NCT03066882

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.

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 obesity

Timeline
Completed

Started May 2012

Longer than P75 for not_applicable obesity

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

May 10, 2012

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 20, 2015

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2016

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

February 17, 2017

Completed
12 days until next milestone

First Posted

Study publicly available on registry

March 1, 2017

Completed
Last Updated

March 1, 2017

Status Verified

February 1, 2017

Enrollment Period

3.4 years

First QC Date

February 17, 2017

Last Update Submit

February 23, 2017

Conditions

ObesityOverweightLife Style

Keywords

Caloric RestrictionDietObesityOverweightSedentary LifestyleWeight lossWomen

Outcome Measures

Primary Outcomes (5)

  • Weight

    assessed in kg

    pre-study

  • Total cholesterol (Total-C)

    assessed in mg/dl

    pre-study

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

    assessed in mg/dl

    pre-study

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

    assessed in mg/dl

    pre-study

  • Triglycerides (TG)

    assessed in mg/dl

    pre-study

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 (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.

Dietary Supplement: NCD

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.

Dietary Supplement: LCD

Interventions

NCDDIETARY_SUPPLEMENT

negative calorie diet

Also known as: group I
Study group I
LCDDIETARY_SUPPLEMENT

low calorie diet

Also known as: group II
Study group II

Eligibility Criteria

Age45 Years - 75 Years
Sexfemale(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

ObesityOverweightSedentary BehaviorWeight Loss

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBehaviorBody Weight Changes

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

Study Record Dates

First Submitted

February 17, 2017

First Posted

March 1, 2017

Study Start

May 10, 2012

Primary Completion

September 20, 2015

Study Completion

October 30, 2016

Last Updated

March 1, 2017

Record last verified: 2017-02