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Trial record 18 of 1925 for:    (elderly OR senior) AND exercise AND (woman OR women OR female)

Dietary Choice in Active Older Adult Women

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ClinicalTrials.gov Identifier: NCT03082781
Recruitment Status : Completed
First Posted : March 17, 2017
Last Update Posted : March 21, 2017
Sponsor:
Information provided by (Responsible Party):
Mohammadreza Rezaeipour, MD, PhD, University of Sistan and Baluchestan

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.

Condition or disease Intervention/treatment Phase
Exercise Addiction Diet Habit Obesity Overweight Weight Loss Dietary Supplement: NCDsport Dietary Supplement: LCDsport Not Applicable

Detailed Description:

Background: Negative-calorie diet is among the popular dieting guides for weight loss; however, there is still little knowledge about this method.

Objectives: 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.

Material and Methods: Participants included sedentary women (age 45-75 years) with overweight or obesity (n=111). They were randomly divided into two groups including negative calorie diet with exercise, and low-calorie diet with exercise. Of all 111 participants, 90 persons completed the treatment. The weight assessment parameters including change in weight and body composition, blood sample tests were performed pre- and three month post-intervention.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 66 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: 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
Actual Study Start Date : October 10, 2012
Actual Primary Completion Date : June 20, 2013
Actual Study Completion Date : August 15, 2013

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Study group I
Study 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.
Dietary Supplement: NCDsport
Negative Calorie Diet supplemented with exercise
Other Name: group I

Experimental: Study group II
Study 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.
Dietary Supplement: LCDsport
Low-Calorie diet with exercise
Other Name: group II




Primary Outcome Measures :
  1. Weight [ Time Frame: Baseline ]
    assessed in kg

  2. Total cholesterol (Total-C) [ Time Frame: Baseline ]
    assessed in mg/dl

  3. High-density lipoprotein -cholesterol (HDL-C) [ Time Frame: Baseline ]
    assessed in mg/dl

  4. Low-density lipoprotein -cholesterol (LDL-C) [ Time Frame: Baseline ]
    assessed in mg/dl

  5. Triglycerides (TG) [ Time Frame: Baseline ]
    assessed in mg/dl


Secondary Outcome Measures :
  1. Weight [ Time Frame: 3-month ]
    assessed in kg

  2. Total cholesterol (Total-C) [ Time Frame: 3-month ]
    assessed in mg/dl

  3. High-density lipoprotein -cholesterol (HDL-C) [ Time Frame: 3-month ]
    assessed in mg/dl

  4. Low-density lipoprotein -cholesterol (LDL-C) [ Time Frame: 3-month ]
    assessed in mg/dl



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Ages Eligible for Study:   45 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Participants were 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.
Accepts Healthy Volunteers:   Yes
Criteria

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.


Responsible Party: Mohammadreza Rezaeipour, MD, PhD, Asst. Prof. of sports medicine (sports injury and corrective movement), University of Sistan and Baluchestan
ClinicalTrials.gov Identifier: NCT03082781     History of Changes
Other Study ID Numbers: No Grant 5
First Posted: March 17, 2017    Key Record Dates
Last Update Posted: March 21, 2017
Last Verified: March 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Mohammadreza Rezaeipour, MD, PhD, University of Sistan and Baluchestan:
Diet
Exercise
Obesity
Overweight
Weight loss

Additional relevant MeSH terms:
Overweight
Weight Loss
Body Weight
Signs and Symptoms
Body Weight Changes