Dietary Choice in Active Older Adult Women
A Comparative Assessment of Weight Loss and Anti-lipid Effects of Negative Calorie Diet and Low-calorie Diet in Overweight/Obese Middle-aged and Older Women Under Exercise Condition
1 other identifier
interventional
66
0 countries
N/A
Brief Summary
The present study aimed to determine the effects of negative-calorie diet supplemented with exercise, on weight loss and lipid profile, and to compare its efficiency with low-calorie diet with exercise among elderly adult women with abnormal weight gain.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Oct 2012
Shorter than P25 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 10, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 20, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
August 15, 2013
CompletedFirst Submitted
Initial submission to the registry
March 5, 2017
CompletedFirst Posted
Study publicly available on registry
March 17, 2017
CompletedMarch 21, 2017
March 1, 2017
8 months
March 5, 2017
March 17, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (5)
Weight
assessed in kg
Baseline
Total cholesterol (Total-C)
assessed in mg/dl
Baseline
High-density lipoprotein -cholesterol (HDL-C)
assessed in mg/dl
Baseline
Low-density lipoprotein -cholesterol (LDL-C)
assessed in mg/dl
Baseline
Triglycerides (TG)
assessed in mg/dl
Baseline
Secondary Outcomes (4)
Weight
3-month
Total cholesterol (Total-C)
3-month
High-density lipoprotein -cholesterol (HDL-C)
3-month
Low-density lipoprotein -cholesterol (LDL-C)
3-month
Study Arms (2)
Study group I
EXPERIMENTALStudy group I (57 participants) received the NCD with exercise (NCDsport).This groups had 5% caloric restriction from their maintenance energy requirements and 10% increase in energy expenditure through structured regular exercise.
Study group II
EXPERIMENTALStudy group II (54 participants) received the low-calorie diet with exercise (LCDsport). This groups had 5% caloric restriction from their maintenance energy requirements and 10% increase in energy expenditure through structured regular exercise.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Asst. Prof. of sports medicine (sports injury and corrective movement)
Study Record Dates
First Submitted
March 5, 2017
First Posted
March 17, 2017
Study Start
October 10, 2012
Primary Completion
June 20, 2013
Study Completion
August 15, 2013
Last Updated
March 21, 2017
Record last verified: 2017-03