- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07765407
A Clinical Trial to Evaluate the Effects of a Supplement on Supporting Signs of a Healthy Metabolism
This study evaluates the effects of Love Wellness Energize, a dietary supplement, on supporting signs of a healthy metabolism in women aged 25-45 who report poor energy levels, perception of poor metabolism, difficulty with weight management, and feeling bloated. The trial is a single-arm, open-label, virtual study conducted over 4 weeks with 40 female participants.
Participants will dissolve one tablet of the test product in 16 fl.oz/475 mL of water twice daily and complete self-reported questionnaires at Baseline, Week 1, Week 2, Week 3, and Week 4. The primary endpoint is change in metabolism support, and secondary endpoints include perceptions of energy, bloating after hydration, and weight management support.
연구 개요
상태
개입 / 치료
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
-
-
Nevada
-
Las Vegas, Nevada, 미국, 89101
- Citruslabs
-
-
참여기준
자격 기준
공부할 수 있는 나이
- 성인
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- Be female.
- Be aged 25-45.
- Currently experiencing issues regarding all of the following: poor energy levels, perception of poor metabolism, difficulty with weight management, and feeling bloated.
- Generally healthy - does not live with any uncontrolled chronic disease.
- Willing to refrain from taking any products, prescription medications, or supplements that target metabolic health during the test period.
- Willing to maintain their current diet, sleep schedule, and activity level for the study duration.
- Resides in the United States.
Exclusion Criteria:
- Anyone with pre-existing chronic conditions that would prevent participants from adhering to the protocol, including cancer, mental health disorders, history of serious illness in the last three months, history of substance abuse, or planned surgery during the study period.
- Anyone diagnosed with and getting treated for Parkinson's disease.
- Anyone taking a prescription diabetes medication including but not limited to GLP-1 receptor agonist medications such as Ozempic, Wegovy, or Mounjaro.
- Anyone who drinks heavily (i.e., 8 or more alcoholic drinks per week for women or 15 or more alcoholic drinks per week for men).
- Any women who are pregnant, breastfeeding, or trying to conceive (or who will be at any point during the study period).
- Anyone testing or planning to test, in the next 4 weeks, a product for another research study.
- Anyone unwilling to follow the study protocol.
- Anyone with any allergies or sensitivities to any of the study product ingredients.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: Love Wellness Energize
|
All participants dissolve one tablet of Love Wellness Energize in 16 fl.oz/475
mL of water twice daily at 11 am and 3 pm (or after planned exercise) for 4 weeks.
Ingredients include Vitamin B1 15 mg, Vitamin B3 30 mg, Vitamin B6 10 mg, Vitamin B12 250 mcg, Calcium 100 mg, Magnesium 60 mg, Chromium 200 mcg, Sodium 310 mg, and Potassium 200 mg, among other excipients.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Change in Healthy Metabolism Support
기간: Baseline, Week 1, Week 2, Week 3, and Week 4
|
Self-reported perception of metabolism support, assessed via self-reported questionnaire
|
Baseline, Week 1, Week 2, Week 3, and Week 4
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Change in Self-Reported Energy
기간: Baseline, Week 1, Week 2, Week 3, and Week 4
|
Participants' perceived effects of the test product on energy levels, assessed via self-reported questionnaire
|
Baseline, Week 1, Week 2, Week 3, and Week 4
|
|
Change in Self-Reported Bloating After Hydration
기간: Baseline, Week 1, Week 2, Week 3, and Week 4
|
Participants' perceived effects of the test product on bloating after hydration, assessed via self-reported questionnaire
|
Baseline, Week 1, Week 2, Week 3, and Week 4
|
|
Change in Self-Reported Weight Management Support
기간: Baseline, Week 1, Week 2, Week 3, and Week 4
|
Participants' perceived effects of the test product on weight management support, assessed via self-reported questionnaire
|
Baseline, Week 1, Week 2, Week 3, and Week 4
|
공동 작업자 및 조사자
스폰서
협력자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- 20746
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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