| CTRI Number |
CTRI/2023/12/060787 [Registered on: 26/12/2023] Trial Registered Prospectively |
| Last Modified On: |
30/11/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
The outcome of eating protein-rich food on oral health in physically fit individuals |
|
Scientific Title of Study
|
“Effects of protein supplements on oral health in
Athletesâ€â€“ A cross-sectional study
|
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Swathi Vathsa |
| Designation |
Post Graduate |
| Affiliation |
JSS Dental College and Hospital |
| Address |
Department of Periodontology
Room no: 9
JSS Dental College and Hospital
Bannimantap, Bangalore Mysore Road
Mysore
Department of Periodontology
Room no: 9
JSS Dental College and Hospital
Bannimantap, Bangalore Mysore Road
Mysore
Mysore
KARNATAKA
570015
India |
| Phone |
9483466086 |
| Fax |
|
| Email |
swavathsa@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vidya Priyadharshini |
| Designation |
Reader |
| Affiliation |
JSS Dental College and Hospital |
| Address |
Department of Periodontology
Room no: 9
JSS Dental College and Hospital
Bannimantap, Bangalore Mysore Road
Mysore
Department of Periodontology
Room No: 9
JSS Dental College and Hospital
Bannimantap, Bangalore Mysore Road
Mysore
Mysore
KARNATAKA
570015
India |
| Phone |
9739029250 |
| Fax |
|
| Email |
drvidyapd77@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Swathi Vathsa |
| Designation |
Post Graduate |
| Affiliation |
JSS Dental College and Hospital |
| Address |
Department of Periodontology
Room No: 9
JSS Dental College and Hospital
Bannimantap, Bangalore Mysore Road
Mysore
Department of Periodontology
Room No: 9
JSS Dental College and Hospital
Bannimantap, Bangalore Mysore Road
Mysore
Mysore
KARNATAKA
570015
India |
| Phone |
9483466086 |
| Fax |
|
| Email |
swavathsa@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Periodontology
JSS Dental College and Hospital |
|
|
Primary Sponsor
|
| Name |
JSS Dental College and Hospital |
| Address |
Bannimantap, Bangalore- Mysore road
Mysore |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Dr Swathi Vathsa |
Mysore ovals ground |
K.G Koppal, Kajjihundi, Mysuru, Karnataka 570005
Mysore
KARNATAKA |
9483466086
swavathsa@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| JSS DENTAL COLLEGE AND HOSPITAL INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy Athletes |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
39.00 Year(s) |
| Gender |
Male |
| Details |
Athletes remaining in training and using protein supplements regularly for 1 year or more
Individuals using the most commonly used brands of supplements |
|
| ExclusionCriteria |
| Details |
Athletes using other types of supplements such as steroids, drugs, or substances
Smokers and alcoholics |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To determine the beneficial / detrimental effects of protein supplements on oral health of
athletes
To evaluate the effects of consumption of protein supplements on dental health by determining caries index
To evaluate the effects of consumption of protein supplements on periodontal health
status taking into consideration the plaque scores, gingival scores and periodontal
disease index scores
To analyze the cumulative data obtained and validate the effectiveness of protein
supplements |
To determine the beneficial / detrimental effects of protein supplements on oral health of
athletes
To evaluate the effects of consumption of protein supplements on dental health by determining caries index
To evaluate the effects of consumption of protein supplements on periodontal health
status taking into consideration the plaque scores, gingival scores and periodontal
disease index scores
To analyze the cumulative data obtained and validate the effectiveness of protein
supplements |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To evaluate the effects of consumption of protein supplements on dental health by
determining caries index
2. To evaluate the effects of consumption of protein supplements on periodontal health
status taking into consideration the plaque scores, gingival scores and periodontal
disease index scores
3. To analyze the cumulative data obtained and validate the effectiveness of protein
supplements |
single point |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
30/12/2023 |
| 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="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Physical activity along with consumption of protein supplements to procure health benefits has been trending globally. Proteins play an essential role in human nutrition throughout life, supporting growth in infancy, maintaining and developing a normal nervous system along with sustaining muscle mass and physical capabilities. The recommended daily dose of protein intake for normal persons is 0.83 g protein/kg body weight per day, which represents around 10–12% of total energy intake. Physiological protein requirements may be elevated in athletes in order to maintain adequate protein synthesis and energy production. The need increases along with the increasing intensity and duration of an athletic performance. A recent position statement from the Academy of Nutrition and Dietetics, Dieticians of America, and the American College of Sports Medicine suggests that physically active individuals should consume 1.2 to 2.0 grams of protein per kilogram of body weight. Apart from various health benefits, protein supplements have certain side effects such as presence of acne, modification of microbiota, cardiovascular, hepatic, renal, and psychiatric diseases. The adverse effect of protein supplements on oral health will lead to increased risk of developing dental caries, plaque accumulation and gingivitis. Among London Olympic game athletes, greater number of participants showed signs of gingivitis and increased incidence of dental caries. On the contrary, in another study, protein supplements was associated with decreased plaque and gingival scores. Hence, the purpose of this study is to find the effect of protein supplements on oral health of athletes in Mysore |