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Effect of High Caloric Intake at Lunch Against Dinner on Weight Loss

Primary Purpose

Obesity, Overweight

Status

Completed

Phase

Not Applicable

Locations

Iran, Islamic Republic of

Study Type

Interventional

Intervention

Lunch as main meal(LM)+ Diet

Dinner as main meal(DM)+ Diet

About this trial

This is an interventional treatment trial for Obesity focused on measuring Meal pattern, weight loss, high caloric intake, Dinner, Lunch

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

Must have Body mass index (BMI) between 27-35 kg/ m².
Must be able to have moderate exercise.
Must be interested to have weight loss.

Exclusion Criteria:

Participating in a research project involving weight loss or physical activity in the previous six months.
Pregnancy or lactation during the previous 6 months, or planned pregnancy in the next six months.
Taking medication that could affect metabolism or change body weight.
Report heart problems, chest pain, and cancer within the last five years.
Smoking
Menopause
Diagnosis of any chronic disease such as fatty liver, cancer, chemo/radio therapy, heart disease, immune compromised conditions, abnormal thyroid hormone level.

Sites / Locations

NovinDiet Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Lunch

Dinner

Arm Description

Lunch as main meal(LM)+ Diet

Dinner as main meal(DM)+ Diet

Outcomes

Primary Outcome Measures

weight loss

Secondary Outcome Measures

waist circumference

Fasting plasma glucose level

Lipid profiles

Insulin resistance(HOMA)

Body mass index

Full Information

NCT ID

NCT02399280

First Posted

March 22, 2015

Last Updated

April 3, 2017

Sponsor

Novindiet Clinic

Collaborators

University of Nottingham, Tehran University of Medical Sciences

1. Study Identification

Unique Protocol Identification Number

NCT02399280

Brief Title

Effect of High Caloric Intake at Lunch Against Dinner on Weight Loss

Official Title

Effect of High Caloric Intake at Lunch Against Dinner on Weight Loss of Overweight and Obese Women Attending a Weight Loss Program, a Randomized Clinical Trial

Study Type

Interventional

2. Study Status

Record Verification Date

April 2017

Overall Recruitment Status

Completed

Study Start Date

February 2015 (undefined)

Primary Completion Date

June 2015 (Actual)

Study Completion Date

August 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Novindiet Clinic

Collaborators

University of Nottingham, Tehran University of Medical Sciences

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The purpose of the present study is to evaluate the effect of consuming higher caloric intake at lunch in contrast to dinner on weight loss of obese and overweight female adults when they are in a multidisciplinary weight loss plan .

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Obesity, Overweight

Keywords

Meal pattern, weight loss, high caloric intake, Dinner, Lunch

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

70 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Lunch

Arm Type

Experimental

Arm Description

Lunch as main meal(LM)+ Diet

Arm Title

Dinner

Arm Type

Experimental

Arm Description

Dinner as main meal(DM)+ Diet

Intervention Type

Behavioral

Intervention Name(s)

Lunch as main meal(LM)+ Diet

Intervention Description

Subjects are asked to have high caloric intake at lunch and low caloric intake at dinner, while they are on a multidisciplinary weight loss plan for 12 weeks.

Intervention Type

Behavioral

Intervention Name(s)

Dinner as main meal(DM)+ Diet

Intervention Description

Subjects are asked to have high caloric intake at dinner and low caloric intake at lunch, while they are on a multidisciplinary weight loss plan for 12 weeks.

Primary Outcome Measure Information:

Title

weight loss

Time Frame

12 weeks

Secondary Outcome Measure Information:

Title

waist circumference

Time Frame

12 weeks

Title

Fasting plasma glucose level

Time Frame

12 weeks

Title

Lipid profiles

Time Frame

12 weeks

Title

Insulin resistance(HOMA)

Time Frame

12 weeks

Title

Body mass index

Time Frame

12 weeks

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Must have Body mass index (BMI) between 27-35 kg/ m². Must be able to have moderate exercise. Must be interested to have weight loss. Exclusion Criteria: Participating in a research project involving weight loss or physical activity in the previous six months. Pregnancy or lactation during the previous 6 months, or planned pregnancy in the next six months. Taking medication that could affect metabolism or change body weight. Report heart problems, chest pain, and cancer within the last five years. Smoking Menopause Diagnosis of any chronic disease such as fatty liver, cancer, chemo/radio therapy, heart disease, immune compromised conditions, abnormal thyroid hormone level.

Overall Study Officials: