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Completed

NCT Number: NCT03082807

Dietary Guide in Active Older Adult Men

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 men with abnormal weight gain.

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Key information

Conditions

Men Behavior Body Weight Body Weight Changes Congenital, Hereditary, and Neonatal Diseases and Abnormalities Diet Modification Endocrine Gland Neoplasms Endocrine System Diseases Genetic Diseases, Inborn Life Style Motor Activity Multiple Endocrine Neoplasia Multiple Endocrine Neoplasia Type 1 Neoplasms Neoplasms by Site Neoplasms, Multiple Primary Neoplastic Syndromes, Hereditary Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Sedentary Behavior Signs and Symptoms Weight Loss

Age range

45 year–75 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

About this study

Background and Aim: 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 supplemented with exercise, on weight loss and lipid profile, and to compare its efficiency with low-calorie diet with exercise among elderly adult men with abnormal weight gain.

Materials and Methods: Participants included sedentary men (age 45-75 years) with overweight or obesity (n=37). They were randomly divided into 2 groups including negative calorie diet with exercise, and low-calorie diet with exercise. Of all 37 participants, 30 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

NCDsport

Dietary Supplement

Negative Calorie Diet supplemented with exercise

Other names: group I

LCDsport

Dietary Supplement

Low-Calorie diet with exercise

Other names: group II

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Official study title

Investigating the Effects of Negative Calorie Diet Compared With Low-calorie Diet Under Exercise Condition on Weight Loss and Lipid Profile in Overweight/Obese Middle-aged and Older Men

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Mar 17, 2017
Registry last updated
Mar 21, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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