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RECRUITING

NCT07827014

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

Sponsor: Qualia Life Sciences

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

21 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2026-10

Completion Date

2027-01

Last Updated

2026-09-18

Healthy Volunteers

Yes

Conditions

Healthy

Interventions

DIETARY_SUPPLEMENT

Vanilla Protein Formula

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.

DIETARY_SUPPLEMENT

Chocolate Protein Formula

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.

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

Locations (1)

Qualia Life Sciences

Carlsbad, California, United States