| CTRI Number |
CTRI/2022/05/042578 [Registered on: 17/05/2022] Trial Registered Prospectively |
| Last Modified On: |
12/05/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Dietary patterns and sleep quality of middle age in the Gujarati community. |
|
Scientific Title of Study
|
Assessment of dietary pattern and sleep quality of middle age in the Gujarati community. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Hiral Patel |
| Designation |
Student |
| Affiliation |
Dr. BMN College of Home Science |
| Address |
338, Rafi Ahmed Kidwai Rd, Matunga, Mumbai, Maharashtra
Mumbai
MAHARASHTRA
400019
India |
| Phone |
7620995573 |
| Fax |
|
| Email |
hiralpatel61096@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rekha Battalwar |
| Designation |
Associate Professor |
| Affiliation |
Sir Vithaldas Thackersey College of Home Science |
| Address |
Food, Nutrition and Dietetics Department, Sir Vithaldas Thackersay College Of Home Science (autonomous) SNDT Womens University, Juhu, Santacruz (W), Mumbai
Mumbai
MAHARASHTRA
400049
India |
| Phone |
9820286174 |
| Fax |
|
| Email |
drrekhab12@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Hiral Patel |
| Designation |
Student |
| Affiliation |
Dr. BMN College of Home Science |
| Address |
338, Rafi Ahmed Kidwai Rd, Matunga, Mumbai, Maharashtra
Mumbai
MAHARASHTRA
400019
India |
| Phone |
7620995573 |
| Fax |
|
| Email |
hiralpatel61096@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr BMN College of Home Science |
|
|
Primary Sponsor
|
| Name |
Not applicable |
| Address |
Not applicable |
| Type of Sponsor |
Other [Not applicable ] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| HIRAL PATEL |
Dr. BMN College of Home Science |
338, Rafi Ahmed Kidwai Rd, Matunga, Mumbai, Maharashtra 400019
Aurangabad
MAHARASHTRA |
7620995573
hiralpatel61096@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SEVA MANDAL EDUCATION SOCIETYS INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
NOT APPLICABLE |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Both genders (male & female), middle-age group (40-60yrs of age), Gujarati.
|
|
| ExclusionCriteria |
| Details |
pregnant women, lactating women, blind people, critical illnesses (cancer, liver failure, etc.) |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
There may be no correlation between dietary patterns and sleep quality of the middle age group in the Gujarati community.
|
4-months
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
30/05/2022 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="4"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Sleep plays an important role in brain function and human physiology including metabolism, appetite regulation, immunity as well as hormonal and cardiovascular systems. As people age, sleep quality declines. (1) Over recent decades, dietary patterns have changed with more frequent eating events over a longer period throughout the day. Several studies reported an association between skipping breakfast and CVD, type 2 diabetes, and obesity. (3) Recently, dietary intake and sleep have gained much attention to understanding dietary factors influencing sleep. Eg. Amino acid and tryptophan-rich food like milk improve sleep. Melatonin is a well-recognized sleep inducer that conveys information about the daily cycle of light and darkness to the body. (9) Some research demonstrated a high concentration of melatonin and serotonin ( sleep-promoting hormone ) eg. Cherries improve sleep duration and quality. Some people experience poor quality of sleep with late-night use of technology and work. (2,5,7) Greater risk of overweight and obesity is seen with consuming a higher percentage of daily energy intake during the evening and night time. (3) Studies have reported that higher energy intake especially from fat and snacks is linked with short sleepers (sleep <7 h/night) than than of normal sleepers. (4) It has been reported that a higher intake of fruits, vegetables, and legumes is linked with faster sleep onset. (6,7) worse sleep was associated with a higher intake of processed and free-sugar rich foods. (8) Caffeine, a component present in coffee and tea causes a decrease in total sleep time and quality. More arousals during the night are associated with the consumption of a higher saturated fat intake during the day. (9) Poor quality of sleep is a complex problem in the global population leading to a decrease in quality of life. Fewer studies are conducted to know changes in dietary patterns and their effect on sleep quality. Thus, this study will help us understand the relationship between dietary patterns and sleep quality.
|