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临床试验/NCT07152470
NCT07152470进行中(未招募)不适用

An Open Label 100 Person Study Evaluating a Natural Supplement for Weight Loss and Fat Loss in a Real World Setting.

Prostasis, LLC, dba Tonum Health1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2025年1月26日最近更新:

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
100
试验地点
1
主要终点
Total Weight Loss

研究概览

简要总结

The goal of this clinical trial is to learn if motus, a natural supplement can support healthy weight loss and fat loss in a real world setting without caloric restrictions or exercise requirements.

The main questions it aims to answer are:

Can a daily dose of motus result in statistically significant weight loss over 3 month and 6 month time points.

Participants will:

Weigh-in at baseline and every week thereafter Take drug motus every day Complete a food tracker app for every meal and drink product consumed daily Complete an exercise tracker for any activities performed daily Complete weekly satisfaction surveys on various topics

详细描述

A prospective, observational human study was conducted with 100 participants (ages 25-68, BMI ≥25) over an initial 12-week period, followed by a 12-week extension phase for 40 continuing participants. All subjects received motus (4-capsule daily dose) and were instructed to track food intake and exercise via food tracker app and digital fat measurement scales. No caloric restriction was mandated, and participants could optionally receive nutritional counseling. Weekly weigh-ins and quality of life surveys were completed. No financial compensation was provided. Participants were stratified post hoc into three behavioral groups based on food and activity logs reviewed by registered dietitians: Category 1 (healthy diet + exercise 4+ times per week), Category 2 (average diet + exercise 2-3 times per week), Category 3 (average diet + no exercise) and Category 4 (poor diet + no exercise).

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Willing to complete daily diary and weekly weigh-ins
  • Willing to take motus daily

排除标准

  • Unwilling to complete daily diary and weekly weigh-ins
  • Currently taking a prescribed weight loss medication
  • Currently or planning to be pregnant

结局指标

主要结局

Total Weight Loss

时间窗: 26 weeks

Total weight loss as a percentage of total body weight

Body Fat Loss

时间窗: 26 weeks

Total body fat loss compared to lean mass loss

次要结局

未报告次要终点

研究者

发起方
Prostasis, LLC, dba Tonum Health
申办方类型
Industry
责任方
Sponsor

研究点 (1)

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