A two-ingredient protein formula to test tolerability and well-being in healthy adults

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This open-label, two-arm pilot study will enroll about 50 generally healthy adults aged 21–65 with BMI 18.5–34.9 kg/m², randomized 1:1 to Vanilla or Chocolate protein formulas for 15 days. Participants will consume one 51-gram scoop daily, prepared in water or a preferred beverage, with fully remote electronic assessments at baseline, Day 7, Day 15, and a short follow-up 4–7 days after the final dose. Primary outcomes focus on safety and tolerability via a questionnaire and global health via the Global-10 scale; secondary outcomes include cognitive function tests using PROMIS Cognitive Function instruments and consumer acceptability. The study uses a decentralized design with no in-person visits, relying on online questionnaires and self-reported adherence and adverse events.

Why it matters

Who can join: the full rules

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

Where it's running

• Qualia Life Sciences
  Carlsbad, California, United States Recruiting

Study contacts

• Principal investigator: William Scuba — Qualia Life Sciences
• Study coordinator: William Scuba
• Email: science@qualialife.com
• Phone: 760-456-7392

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.