UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052163 |
|---|---|
| Receipt number | R000059533 |
| Scientific Title | Effects of Nutritional Counselling on the Academic Stress, Inflammatory Biomarkers and Quality of Life in University Students: A Single Blinded Open Randomized Trail |
| Date of disclosure of the study information | 2023/09/10 |
| Last modified on | 2025/02/09 21:20:23 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Effects of Nutritional Counselling on the Academic Stress, Inflammatory
Biomarkers and Quality of Life in University Students: A Single Blinded Open
Randomized Trail
Acronym
Nutritional Counselling and Academic Stress
Scientific Title
Effects of Nutritional Counselling on the Academic Stress, Inflammatory
Biomarkers and Quality of Life in University Students: A Single Blinded Open
Randomized Trail
Scientific Title:Acronym
Nutritional Counselling and Academic Stress
Region
| Asia(except Japan) |
Condition
Condition
Nutritional Counselling and Academic Stress
Classification by specialty
| Endocrinology and Metabolism | Rehabilitation medicine | Nursing |
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The overall aim of the present work is to investigate the effects of dietary counselling on stress in the university students
Basic objectives2
Others
Basic objectives -Others
1. To test the effects of adherence to the Mediterranean diet on dietary inflammatory index
2. To determine whether changes in CRP and IL6 are correlated with adherence to the Mediterranean diet
3. To see if there is a connection between stress symptoms and changes in CRP and IL6.
4. To determine the connection between changes in health-related quality of life and adherence to the Mediterranean diet.
Trial characteristics_1
Others
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
stress related Inflammatory biomarkers (CRP)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Food |
Interventions/Control_1
intervention/control_2
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 40 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. between the ages of 18 and above;
2. Ready to comprehend and give informed assent;
3. Having an AS diagnosed according to the International Classification of Diseases.
4. biomarkers of inflammation that are elevated (CRP 3 mg/l or IL6 1.8pg/ml);
5. able to eat a Mediterranean diet without having any allergies, intolerances, or physical limitations;
treated for at least four weeks with the initial antidepressant prescribed.
Key exclusion criteria
1. diagnosis of cancer, thyroid dysfunction, or autoimmune diseases
2. diagnosis of eating disorders, substance abuse disorders, bipolar disorder, or psychotic disorders;
3. reporting an infection two weeks prior to the collection of the blood sample;
4. pregnancy or breastfeeding;
5. medication with glucocorticoids;
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Iftikhar |
| Middle name | |
| Last name | Alam |
Organization
Bacha khan University Charsadda, Pakistan
Division name
Human Nutrition and Dietetics
Zip code
25000
Address
Bacha Khan University Charsadda, Pakistan
TEL
00923455104041
iftikharalam@bkuc.edu.pk
Public contact
Name of contact person
| 1st name | Iftikhar |
| Middle name | |
| Last name | Alam |
Organization
BKUC
Division name
Human Nutrition and Dietetics
Zip code
25000
Address
Bacha Khan University Charsadda, Pakistan
TEL
00923455104041
Homepage URL
iftikharalam@bkuc.edu.pk
Sponsor or person
Institute
Bacha Khan University, Charsadda, Pakistan
Institute
Department
Personal name
Funding Source
Organization
Bacha Khan University, Charsadda, Pakistan
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Bacha Khan University, Charsadda, Pakistan
Address
Bacha Khan University, Charsadda, Pakistan
Tel
00923455104041
iftikharalam@aup.edu.pk
Secondary IDs
Secondary IDs
YES
Study ID_1
001
Org. issuing International ID_1
Bacha Khan University, Charsadda, Pakistan
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 09 | Month | 10 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
200
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2023 | Year | 08 | Month | 01 | Day |
Date of IRB
| 2023 | Year | 08 | Month | 01 | Day |
Anticipated trial start date
| 2023 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 09 | Month | 10 | Day |
Last modified on
| 2025 | Year | 02 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059533
