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临床试验/NCT06808061
NCT06808061已完成不适用

Effects of Kaneka KABP-51 Probiotic on Mood, Metabolism, Microbiome, and Body Composition in Healthy Adults

3 Waves Wellness2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2023年2月14日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
60
试验地点
2
主要终点
Body Weight

研究概览

简要总结

The objective of this study is to recruit 60 healthy moderately overweight subjects to participate in a research study investigating the effects of a specific probiotic strain (Lactobacillus plantarum KABP-51) on measures of psychological mood state, gut microbiome status, stress hormones, and body composition (body fat and muscle mass).

Our subjects will be measured 4 times over the course of a 12-week supplementation period - at Baseline, Week 4, Week 8, and Week 12.

We will have 2 groups (N=30 per group):

  • Probiotic Lactobacillus plantarum KABP-51
  • Placebo (maltodextrin/corn starch) Subjects will be recruited from local fitness/wellness centers and businesses (e.g. Plymouth Fitness; Planet Fitness; Marathon Sports, etc) using a simple flyer.

If volunteers meet the inclusion/exclusion criteria, they will review/sign the Informed Consent Form (ICF) before any Baseline measurements are collected.

Participants will meet weekly (via online webinar) for educational sessions on nutrition, exercise, sleep, stress, and related healthy lifestyle topics. This periodic contact is extremely effective for maintaining compliance with the supplementation regimen and reducing dropouts.

Our expectation is that this fairly simple 12-week design will show that the KABP-51 probiotic strain can support a variety of psychological benefits such as reduced stress and improved mood; as well as physical benefits such as improved stress hormone exposure and microbiome balance - all of which may lead to improved body composition (lower body fat and improved muscle mass).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • healthy moderately overweight

排除标准

  • Pregnant women
  • Inability to complete prescribed supplement regimen
  • Current use of incompatible medications or supplements (weight loss, mood support, or blood sugar balance)

结局指标

主要结局

Body Weight

时间窗: 12 weeks

次要结局

  • Microbiome Balance(12 weeks)
  • Mood State(12 weeks)

研究者

发起方
3 Waves Wellness
申办方类型
Industry
责任方
Principal Investigator
主要研究者

Shawn Talbott

Scientist

3 Waves Wellness

研究点 (2)

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