| CTRI Number |
CTRI/2025/09/094743 [Registered on: 15/09/2025] Trial Registered Prospectively |
| Last Modified On: |
13/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effects of aerobic and strength training on memory and body weight in overweight youth eating packaged foods |
|
Scientific Title of Study
|
Effects of combined aerobic and resistance training program on cognition and anthropometric parameters in overweight young adults consuming ultra-processed foods: A randomized controlled trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Surbhi Kaura |
| Designation |
Professor |
| Affiliation |
Galgotias University |
| Address |
Room B 320 Block B 3rd floor Department of physiotherapy Galgotias University Plot No.2 Sector 17A Yamuna
Expressway Greater Noida Gautam Buddh Nagar Uttar Pradesh India
Gautam Buddha Nagar
UTTAR PRADESH
203201
India |
| Phone |
8527389589 |
| Fax |
|
| Email |
surbhi.kaura@galgotiasuniversity.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Surbhi Kaura |
| Designation |
Professor |
| Affiliation |
Galgotias University |
| Address |
Room no B 302 3rd floor Department of physiotherapy Galgotias University Plot No.2 Sector 17A Yamuna
Expressway Greater Noida Gautam Buddh Nagar Uttar Pradesh India
Gautam Buddha Nagar
UTTAR PRADESH
203201
India |
| Phone |
8527389589 |
| Fax |
|
| Email |
surbhi.kaura@galgotiasuniversity.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Vaishali Jindal |
| Designation |
PG Student |
| Affiliation |
Galgotias University |
| Address |
OPD room no E003 Block E ground floor Department of physiotherapy Galgotias University Plot No.2 Sector 17A Yamuna
Expressway Greater Noida Gautam Buddh Nagar Uttar Pradesh India
Gautam Buddha Nagar
UTTAR PRADESH
203201
India |
| Phone |
9582393714 |
| Fax |
|
| Email |
vaishali.24smas2060007@galgotiasuniversity.ac.in |
|
|
Source of Monetary or Material Support
|
| OPD Physiotherapy E003 lab Galgotias university Gautam Budh Nagar Yamuna
Expressway UP 203201 India |
|
|
Primary Sponsor
|
| Name |
Galgotias University |
| Address |
Block B 3rd floor Galgotias University Plot No.2 Sector 17A Yamuna
Expressway Greater Noida Gautam Buddh Nagar Uttar Pradesh India
203201 |
| Type of Sponsor |
Other [University] |
|
|
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 Surbhi Kaura |
Galgotias University |
OPD room no E003 ground floor
Department of physiotherapy Galgotias University Plot No2 Sector 17A Yamuna
Expressway Greater Noida Gautam Buddh Nagar Uttar Pradesh India
Gautam Buddha Nagar
UTTAR PRADESH |
08527389589
surbhi.kaura@galgotiasuniversity.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Departmental Research Committee, Department of Physiotherapy, School of Allied Health Sciences, Galgotias university |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E660||Obesity due to excess calories, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Aerobic and Resistance exercise |
Participants will receive 4 weeks intervention where moderate aerobic Exercise is to be done for 30 min 3 days per week ensuring at least 48 hours between
sessions. And Resistance Training of 30 min for 2 days per week . it includes bodyweight exercises and dumbbells.this is done for 4 weeks. |
| Comparator Agent |
Group B
|
Participants will receive Conventional physical therapy like walking and stretches only for 5 days in a week for 4 weeks |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Both |
| Details |
BMI 25 to 30 kg per meter square
High UPF intake more than 50 percent
Pre hypertensive or prediabetic indicators or sleep or concentration problems |
|
| ExclusionCriteria |
| Details |
Diagnosed metabolic or psychiatric disorders
Cardiovascular or orthopaedic issues limiting exercise
Already enrolled in structured exercise programs |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Trail Making Test and The Rey Auditory Verbal Learning Test |
Baseline and 4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Anthropometrics BMI weight waist circumference and body fat percent |
Baseline and 4weeks |
|
|
Target Sample Size
|
Total Sample Size="58"
Sample Size from India="58"
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)
|
02/10/2025 |
| 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="8"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Title: Effects of Combined Aerobic and Resistance Training on Cognition and Anthropometric Parameters in Overweight Young Adults Consuming Ultra-Processed Foods: A Randomized Controlled Trial
Background: The global rise in obesity, particularly among young adults, is closely linked to increased consumption of ultra-processed foods (UPFs). UPFs are associated with adverse metabolic outcomes and cognitive impairments. While aerobic and resistance exercises individually offer health benefits, their combined effects on cognition and anthropometric parameters in overweight individuals consuming UPF-rich diets remain underexplored.
Objective: To evaluate the impact of a 4-week combined moderate-intensity aerobic and resistance training program on cognitive function and anthropometric measures in overweight young adults with high UPF intake.
Methods: This randomized controlled trial will enroll overweight participants aged 18–25 years with high UPF consumption. Participants will be randomly assigned to either an exercise intervention group or a control group. The intervention group will engage in supervised aerobic and resistance training sessions five times per week for four weeks. Cognitive functions, including memory and executive processing, will be assessed using standardized neuropsychological tests. Anthropometric measurements—body weight, BMI, waist circumference, and body fat percentage—will be recorded pre- and post-intervention.
|