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

NCT07827014 | Recruiting

• 1 other identifier: QLS-025
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Healthy

Keywords

protein; cognitive function; consumer acceptability; tolerability; dietary supplement; collagen peptides; creatine; prebiotic fiber

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  Baseline to Day 15

Secondary Outcomes (3)

• Overall product liking on the 9-point hedonic scale at Day 15, by flavor arm

  Day 15

• Change from baseline in PROMIS v2.0 Cognitive Function - Abilities Short Form 8a T-score at Day 15

  Baseline to Day 15

• Change from baseline in Safety and Tolerability Questionnaire symptom scores at Day 7

  Baseline to Day 7

Other Outcomes (3)

• Just-About-Right (JAR) sweetness rating at Day 15, by flavor arm

  Day 15

• Adherence and study completion

  Days 1 to 15

• End-of-study Follow-Up Questionnaire: overall product experience, product rating, and purchase interest

  4-7 days after the final dose

Study Arms (2)

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.

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.

Dietary Supplement: Chocolate Protein Formula

Interventions

Vanilla Protein Formula DIETARY_SUPPLEMENT

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.

Also known as: Vanilla Protein Powder

Vanilla Protein Formula

Chocolate Protein Formula DIETARY_SUPPLEMENT

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.

Also known as: Chocolate Protein Powder

Chocolate Protein Formula

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Qualia Life Sciences: lead

Study Sites (1)

Qualia Life Sciences

Carlsbad, California, 92008, United States

RECRUITING

Study Officials

• William Scuba

  Qualia Life Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

William Scuba

CONTACT

760-456-7392; science@qualialife.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: This is an open-label study; no blinding procedures will be employed. Both participants and the research team will be aware of flavor assignment throughout the study.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 10, 2026
• First Posted: September 18, 2026
• Study Start: October 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): January 1, 2027
• Last Updated: September 18, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)