HealthyNCT07827014
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
A study testing Vanilla Protein Formula and Chocolate Protein Formula in people with Healthy, run by Qualia Life Sciences at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 21 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Vanilla Protein Formula and Chocolate Protein Formula
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2026to Jan 2027
- 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 21 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Qualia Life Sciences
Carlsbad, California, 92008
About this study
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.
Read the detailed description
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.
- Conditions
- Healthy
- Being tested
- Vanilla Protein Formula, Chocolate Protein Formula
- Keywords
- protein, cognitive function, consumer acceptability, tolerability, dietary supplement, collagen peptides, creatine, prebiotic fiber
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vanilla Protein FormulaDietary supplement
Also called Vanilla Protein Powder
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.
Chocolate Protein FormulaDietary supplement
Also called Chocolate Protein Powder
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.
| Study group | Role | What they receive |
|---|---|---|
| Vanilla Protein Formula | Experimental | 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. Receives: Dietary Supplement: Vanilla Protein Formula |
| Chocolate Protein Formula | Experimental | 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. Receives: Dietary Supplement: Chocolate Protein Formula |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in Safety and Tolerability Questionnaire symptom scores at 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.
Measured: Baseline to Day 15
Change from baseline in PROMIS Global Health (Global-10) T-scores at 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.
Measured: Baseline to Day 15
Secondary outcomes (3)
Overall product liking on the 9-point hedonic scale at Day 15, by flavor arm
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.
Measured: Day 15
Change from baseline in PROMIS v2.0 Cognitive Function - Abilities Short Form 8a T-score at 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.
Measured: Baseline to Day 15
Change from baseline in Safety and Tolerability Questionnaire symptom scores at 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.
Measured: Baseline to Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2026
- Study startOct 2026 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qualia Life Sciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- William Scuba, Principal investigator, Qualia Life Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07827014
- Sponsor's protocol ID
- QLS-025
- Status last verified
- Sep 2026
- First submitted
- 10 Sep 2026
- Last updated
- 18 Sep 2026
- 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 18 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07827014
- Acronym / sponsor ID
- QLS-025
- Conditions
- Healthy
- Keywords
- protein, cognitive function, consumer acceptability, tolerability, dietary supplement, collagen peptides, creatine, prebiotic fiber
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Qualia Life SciencesIndustry (pharma, biotech, devices)
- Study start
- Oct 2026 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 18 Sep 2026 (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 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.
Detailed description
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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vanilla Protein Formula | Experimental | Dietary Supplement: Vanilla Protein FormulaParticipants 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. |
| Chocolate Protein Formula | Experimental | Dietary Supplement: Chocolate Protein FormulaParticipants 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. |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (12 listed)
- 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
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 |
|---|---|---|
| Vanilla Protein FormulaAlso: Vanilla Protein PowderA 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. | Dietary supplement | Vanilla Protein Formula |
| Chocolate Protein FormulaAlso: Chocolate Protein PowderA 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. | Dietary supplement | Chocolate Protein Formula |
Primary outcome
Change from baseline in Safety and Tolerability Questionnaire symptom scores at Day 15
Time frame: 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.
Change from baseline in PROMIS Global Health (Global-10) T-scores at Day 15
Time frame: 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.
3 secondary outcomes
Overall product liking on the 9-point hedonic scale at Day 15, by flavor arm
Time frame: Day 15
Change from baseline in PROMIS v2.0 Cognitive Function - Abilities Short Form 8a T-score at Day 15
Time frame: Baseline to Day 15
Change from baseline in Safety and Tolerability Questionnaire symptom scores at Day 7
Time frame: Baseline to Day 7
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 18 Sep 2026.
- 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.
William Scuba principal investigator
Qualia Life Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vanilla Protein Formula and Chocolate Protein Formula in people with Healthy, run by Qualia Life Sciences 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 9 inclusion and 12 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: looking for participants now, as of the sponsor's last update on 18 Sep 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. 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?
Contact William Scuba (760-456-7392, science@qualialife.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in Safety and Tolerability Questionnaire symptom scores at Day 15 (time frame: Baseline to Day 15). The study lists 2 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 18 Sep 2026.