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Clinical Trials/NCT03066882
NCT03066882CompletedNot Applicable

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

P.L.Shupik National Medical Academy of Post-Graduate Education0 sites37 target enrollmentStarted: May 10, 2012Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
37
Primary Endpoint
Weight

Study Overview

Brief 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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Supportive Care
Masking
None

Eligibility Criteria

Ages
45 Years to 75 Years (Adult, Older Adult)
Sex
Female
Accepts Healthy Volunteers
Yes

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.

Arms & Interventions

Study group I

Experimental

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.

Intervention: NCD (Dietary Supplement)

Study group II

Experimental

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.

Intervention: LCD (Dietary Supplement)

Outcomes

Primary Outcomes

Weight

Time Frame: pre-study

assessed in kg

Total cholesterol (Total-C)

Time Frame: pre-study

assessed in mg/dl

High-density lipoprotein -cholesterol (HDL-C)

Time Frame: pre-study

assessed in mg/dl

Low-density lipoprotein -cholesterol (LDL-C)

Time Frame: pre-study

assessed in mg/dl

Triglycerides (TG)

Time Frame: pre-study

assessed in mg/dl

Secondary Outcomes

  • Total cholesterol (Total-C)(3-month)
  • Weight(3-month)
  • High-density lipoprotein -cholesterol (HDL-C)(3-month)
  • Low-density lipoprotein -cholesterol (LDL-C)(3-month)

Investigators

Sponsor
P.L.Shupik National Medical Academy of Post-Graduate Education
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Mohammadreza Rezaeipour, MD, PhD

Assistant professor of sports medicine (sports injury and corrective movement)

University of Sistan and Baluchestan

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