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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

10. September 2026 aktualisiert von: Qualia Life Sciences
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.

Studienübersicht

Status

Rekrutierung

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Geschätzt)

50

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studienorte

  • Vereinigte Staaten
    • California
      • Carlsbad, California, Vereinigte Staaten, 92008
        • Rekrutierung
        • Qualia Life Sciences

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Ja

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Sonstiges
  • Zuteilung: Nicht randomisiert
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
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.
Nahrungsergänzungsmittel: 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.
Andere Namen:
  • Vanilla Protein Powder
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.
Nahrungsergänzungsmittel: 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.
Andere Namen:
  • Chocolate Protein Powder

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Change from baseline in Safety and Tolerability Questionnaire symptom scores at Day 15
Zeitfenster: Baseline to 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
Zeitfenster: Baseline to 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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Overall product liking on the 9-point hedonic scale at Day 15, by flavor arm
Zeitfenster: Day 15
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.
Day 15
Change from baseline in PROMIS v2.0 Cognitive Function - Abilities Short Form 8a T-score at Day 15
Zeitfenster: Baseline to 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.
Baseline to Day 15
Change from baseline in Safety and Tolerability Questionnaire symptom scores at Day 7
Zeitfenster: Baseline to 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.
Baseline to Day 7

Andere Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Just-About-Right (JAR) sweetness rating at Day 15, by flavor arm
Zeitfenster: Day 15
Sweetness rated 1 (far too little) to 5 (far too much), with 3 = just about right. Summarized separately by flavor arm.
Day 15
Adherence and study completion
Zeitfenster: Days 1 to 15
Proportion of scheduled servings consumed, from check-in surveys on Days 1, 3, 7, and 15, and the proportion of participants completing the Day 15 assessment.
Days 1 to 15
End-of-study Follow-Up Questionnaire: overall product experience, product rating, and purchase interest
Zeitfenster: 4-7 days after the final dose
Self-reported overall experience with the product, product rating, and purchase intent (5-point scale from 'definitely would not buy' to 'definitely would buy').
4-7 days after the final dose

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Qualia Life Sciences

Ermittler

  • Hauptermittler: William Scuba, Qualia Life Sciences

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

1. Oktober 2026

Primärer Abschluss (Geschätzt)

1. Dezember 2026

Studienabschluss (Geschätzt)

1. Januar 2027

Studienanmeldedaten

Zuerst eingereicht

10. September 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

10. September 2026

Zuerst gepostet (Tatsächlich)

18. September 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

18. September 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

10. September 2026

Zuletzt verifiziert

1. September 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Andere Studien-ID-Nummern

  • QLS-025

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

NEIN

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

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