- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04802525
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
March 15, 2021 updated by: Marwa Eid, Cairo University
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
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
42
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Cairo, Egypt, 2011
- Marwa Eid
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
30 years to 50 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Moderate-intensity aerobic exercise training without dietary control group
|
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
|
Experimental: Low-fat diet program without exercise intervention group
|
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
|
Experimental: Moderate-intensity aerobic exercise training plus a low-fat diet program group
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Body Mass Index
Time Frame: 10 weeks
|
The height and weight were assessed using an electronic digital scale and consequently BMI was calculated
|
10 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 10, 2019
Primary Completion (Actual)
January 2, 2020
Study Completion (Actual)
January 15, 2020
Study Registration Dates
First Submitted
March 15, 2021
First Submitted That Met QC Criteria
March 15, 2021
First Posted (Actual)
March 17, 2021
Study Record Updates
Last Update Posted (Actual)
March 17, 2021
Last Update Submitted That Met QC Criteria
March 15, 2021
Last Verified
March 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- obesity 2
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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