- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02399280
Effect of High Caloric Intake at Lunch Against Dinner on Weight Loss
April 3, 2017 updated by: Novindiet Clinic
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
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 .
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
70
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Tehran, Iran, Islamic Republic of, 1913635136
- NovinDiet Clinic
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 43 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Lunch
Lunch as main meal(LM)+ Diet
|
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.
|
Experimental: Dinner
Dinner as main meal(DM)+ Diet
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
weight loss
Time Frame: 12 weeks
|
12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
waist circumference
Time Frame: 12 weeks
|
12 weeks
|
Fasting plasma glucose level
Time Frame: 12 weeks
|
12 weeks
|
Lipid profiles
Time Frame: 12 weeks
|
12 weeks
|
Insulin resistance(HOMA)
Time Frame: 12 weeks
|
12 weeks
|
Body mass index
Time Frame: 12 weeks
|
12 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Hamid R Farshchi, MD, PhD, NovinDiet Clinic, School of Life Sciences, The University of Nottingham
- Principal Investigator: Ameneh Madjd, Dr., NovinDiet Clinic, School of Life Sciences, The University of Nottingham
- Principal Investigator: Ian A Macdonald, Prof., School of Life Sciences, The University of Nottingham
- Principal Investigator: Moira A Taylor, PhD, School of Life Sciences, The University of Nottingham
- Principal Investigator: Reza Malekzadeh, Prof., Digestive Disease Research Institute, Tehran University of Medical Sciences
- Principal Investigator: Alireza Delavari, MD, Digestive Disease Research Institute, Tehran University of Medical Sciences
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2015
Primary Completion (Actual)
June 1, 2015
Study Completion (Actual)
August 1, 2015
Study Registration Dates
First Submitted
March 22, 2015
First Submitted That Met QC Criteria
March 25, 2015
First Posted (Estimate)
March 26, 2015
Study Record Updates
Last Update Posted (Actual)
April 5, 2017
Last Update Submitted That Met QC Criteria
April 3, 2017
Last Verified
April 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ND-106
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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