MenNCT03082794
Dietary Effects on Weight Loss and Lipid Profile in Sedentary Men
A study testing NCD and LCD in people with Men and Life Style, run by P.L.Shupik National Medical Academy of Post-Graduate Education.
Trial summary
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 in men. Read more about this study
- Who is it for?
- Ages 45 to 75 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Men, Life Style, Lipid Metabolism Disorders
- What is being tested?
- NCD and LCD
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- No sites listed yet
- Study dates
- 20 Feb 2011to 27 Dec 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 75 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Non-smokers
- Weight-stable (± 2 kg, for more than one year)
- No history of regular exercise (in at least three months before the study).
Who cannot join
- History of medical disorders (CVD and other such as diabetes, depression, eating disorders, chronic medications, kidney disease, cancer, food allergies or intolerances to items used in meals, abnormality in thyroid or Electrocardiograph
- History of anti-obesity medication or weight loss drugs or dietary supplementations for weight control.
About this study
Official title: Investigating the Effects of Negative Calorie Diet Compared With Low-Calorie Diet on Weigh Loss and Lipid Profile in Sedentary Overweight/Obese Middle-Aged and Older Men
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 in men.
- Conditions
- Men, Life Style, Lipid Metabolism Disorders, Obesity, Overweight
- Being tested
- NCD, LCD
- Keywords
- Dietary Formulations, Lifestyle, Obesity, Overweight, weight loss
- Medical subject headings
- Multiple Endocrine Neoplasia Type 1, Lipid Metabolism Disorders, Obesity, Overweight, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NCDDietary supplement
Also called group I
Negative Calorie Diet
LCDDietary supplement
Also called group II
Low Calorie Diet
| Study group | Role | What they receive |
|---|---|---|
| Study group I | Experimental | Study group I (53 participants) received the NCD (details of diet: 15% protein, 75% carbohydrates, 10% fat). Both groups had 15% caloric restriction from their maintenance energy requirements. Receives: Dietary Supplement: NCD |
| Study group II | Experimental | Study group II (51 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. Receives: Dietary Supplement: LCD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight
assessed in kg
Measured: Baseline
Total cholesterol (Total-C)
assessed in mg/dl
Measured: Baseline
High-density lipoprotein -cholesterol (HDL-C)
assessed in mg/dl
Measured: Baseline
Low-density lipoprotein -cholesterol (LDL-C)
assessed in mg/dl
Measured: Baseline
Triglycerides (TG)
assessed in mg/dl
Measured: Baseline
Secondary outcomes (4)
Weight
assessed in kg
Measured: 3-month
Total cholesterol (Total-C)
assessed in mg/dl
Measured: 3-month
High-density lipoprotein -cholesterol (HDL-C)
assessed in mg/dl
Measured: 3-month
Low-density lipoprotein -cholesterol (LDL-C)
assessed in mg/dl
Measured: 3-month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2017
- Study start20 Feb 2011
- Primary completion20 Sep 2012
- Study completion27 Dec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- P.L.Shupik National Medical Academy of Post-Graduate Education
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammadreza Rezaeipour, MD, PhD, University of Sistan and Baluchestan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03082794
- Sponsor's protocol ID
- no Grant 4
- Status last verified
- Mar 2017
- First submitted
- 4 Mar 2017
- Last updated
- 21 Mar 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Effects of Negative Calorie Diet Compared With Low-Calorie Diet on Weigh Loss and Lipid Profile in Sedentary Overweight/Obese Middle-Aged and Older Men
- ClinicalTrials.gov ID
- NCT03082794
- Acronym / sponsor ID
- no Grant 4
- Conditions
- Men, Life Style, Lipid Metabolism Disorders, Obesity, Overweight
- Keywords
- Dietary Formulations, Lifestyle, Obesity, Overweight, weight loss
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- P.L.Shupik National Medical Academy of Post-Graduate EducationUniversity, hospital or other
- Study start
- 20 Feb 2011 (actual)
- Primary completion
- 20 Sep 2012 (actual)
- Study completion
- 27 Dec 2012 (actual)
- First posted
- 17 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 in men.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study group I | Experimental | Dietary Supplement: NCDStudy group I (53 participants) received the NCD (details of diet: 15% protein, 75% carbohydrates, 10% fat). Both groups had 15% caloric restriction from their maintenance energy requirements. |
| Study group II | Experimental | Dietary Supplement: LCDStudy group II (51 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. |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Non-smokers
- Weight-stable (± 2 kg, for more than one year)
- No history of regular exercise (in at least three months before the study).
Key exclusion criteria (2 listed)
- History of medical disorders (CVD and other such as diabetes, depression, eating disorders, chronic medications, kidney disease, cancer, food allergies or intolerances to items used in meals, abnormality in thyroid or Electrocardiograph
- History of anti-obesity medication or weight loss drugs or dietary supplementations for weight control.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NCDAlso: group INegative Calorie Diet | Dietary supplement | Study group I |
| LCDAlso: group IILow Calorie Diet | Dietary supplement | Study group II |
Primary outcome
Weight
Time frame: Baseline
assessed in kg
Total cholesterol (Total-C)
Time frame: Baseline
assessed in mg/dl
High-density lipoprotein -cholesterol (HDL-C)
Time frame: Baseline
assessed in mg/dl
Low-density lipoprotein -cholesterol (LDL-C)
Time frame: Baseline
assessed in mg/dl
Triglycerides (TG)
Time frame: Baseline
assessed in mg/dl
4 secondary outcomes
Weight
Time frame: 3-month
Total cholesterol (Total-C)
Time frame: 3-month
High-density lipoprotein -cholesterol (HDL-C)
Time frame: 3-month
Low-density lipoprotein -cholesterol (LDL-C)
Time frame: 3-month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing NCD and LCD in people with Men and Life Style, run by P.L.Shupik National Medical Academy of Post-Graduate Education.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weight (time frame: Baseline). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2017.