Back to resultsA Low-fat Diet Combined With Moderate-intensity Aerobic Exercise Versus Low-fat Diet, Aerobic Exercise Alone on Dyslipidemia and Depression Status in Obese Patients
Primary Purpose
Dyslipidemias
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Moderate-intensity aerobic exercise training
Sponsored by
About this trial
This is an interventional treatment trial for Dyslipidemias
Eligibility Criteria
Inclusion Criteria:
- age of 30-50 years
- clinical diagnosis with obesity (BMI˃30)
- mild to moderate depression
- impaired blood lipids
- no use of medications last 6-12 months
- no smoking
Exclusion Criteria:
- neuromuscular, endocrinal, musculoskeletal, cardiovascular disorders
- severe depression
- patients using medications of dyslipidemia, depression, or obesity last 6-12 months.
Sites / Locations
- Marwa Eid
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Moderate-intensity aerobic exercise training without dietary control group
Low-fat diet program without exercise intervention group
Moderate-intensity aerobic exercise training plus a low-fat diet program group
Arm Description
Outcomes
Primary Outcome Measures
Body Mass Index
The height and weight were assessed using an electronic digital scale and consequently BMI was calculated
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04802525
Brief Title
A Low-fat Diet Combined With Moderate-intensity Aerobic Exercise Versus Low-fat Diet, Aerobic Exercise Alone on Dyslipidemia and Depression Status in Obese Patients
Official Title
A Low-fat Diet Combined With Moderate-intensity Aerobic Exercise is More Effective Than a Low-fat Diet or Aerobic Exercise Alone on Dyslipidemia and Depression Status in Obese Patients
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
October 10, 2019 (Actual)
Primary Completion Date
January 2, 2020 (Actual)
Study Completion Date
January 15, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
It was defined that exercise and dietary interventions are used to control dyslipidemia and depression in obese individuals, whilst rare investigations have examined the concurrent effects of a low-fat diet and moderate-intensity aerobic exercise training (MIAET) on dyslipidemia and depression in obese patients. Hence, we assessed the potential influences of a low-fat diet combined with MIAET on blood lipids and depression in those individuals.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dyslipidemias
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
42 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Moderate-intensity aerobic exercise training without dietary control group
Arm Type
Experimental
Arm Title
Low-fat diet program without exercise intervention group
Arm Type
Experimental
Arm Title
Moderate-intensity aerobic exercise training plus a low-fat diet program group
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Moderate-intensity aerobic exercise training
Intervention Description
The first group has received Moderate-intensity aerobic exercise training without dietary control, the second group has received a low-fat diet program without exercise intervention, and the third group has received Moderate-intensity aerobic exercise training plus a low-fat diet program for 10 consecutive weeks
Primary Outcome Measure Information:
Title
Body Mass Index
Description
The height and weight were assessed using an electronic digital scale and consequently BMI was calculated
Time Frame
10 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
age of 30-50 years
clinical diagnosis with obesity (BMI˃30)
mild to moderate depression
impaired blood lipids
no use of medications last 6-12 months
no smoking
Exclusion Criteria:
neuromuscular, endocrinal, musculoskeletal, cardiovascular disorders
severe depression
patients using medications of dyslipidemia, depression, or obesity last 6-12 months.
Facility Information:
Facility Name
Marwa Eid
City
Cairo
ZIP/Postal Code
2011
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Low-fat Diet Combined With Moderate-intensity Aerobic Exercise Versus Low-fat Diet, Aerobic Exercise Alone on Dyslipidemia and Depression Status in Obese Patients
We'll reach out to this number within 24 hrs