- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03066882
Dietary Effects on Weight Loss and Lipid Profile in Sedentary Women
February 23, 2017 updated by: Mohammadreza Rezaeipour, MD, PhD, P.L.Shupik National Medical Academy of Post-Graduate Education
Comparison Effects of Negative Calorie Diet and Low-calorie Diet on Weight Loss and Lipid Profile in Sedentary Overweight/Obese Middle-aged and Older Women
Negative-calorie diet is among the popular dieting guides for weight loss; however, there is still little knowledge about this method.
The present study aimed to determine the effects of negative-calorie diet on weight loss and lipid profile, and to compare its efficiency with low-calorie diet.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
37
Phase
- Not Applicable
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
43 years to 73 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Non-smokers and weight-stable (± 2 kg, for more than one year) with no history of regular exercise in at least three months before the study.
Exclusion Criteria:
- History of CVD and other disorders such as diabetes, depression, eating disorders, chronic medications, kidney disease, cancer, food allergies or intolerances to items used in meals.
- Subjects with abnormality in thyroid or Electrocardiograph, any history of anti-obesity medication or weight loss drugs or dietary supplementations for weight control.
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: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Study group I
Study group I (19 participants) received the NCD (details of diet: 15% protein, 75% carbohydrates, 10% fat).
Both groups had 15% caloric restriction from their maintenance energy requirements.
|
negative calorie diet
Other Names:
|
Experimental: Study group II
Study group II (18 participants) received the LCD or healthy weight maintenance diet (details of diet: 15% protein, 55% carbohydrates, 30% fat).Both groups had 15% caloric restriction from their maintenance energy requirements.
|
low calorie diet
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Weight
Time Frame: pre-study
|
assessed in kg
|
pre-study
|
Total cholesterol (Total-C)
Time Frame: pre-study
|
assessed in mg/dl
|
pre-study
|
High-density lipoprotein -cholesterol (HDL-C)
Time Frame: pre-study
|
assessed in mg/dl
|
pre-study
|
Low-density lipoprotein -cholesterol (LDL-C)
Time Frame: pre-study
|
assessed in mg/dl
|
pre-study
|
Triglycerides (TG)
Time Frame: pre-study
|
assessed in mg/dl
|
pre-study
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Weight
Time Frame: 3-month
|
assessed in kg
|
3-month
|
Total cholesterol (Total-C)
Time Frame: 3-month
|
assessed in mg/dl
|
3-month
|
High-density lipoprotein -cholesterol (HDL-C)
Time Frame: 3-month
|
assessed in mg/dl
|
3-month
|
Low-density lipoprotein -cholesterol (LDL-C)
Time Frame: 3-month
|
assessed in mg/dl
|
3-month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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)
May 10, 2012
Primary Completion (Actual)
September 20, 2015
Study Completion (Actual)
October 30, 2016
Study Registration Dates
First Submitted
February 17, 2017
First Submitted That Met QC Criteria
February 23, 2017
First Posted (Actual)
March 1, 2017
Study Record Updates
Last Update Posted (Actual)
March 1, 2017
Last Update Submitted That Met QC Criteria
February 23, 2017
Last Verified
February 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- no grant 3
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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