The Effects Of Probiotics On Stress Among Healthy Adults From Umm Al-Qura University At Makkah

NCT ID: NCT06464484

Last Updated: 2024-06-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 85 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-26
• Study Completion Date: 2024-04-30

Brief Summary

The goal of this clinical trial is to study the effects of probiotic supplementation on stress levels and bowel habits in healthy Saudi adults for both males and females.

The main questions it aims to answer are:

Does probiotic supplementation decrease stress levels? Does probiotic supplementation improve bowel habits?

Researchers compared between the intervention group receiving probiotic supplements with high stress levels with a control group not receiving probiotics with high stress levels to see if probiotics decreases stress levels.

Detailed Description

Participants were required to

1. Attend a visit to the nutrition clinic at Umm AL-Qura University to assess for eligibility.

2. Eligible participants were asked to sign a consent form and anthropometrics, stress, bowel habits, food records and knowledge on probiotics were collected

3. Participants were randomized based on lottery based method to an interventional or control group

4. Intervention group received 30 capsules of probiotics (Lactobacillus rhamnosus GG, 6x10^9 cpu) to be taken once daily

5. After 30 days, all participants had to attend a second visit at the nutrition clinic at Umm Al-Qura University to assess stress levels, bowel habits and receive their incentives (discount voucher of restaurants).

Conditions

Stress; Constipation; Anthropometry; Bowel Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Experimental: cases

Consumed one probiotic for 30 days everyday with or without food. Dicoflor 60 probiotic supplements were provided that contained Lactobacillus rhamnosus GG (ATCC 53103) that contained 6x10\^9 colony forming units (cpu)) per capsule.

Group Type: EXPERIMENTAL

Probiotics (Lactobacillus rhamnosus GG (ATCC 53103)

Intervention Type: DIETARY_SUPPLEMENT

Already mentioned in arm/group descriptions

Controls

Had high stress levels but did not consume probiotics

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Probiotics (Lactobacillus rhamnosus GG (ATCC 53103)

Already mentioned in arm/group descriptions

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

Dicoflor 60

Eligibility Criteria

Inclusion Criteria

• Students at Umm Al-Qura University
• Age ≥ 18 years
• Healthy individuals
• Both genders
• Saudi nationality

Exclusion Criteria

• Diagnosed with chronic illness or/and psychiatric condition
• Consumption of medications or supplements in the previous 3 months
• Pregnant and breastfeeding
• Smoker

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Umm Al-Qura University

OTHER

Sponsor Role: lead

Responsible Party

Essra Noorwali

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Essra Noorwali, PhD

Role: PRINCIPAL_INVESTIGATOR

Umm Al-Qura University

Locations

Umm Al-Qura University

Mecca, , Saudi Arabia

Countries

Saudi Arabia

Other Identifiers

HAPO-02-K-012-2023-01-1414

Identifier Type: -

Identifier Source: org_study_id