Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06612164
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-09-23
Brief Title:
Effects of Kefir Consumption on Health Outcomes Gastrointestinal System Immunity Biochemical Parameters Body Composition Sleep Quality and Mental Well Being in Healthy Adults
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Effects of Kefir Consumption on Health Outcomes Gastrointestinal System Immunity Biochemical Parameters Body Composition Sleep Quality and Mental Well Being in Healthy Adults
Status:
COMPLETED
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
KefirCons
Brief Summary:
The goal of this clinical trial is to evaluate the effects of the administration of kefir on gastrointestinal system mental health biochemical parameters immunity and inflammation processes as well as the sleep quality elucidating the possible health effects of kefir consumption in healthy adults The main questions it aims to answer are
1 Will be better the gastrointestinal system symptoms severity of volunteers in the intervention group will be better compared to the control group
2 Will be better the mental health status of volunteers in the intervention group will be better compared to the control group
3 Will be better the biochemical parameters of volunteers in the intervention group will be better compared to the control group
4 Will be better the immunity and inflammation processes of volunteers in the intervention group will be better compared to the control group
The participants were asked to consume 250 mL of plain lactose-free kefir daily for 6 weeks Any particular time was not specified for kefir consumption Kefir consumption routine of participants was followed up by regular phone calls every week and evaluated by examining their consumption records Those who consumed less than 850 skipping kefir consumption maximum once a week of the planned kefir consumption during the study period were excluded from the study
1 Will be better the gastrointestinal system symptoms severity of volunteers in the intervention group will be better compared to the control group
2 Will be better the mental health status of volunteers in the intervention group will be better compared to the control group
3 Will be better the biochemical parameters of volunteers in the intervention group will be better compared to the control group
4 Will be better the immunity and inflammation processes of volunteers in the intervention group will be better compared to the control group
The participants were asked to consume 250 mL of plain lactose-free kefir daily for 6 weeks Any particular time was not specified for kefir consumption Kefir consumption routine of participants was followed up by regular phone calls every week and evaluated by examining their consumption records Those who consumed less than 850 skipping kefir consumption maximum once a week of the planned kefir consumption during the study period were excluded from the study
Detailed Description:
In order to evaluate the general characteristics history of diseases and nutritional behaviors a face-to-face questionnaire was conducted on all participants by the researchers The questionnaire form contained information about the demographic information age gender educational status marital status etc history of diseases diagnosed diseases drugs used etc basic nutritional habits number of major mealssnacks consumed in a day water consumption etc and anthropometric measurements body weight height body mass index waist circumference neck circumference In the intial pre-intervention and final post-intervention stages of the study anthropometric measurements of the participants were taken and body composition analysis was done In addition biochemical findings and 3-day food consumption records were taken in the intial pre-intervention and final post-intervention stages of the study Effects of kefir consumption on gastrointestinal system biochemical findings mental health immunity and inflammation sleep quality was evaluated by assessment of the relevant status of participants before and after kefir intervention and comparison with the control group Short Physical Activity Assessment Tool was used for evaluating physical activity levels of the participants mental health status by The Warwick-Edinburgh Mental Well-Being Scale WEMWBS Gastrointestinal system symptoms were evaluated by using the Gastrointestinal Symptom Rating Scale GSRS sleep quality by the Pittsburg Sleep Quality Index PSQI and diet quality by the Healthy Eating Index-2015 HEI-2015 Measurements were recorded prior to kefir intervention initial measurement and post kefir intervention final measurement for kefir and control groups
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None