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

Qualia Life Sciences50 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Interventions

Vanilla Protein FormulaDIETARY_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.

Chocolate Protein FormulaDIETARY_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.

Eligibility

Sex: ALLMin age: 21 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: Baseline to Day 15

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: Baseline to Day 7

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts