NCT07447843Toborzás még nem indult
Safety and Tolerability of a Nutritional Formula Designed to Aid in Maintenance of Muscle During Periods of Caloric Restriction in Adults
An Adaptive, Randomized, Double-Blind, Placebo-Controlled Clinical Trial Assessing the Safety and Tolerability of Redefine, a Multi-Ingredient Nutritional Formulation Designed to Aid Lean Mass Preservation in Subjects Undergoing Caloric Restriction
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. márc. 5.
Rövid összefoglaló (regiszter, angolul)
Muscle loss during caloric restriction is a significant concern for metabolic health and physical function, yet there is limited evidence on interventions that simultaneously target multiple contributing pathways. This study investigates a multi-component formulation targeting these complementary pathways to address critical gaps in strategies for preserving lean mass during energy restriction. The primary goal of this study is to demonstrate the safety and tolerability of the product Redefine when used as an adjunct to a well-established caloric restriction regimen. Caloric restriction is known to result in unintended loss of skeletal muscle mass, which may negatively impact physical function and metabolic health. This study seeks to evaluate whether supplementation with Redefine may help preserve muscle mass and support the maintenance of healthy muscle function during caloric restriction. Secondarily, this study aims to explore whether Redefine supplementation may confer favorable changes in body composition in subjects participating in a caloric restriction regimen. This product consists of HMB, postbiotics and botanicals.
- Állapot (regiszter)
- Toborzás még nem indult
- Vizsgálattípus
- Beavatkozással járó
- Résztvevők száma
- 80 (tervezett)
- Első benyújtás
- 2026. febr. 25.
- Kezdés
- 2026. ápr.
- Elsődleges befejezés
- 2026. aug.
- Fő szponzor
- Nature's Sunshine Products, Inc.
- Betegségek
- Elhízás
- NCT-szám
- NCT07447843
Mit vállalsz
- Vizsgálat típusa: Beavatkozással járó
- Tervezett résztvevők: 80
- 2026. ápr. és az elsődleges befejezés (2026. aug.) között
- 1 helyszín, 1 országban
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
A(z) ClinicalTrials.gov regisztermezőiből összeállítva. A vizsgálat felépítését írja le.
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Korábbi kezelés
- Medical History and Concurrent Diseases:
- POCBP: Not using effective contraception.
- Medications/Supplements:
- Currently taking any nutritional supplements judged by the study coordinator to negate or camouflage the effects of the Study Products. See below for a brief list of explicitly allowed supplements.
- Use of Corticosteroids during the last 30 days
- Other Exclusionary Criteria:
Más betegség
- A serious, unstable illness including cardiac, hepatic, renal, gastrointestinal, respiratory, endocrinologic, neurologic, immunologic/rheumatological, or oncological/hematologic disease.
- Allergies related to ingredients in Study products
- Known infection with HIV, TB or Hepatitis B or C.
- Diabetes medications
- Any sound medical, psychiatric and/or social reason which, in the opinion of the PI, would preclude safe participation in this Study or interfere with compliance.
Laborértékek
- Explicitly allowed supplements: Fish Oil, Multivitamin, Magnesium, Vitamin D, Vitamin C
- Any concurrent condition (including clinically significant abnormalities in medical history, physical examination, or laboratory evaluations) which, in the opinion of the PI, would preclude safe participation in this study or interfere with compliance.
Egyéb
- Discontinuation of semaglutide treatment.
- Discontinuation of semaglutide treatment may be necessary in some cases. However, during the titration phase, GLP-1-related symptoms often do not require treatment discontinuation or reinitiation.
- Use of Narcotics during the last 30 days
- Use of Anticoagulants during last 30 days
- Use of controlled substances on a recreational basis during the last 30 days.
- Consumption of more than 1 alcoholic beverage per day (One beverage is a 5-ounce glass of wine, 12 ounces of beer, or one ounce of hard liquor)
- Inability to comply with Study and/or follow-up visits.
Kiket keres a vizsgálat
- Has been receiving a GLP-1 receptor agonist (semaglutide) treatment for weight loss, and is titrated to start receiving a weekly dose of 1 mg semaglutide (Inclusive)
- Body Mass Index (BMI): At study enrollment (participants that have achieved 1 mg titration), 25.0-34.9 (kg/m2) while receiving a GLP-1 receptor agonist (semaglutide) (inclusive)
- Willing to give written informed consent to participate in the Study
Életkor a regiszterben: 35 év – 65 év · Nem: nők és férfiak · Egészséges önkénteseket nem fogad
Helyszínek (1)
Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.
| Helyszín | Város | Ország | Helyszín állapota |
|---|---|---|---|
| Breakthrough Medical | Lehi | Egyesült Államok | Ismeretlen állapot |
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