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

Part of paid clinical trials in Carlsbad, California.

Sponsor
Qualia Life Sciences
Study ID
NCT07827014
Status
Recruiting
Apply to this trial

Conditions

  • Healthy

Eligibility Criteria

Sex
ALL
Age
21 Years - 65 Years
Healthy Volunteers
Accepted

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.
  • 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.

Study Details

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 Dates

First listed
Sep 18, 2026
Start date
Oct 31, 2026
Status verified
Sep 2026
Primary completion
Dec 31, 2026
Completion
Jan 31, 2027

Study Design

Enrollment
50 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • Experimental: Vanilla Protein Formula
    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.
  • Experimental: Chocolate Protein Formula
    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.

Primary Outcome Measure

Change from baseline in Safety and Tolerability Questionnaire symptom scores at Day 15 [ Time Frame: Baseline to Day 15 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Qualia Life SciencesCarlsbadCalifornia92008-

Find similar trials in Carlsbad, CA

By research site
Qualia Life Sciences· Carlsbad, CA

Related Studies