Dietary Effects on Weight Loss and Lipid Profile in Sedentary Men

March 17, 2017 updated by: Mohammadreza Rezaeipour, MD, PhD, P.L.Shupik National Medical Academy of Post-Graduate Education

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

104

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

45 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Non-smokers
  • Weight-stable (± 2 kg, for more than one year)
  • No history of regular exercise (in at least three months before the study).

Exclusion Criteria:

  • 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.

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 (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.
Dietary supplement: NCD
Negative Calorie Diet
Other Names:
  • group I
Experimental: Study group II
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.
Dietary supplement: LCD
Low Calorie Diet
Other Names:
  • group II

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Weight
Time Frame: Baseline
assessed in kg
Baseline
Total cholesterol (Total-C)
Time Frame: Baseline
assessed in mg/dl
Baseline
High-density lipoprotein -cholesterol (HDL-C)
Time Frame: Baseline
assessed in mg/dl
Baseline
Low-density lipoprotein -cholesterol (LDL-C)
Time Frame: Baseline
assessed in mg/dl
Baseline
Triglycerides (TG)
Time Frame: Baseline
assessed in mg/dl
Baseline

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.

Sponsor

P.L.Shupik National Medical Academy of Post-Graduate Education

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)

February 20, 2011

Primary Completion (Actual)

September 20, 2012

Study Completion (Actual)

December 27, 2012

Study Registration Dates

First Submitted

March 4, 2017

First Submitted That Met QC Criteria

March 12, 2017

First Posted (Actual)

March 17, 2017

Study Record Updates

Last Update Posted (Actual)

March 21, 2017

Last Update Submitted That Met QC Criteria

March 17, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • no Grant 4

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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