NCT03082807

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 men with abnormal weight gain.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
37

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2011

Typical duration for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 25, 2011

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 20, 2012

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2012

Completed
4.2 years until next milestone

First Submitted

Initial submission to the registry

March 7, 2017

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 17, 2017

Completed
Last Updated

March 21, 2017

Status Verified

March 1, 2017

Enrollment Period

1.6 years

First QC Date

March 7, 2017

Last Update Submit

March 17, 2017

Conditions

MenDiet ModificationObesityOverweightLife StyleWeight Loss

Keywords

Caloric RestrictionDietExerciseObesityOverweightSedentary lifestyleweight lossMen

Outcome Measures

Primary Outcomes (5)

  • Weight

    assessed in kg

    Baseline

  • Total cholesterol (Total-C)

    assessed in mg/dl

    Baseline

  • High-density lipoprotein -cholesterol (HDL-C)

    assessed in mg/dl

    Baseline

  • Low-density lipoprotein -cholesterol (LDL-C)

    assessed in mg/dl

    Baseline

  • Triglycerides (TG)

    assessed in mg/dl

    Baseline

Secondary Outcomes (4)

  • Weight

    3-month

  • Total cholesterol (Total-C)

    3-month

  • High-density lipoprotein -cholesterol (HDL-C)

    3-month

  • Low-density lipoprotein -cholesterol (LDL-C)

    3-month

Study Arms (2)

Study group I

EXPERIMENTAL

Study group I (18 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

Study group II

EXPERIMENTAL

Study group II (19 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

Interventions

NCDsportDIETARY_SUPPLEMENT

Negative Calorie Diet supplemented with exercise

Also known as: group I
Study group I
LCDsportDIETARY_SUPPLEMENT

Low-Calorie diet with exercise

Also known as: group II
Study group II

Eligibility Criteria

Age45 Years - 75 Years
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsParticipants 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.
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Multiple Endocrine Neoplasia Type 1ObesityOverweightWeight LossMotor ActivitySedentary Behavior

Condition Hierarchy (Ancestors)

Multiple Endocrine NeoplasiaEndocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsNeoplasms, Multiple PrimaryNeoplastic Syndromes, HereditaryGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesEndocrine System DiseasesOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBody Weight ChangesBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Asst. Prof. of sports medicine (sports injury and corrective movement)

Study Record Dates

First Submitted

March 7, 2017

First Posted

March 17, 2017

Study Start

February 25, 2011

Primary Completion

September 20, 2012

Study Completion

December 15, 2012

Last Updated

March 21, 2017

Record last verified: 2017-03