Clinical trial NCT02399280: 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
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Overweight
Keywords: Meal pattern
weight loss
high caloric intake
Dinner
Lunch
Lead sponsor: Novindiet Clinic
Sponsor class: OTHER
Collaborators: name: University of Nottingham
name: Tehran University of Medical Sciences
First posted: 2015-03-26
Enrollment: 70
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 .


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.

Primary outcomes:
measure: weight loss
timeFrame: 12 weeks
Secondary outcomes:
measure: waist circumference
timeFrame: 12 weeks
measure: Fasting plasma glucose level
timeFrame: 12 weeks
measure: Lipid profiles
timeFrame: 12 weeks
measure: Insulin resistance(HOMA)
timeFrame: 12 weeks
measure: Body mass index
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: NovinDiet Clinic
Study officials:
affiliation: NovinDiet Clinic, School of Life Sciences, The University of Nottingham
name: Hamid R Farshchi, MD, PhD
role: STUDY_CHAIR
affiliation: NovinDiet Clinic, School of Life Sciences, The University of Nottingham
name: Ameneh Madjd, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: School of Life Sciences, The University of Nottingham
name: Ian A Macdonald, Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: School of Life Sciences, The University of Nottingham
name: Moira A Taylor, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Digestive Disease Research Institute, Tehran University of Medical Sciences
name: Reza Malekzadeh, Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: Digestive Disease Research Institute, Tehran University of Medical Sciences
name: Alireza Delavari, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Madjd A, Taylor MA, Delavari A, Malekzadeh R, Macdonald IA, Farshchi HR. Beneficial effect of high energy intake at lunch rather than dinner on weight loss in healthy obese women in a weight-loss program: a randomized clinical trial. Am J Clin Nutr. 2016 Oct;104(4):982-989. doi: 10.3945/ajcn.116.134163. Epub 2016 Aug 31.