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临床试验/NCT07265934
NCT07265934已完成不适用

Beneficial Effects of a Food Supplement in Capsule Form and a Functional Chocolate Bar, Both Containing SYNBIO® Probiotic Strains and Grape Marc Plant Extract, on Healthy Adults.

Synbiotec Srl2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2025年6月10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
40
试验地点
2
主要终点
Change in perceived stress levels

研究概览

简要总结

An open-label, baseline-controlled (pre-post) pilot study to assess the maintenance and/or improvement of both physical and mental well-being in subjects who daily consume either a food supplement or a functional food containing both the SYNBIO® probiotic blend and the dry grape marc extract. A target number of 40 healthy individuals will be recruited who meet the inclusion and exclusion criteria, who will be assessed upon enrollment and who have signed informed consent. Subjects will be randomly assigned to either the functional food or dietary supplement groups.

详细描述

The present clinical trial is a pilot open label, baseline-controlled (pre/post) experimental study, with a, a 2-week run-in period, 4-week intervention period and a further 2-week follow-up period without intervention to evaluate the potential prolonged effect of the functional products. Specifically, the supplementation should improve the parameters related to physical and mental well-being of subjects. Healthy adult participants were recruited and randomized into two treatment groups in a 1:1 ratio. Subjects will be randomly assigned to either the functional food or dietary supplement groups. The study will consist of three meetings at the coordinating center. The first visit will be for enrollment. Through an interview, the investigator will verify that the volunteer meets the inclusion criteria. The volunteer will receive an informed consent form to sign and the study protocol information sheet, which explains the study's progress in a simple and clear manner. The investigator will answer any questions and concerns the volunteer may have regarding the study. Subjects will be randomly assigned to either the functional food or dietary supplement group. Recruited subjects will be given questionnaires to complete independently. The second meeting will take place at the end of the month of taking the study products and will consist of the administration of the end-of-treatment questionnaires. The third and final meeting, two weeks after the end of treatment, will involve completing the questionnaires again to assess the possible persistence of the benefits that taking the products may have produced.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 55 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • men and women between 18 and 55 years;
  • healthy based on medical history;
  • commitment to comply with all study procedures;
  • have a moderate level of stress (score 13-20) based on the Cohen Perceived Stress Scale (PSS-10);
  • signing of informed consent.

排除标准

  • significant acute or chronic illnesses and/or an immunocompromised state
  • pregnant women who are breastfeeding or planning to become pregnant during the study period
  • subjects with clinically significant gastrointestinal tract disease, subjects with allergy or sensitivity to the active or inactive ingredients of the investigational product
  • subjects who had used antibiotics in the month prior to enrolment or who had used probiotics continuously in the two months prior to enrolment.

结局指标

主要结局

Change in perceived stress levels

时间窗: After 4 weeks consumption of the study product

to evaluate the effect of the probiotic products on perceived stress levels measured using the Perceived Stress Scale (PSS). 5-point scale from 0 (never) to 4 (very often).

Change in perceived stress levels

时间窗: After 4 weeks consumption of the study product

to evaluate the effect of the probiotic products on perceived stress levels measured using the Perceived Stress Scale (PSS). 5-point scale from 0 (never) to 4 (very often).

次要结局

  • Assessment of sleep quality(After 2 weeks follow-up (week 6))
  • Assessment of physical activity(After 2 weeks follow-up (week 6))
  • Changes in intestinal function(After 2 weeks follow-up (week 6))
  • Changes in gastrointestinal symptoms(After 2 weeks follow-up (week 6))
  • Change in perceived stress levels(After 2 weeks follow-up (week 6))
  • Assessment of sleep quality(After 4 week consumption of the study product)
  • Assessment of physical activity(After 4 weeks consumption of study product)
  • Changes on health-related quality of life(After 4 weeks consumption of the study product)
  • Changes in quality of life(After 4 weeks consumption of the study product)
  • Changes in intestinal function(After 4 weeks consumption of the study product)
  • Changes in gastrointestinal symptoms(After 4 weeks consumption of the study product)
  • Assessment of sleep quality(After 2 weeks follow-up (week 6))
  • Assessment of physical activity(After 2 weeks follow-up (week 6))
  • Changes on health-related quality of life(After 2 weeks follow-up (week 6))
  • Changes in quality of life(After 2 weeks follow-up (week 6))
  • Changes in intestinal function(After 2 weeks follow-up (week 6))
  • Changes in gastrointestinal symptoms(After 2 weeks follow-up (week 6))
  • Change in perceived stress levels(After 2 weeks follow-up (week 6))

研究者

发起方
Synbiotec Srl
申办方类型
Industry
责任方
Sponsor

研究点 (2)

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