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
2026년 9월 10일 업데이트: 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.
연구 개요
상세 설명
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.
연구 유형
중재적
등록 (추정된)
50
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
- 이름: William Scuba
- 전화번호: 760-456-7392
- 이메일: science@qualialife.com
연구 장소
-
-
California
-
Carlsbad, California, 미국, 92008
- 모병
- Qualia Life Sciences
-
-
참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
예
설명
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
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 다른
- 할당: 무작위화되지 않음
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: 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.
|
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.
다른 이름들:
|
|
실험적: 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.
|
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.
다른 이름들:
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Change from baseline in Safety and Tolerability Questionnaire symptom scores at Day 15
기간: 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
기간: 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
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Overall product liking on the 9-point hedonic scale at Day 15, by flavor arm
기간: 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
기간: 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
기간: 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
|
기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Just-About-Right (JAR) sweetness rating at Day 15, by flavor arm
기간: 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
기간: 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
기간: 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
|
공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 수석 연구원: William Scuba, Qualia Life Sciences
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (추정된)
2026년 10월 1일
기본 완료 (추정된)
2026년 12월 1일
연구 완료 (추정된)
2027년 1월 1일
연구 등록 날짜
최초 제출
2026년 9월 10일
QC 기준을 충족하는 최초 제출
2026년 9월 10일
처음 게시됨 (실제)
2026년 9월 18일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 9월 18일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 9월 10일
마지막으로 확인됨
2026년 9월 1일
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- QLS-025
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
아니요
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
아니
미국 FDA 규제 기기 제품 연구
아니
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .