Qualia Testosterone+가 성인 남성의 테스토스테론 수치에 미치는 효능
The Efficacy of Qualia Testosterone+ on Testosterone Levels: A Triple-Armed Placebo-Controlled Parallel Study
This is a double-blind, placebo-controlled, triple-arm, parallel-group study evaluating the efficacy and tolerability of two distinct Qualia Testosterone+ formulations, novel dietary supplements formulated to support endogenous testosterone, in adult males aged 28-65. Approximately 75 participants will be assigned equally to receive Qualia Testosterone+ Formula 1, Qualia Testosterone+ Formula 2, or a matched placebo (3 capsules once each morning) for 28 days. The primary outcome is between-group change in total testosterone from baseline to day 28. Secondary outcomes include changes in free (dialysis) testosterone, the Aging Male Symptoms Scale, the PROMIS Short Form v1.0 - Fatigue 10a, and safety and tolerability assessments. Blood samples will be collected in a clinical laboratory setting, while symptom and safety assessments will be completed electronically at home.
연구 개요
상태
상태
정황
정황
개입 / 치료
개입 / 치료
상세 설명
Participants will be screened using the Aging Male Symptoms (AMS) Scale and the Androgen Deficiency in the Aging Male (ADAM) questionnaire to select candidates likely to have sub-optimal testosterone levels. Those meeting inclusion criteria will have total testosterone tested, and participants with baseline total testosterone of 500 ng/dL or less will be stratified and assigned using systematic allocation to one of three groups in a 1:1:1 ratio: Qualia Testosterone+ Formula 1, Qualia Testosterone+ Formula 2, or matched placebo.
Each participant will take 3 capsules of the assigned product once daily in the morning for 28 consecutive days. The placebo consists of vegetable/cellulose capsules containing inert rice powder, matched to the active capsules in appearance.
Blood samples for total and free testosterone (equilibrium dialysis) will be collected at baseline and day 26-28 at Ulta-affiliated phlebotomy sites, with morning collection recommended. Symptom questionnaires (AMS Scale, PROMIS Fatigue 10a, Safety and Tolerability survey) will be completed electronically at baseline, day 14, and day 28. A follow-up questionnaire will be completed at day 32-34. Regular check-in surveys will assess adherence and safety on days 1, 3, 7, 14, 21, and 28.
Statistical analyses will include paired t-tests or linear mixed-effects models for within-group differences, and linear mixed-effects models with fixed effects for group, time, and their interaction for between-group comparisons. The sample size was estimated to yield 80% power to detect an effect size of Cohen's d = 0.80 with a two-tailed t-test at a 0.05 significance level.
Note on allocation (added September 2026): Participants were assigned to study arms by systematic allocation rather than by random allocation. Earlier versions of this record described the design as randomized. The Allocation field and the design descriptions were corrected to Non-Randomized to reflect the method actually used. No other aspect of the study design, conduct, or analysis changed.
연구 유형
연구 유형
등록 (추정된)
등록
단계
단계
- 해당 없음
연락처 및 위치
연구 연락처
연구 연락처
- 이름: Colin Gardner, PhD
- 전화번호: 678-387-7924
- 이메일: colin@qualialife.com
연구 장소
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-
California
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Carlsbad, California, 미국, 92008
- 모병
- Qualia Life Sciences
-
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참여기준
자격 기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- 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
- Can read and write English
- Willing to not begin taking any new supplements during the study and continue taking any supplements they are currently using regularly
- Willing to complete questionnaires, records, and diaries associated with the study.
- Male participants aged 28-65
- A ≤500 ng/dL Total Testosterone at baseline
- Willing and able to visit a local blood draw facility for required blood sample collections
- Live within 20 miles of a suitable blood draw facility
- Willing to not consume any supplements containing Testosterone or botanicals known to impact hormones starting about 2 weeks prior to the baseline blood test and continuing through the intervention period.
Exclusion Criteria:
- Known food intolerances/allergy to any ingredients in the product
- 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, blood thinners, or any other psychiatric or neurological medicines
- On immunosuppressive therapy
- Individuals who were deemed incompatible with the test protocol
- Adults lacking capacity to consent
- Female
- Have Hypogonadism
- On Testosterone Replacement Therapy
- Taking Gonadotropin-releasing hormone (GnRH) injections or gonadotropins (hCG or FSH)
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 다른
- 할당: 무작위화되지 않음
- 중재 모델: 병렬 할당
- 마스킹: 더블
팔의 수
무기와 개입
참가자 그룹 / 팔참가자 그룹 / 팔 |
개입 / 치료개입 / 치료 |
|---|---|
|
실험적: Qualia Testosterone+ Formula 1
Participants receive 3 capsules daily of Qualia Testosterone+ Formula 1 dietary supplement for 28 days. |
Qualia Testosterone+ dietary supplement capsules (Formula 1 or Formula 2). Participants take 3 capsules daily with breakfast for 28 days. The supplement contains a proprietary blend of ingredients designed to support healthy testosterone levels. |
|
실험적: Qualia Testosterone+ Formula 2
Participants receive 3 capsules daily of Qualia Testosterone+ Formula 2 dietary supplement for 28 days. |
Qualia Testosterone+ dietary supplement capsules (Formula 1 or Formula 2). Participants take 3 capsules daily with breakfast for 28 days. The supplement contains a proprietary blend of ingredients designed to support healthy testosterone levels. |
|
위약 비교기: Placebo
Participants receive 3 capsules daily of matching placebo for 28 days. |
Matching placebo capsules. Participants take 3 capsules daily with breakfast for 28 days. |
연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Change in Total Testosterone Levels
기간: Baseline and Day 28
|
Between-group change in serum total testosterone concentration from baseline to Day 28, measured via venous blood draw analyzed by a CLIA-certified laboratory. Comparison across Qualia Testosterone+ Formula 1, Formula 2, and Placebo groups using linear mixed-effects models. |
Baseline and Day 28
|
2차 결과 측정
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Change in Free (Dialysis) Testosterone Levels
기간: Baseline and Day 28
|
Between-group change in serum free testosterone concentration measured by equilibrium dialysis from baseline to Day 28, via venous blood draw analyzed by a CLIA-certified laboratory. |
Baseline and Day 28
|
|
Change in Aging Males' Symptoms (AMS) Scale Score
기간: Baseline and Day 28
|
Between-group change in the Aging Males' Symptoms (AMS) Scale total score from baseline to Day 28. The AMS Scale is a validated 17-item self-reported questionnaire assessing symptoms associated with aging and declining testosterone in males. |
Baseline and Day 28
|
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Change in PROMIS Fatigue 10a Score
기간: Baseline and Day 28
|
Between-group change in the PROMIS Fatigue 10a short form T-score from baseline to Day 28. The PROMIS Fatigue 10a is a validated 10-item self-reported questionnaire measuring fatigue severity and its impact on daily functioning over the past 7 days. |
Baseline and Day 28
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Safety and Tolerability
기간: Baseline through Day 14 and Day 28
|
Within- and between-group changes from baseline to Days 14 and 28 in side effect profile using a custom Safety and Tolerability survey assessing symptoms including nausea, headache, mood changes, dizziness, bloating, itching, and sexual dysfunction. |
Baseline through Day 14 and Day 28
|
|
Within group difference in total testosterone
기간: Baseline to 28 days
|
To assess within-group differences from baseline to day 28 in Total Testosterone following Qualia Testosterone and Placebo supplementation. |
Baseline to 28 days
|
|
Within-group differences in Free (Dialysis) Testosterone
기간: baseline to day 28
|
To assess within-group differences from baseline to day 28 in Free (Dialysis) Testosterone following Qualia Testosterone and Placebo supplementation. |
baseline to day 28
|
공동 작업자 및 조사자
수사관
수사관
- 수석 연구원: Colin Gardner, PhD, Qualia Life Sciences, LLC
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
연구 시작
기본 완료 (추정된)
기본 완료
연구 완료 (추정된)
연구 완료
연구 등록 날짜
최초 제출
최초 제출
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
처음 게시됨
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
기타 연구 ID 번호
- QLS-022
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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