrate, and FiberEssence prebiotic fiber blend, sweetened with allulose, Reb M, and coconut sugar.
Each 51-gram serving (1 scoop) provides 24 g protein, 2 g sugar, 3.5 g fat, and 5 g fiber.
Consumed once daily for 15 days.
Otros nombres:
|
|
Experimental: Chocolate Protein Formula
Participants receive the Chocolate Protein Formula, a chocolate-flavored, multi-ingredient ready-to-mix powdered dietary supplement.
Participants consume one serving (1 scoop, 51 grams) daily for 15 consecutive days, reconstituted in water or a beverage of their choice.
|
A chocolate-flavored, multi-ingredient ready-to-mix powdered dietary supplement combining YESTEIN fermented yeast protein, grass-fed bovine collagen peptides, OptiCreatine creatine monohydrate, and FiberEssence organic prebiotic fiber blend, flavored with cocoa powder and organic natural cocoa extract, sweetened with allulose, Reb M, and coconut sugar, and containing MCT oil powder.
Each 51-gram serving (1 scoop) provides 25 g protein, 2 g sugar, 3.5 g fat, and 5 g fiber.
Consumed once daily for 15 days.
Otros nombres:
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change from baseline in Safety and Tolerability Questionnaire symptom scores at Day 15
Periodo de tiempo: Baseline to Day 15
|
Safety and tolerability of daily use of the protein formula.
Each symptom item (increased anxiety/worry, headache, mood changes, stomach upset/nausea, dizziness, bloating, itching, sexual dysfunction) is rated 1 (not at all) to 5 (a great deal); higher score = worsening of symptoms.
|
Baseline to Day 15
|
|
Change from baseline in PROMIS Global Health (Global-10) T-scores at Day 15
Periodo de tiempo: Baseline to Day 15
|
PROMIS Global Health v1.2 (10 items) yields Global Physical Health (GPH) and Global Mental Health (GMH) T-scores (mean 50, SD 10 in the reference population); higher T-scores = better health.
Pooled across both flavor arms.
|
Baseline to Day 15
|
Medidas de resultado secundarias
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Overall product liking on the 9-point hedonic scale at Day 15, by flavor arm
Periodo de tiempo: Day 15
|
Overall liking rated 1 (dislike extremely) to 9 (like extremely); flavor and texture/mouthfeel/aftertaste are rated on the same scale.
Summarized separately for the vanilla and chocolate arms.
|
Day 15
|
|
Change from baseline in PROMIS v2.0 Cognitive Function - Abilities Short Form 8a T-score at Day 15
Periodo de tiempo: Baseline to Day 15
|
Eight items each scored 1-5 (raw score 8-40), converted to a T-score (mean 50, SD 10); higher = better perceived cognitive function.
Pooled across both flavor arms.
|
Baseline to Day 15
|
|
Change from baseline in Safety and Tolerability Questionnaire symptom scores at Day 7
Periodo de tiempo: Baseline to Day 7
|
Mid-study safety and tolerability.
Each symptom item (increased anxiety/worry, headache, mood changes, stomach upset/nausea, dizziness, bloating, itching, sexual dysfunction) is rated 1 (not at all) to 5 (a great deal); higher score = worsening of symptoms.
|
Baseline to Day 7
|
Otras medidas de resultado
Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Just-About-Right (JAR) sweetness rating at Day 15, by flavor arm
Periodo de tiempo: Day 15
|
Sweetness rated 1 (far too little) to 5 (far too much), with 3 = just about right.
Summarized separately by flavor arm.
|
Day 15
|
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Adherence and study completion
Periodo de tiempo: Days 1 to 15
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Proportion of scheduled servings consumed, from check-in surveys on Days 1, 3, 7, and 15, and the proportion of participants completing the Day 15 assessment.
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Days 1 to 15
|
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End-of-study Follow-Up Questionnaire: overall product experience, product rating, and purchase interest
Periodo de tiempo: 4-7 days after the final dose
|
Self-reported overall experience with the product, product rating, and purchase intent (5-point scale from 'definitely would not buy' to 'definitely would buy').
|
4-7 days after the final dose
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Patrocinador
Investigadores
Investigadores
- Investigador principal: William Scuba, Qualia Life Sciences
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Estimado)
Inicio del estudio
1 de octubre de 2026
Finalización primaria (Estimado)
Finalización primaria
1 de diciembre de 2026
Finalización del estudio (Estimado)
Finalización del estudio
1 de enero de 2027
Fechas de registro del estudio
Enviado por primera vez
Enviado por primera vez
10 de septiembre de 2026
Primero enviado que cumplió con los criterios de control de calidad
Primero enviado que cumplió con los criterios de control de calidad
10 de septiembre de 2026
Publicado por primera vez (Actual)
Publicado por primera vez
18 de septiembre de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización publicada
18 de septiembre de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
Última actualización enviada que cumplió con los criterios de control de calidad
10 de septiembre de 2026
Última verificación
Última verificación
1 de septiembre de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
Otros números de identificación del estudio
- QLS-025
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .