NCT02399280

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 .

Trial Health

87
On Track

Trial Health Score

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

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable obesity

Timeline
Completed

Started Feb 2015

Shorter than P25 for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2015

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 22, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 26, 2015

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
Last Updated

April 5, 2017

Status Verified

April 1, 2017

Enrollment Period

4 months

First QC Date

March 22, 2015

Last Update Submit

April 3, 2017

Conditions

ObesityOverweight

Keywords

Meal patternweight losshigh caloric intakeDinnerLunch

Outcome Measures

Primary Outcomes (1)

  • weight loss

    12 weeks

Secondary Outcomes (5)

  • waist circumference

    12 weeks

  • Fasting plasma glucose level

    12 weeks

  • Lipid profiles

    12 weeks

  • Insulin resistance(HOMA)

    12 weeks

  • Body mass index

    12 weeks

Study Arms (2)

Lunch

EXPERIMENTAL

Lunch as main meal(LM)+ Diet

Behavioral: Lunch as main meal(LM)+ Diet

Dinner

EXPERIMENTAL

Dinner as main meal(DM)+ Diet

Behavioral: Dinner as main meal(DM)+ Diet

Interventions

Lunch as main meal(LM)+ DietBEHAVIORAL

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.

Lunch
Dinner as main meal(DM)+ DietBEHAVIORAL

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.

Dinner

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

NovinDiet Clinic

Tehran, Tehran Province, 1913635136, Iran

Location

Related Publications (1)

  • 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.

    PMID: 27581472DERIVED

MeSH Terms

Conditions

ObesityOverweightWeight Loss

Interventions

LunchMeals

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

FoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Hamid R Farshchi, MD, PhD

    NovinDiet Clinic, School of Life Sciences, The University of Nottingham

    STUDY CHAIR

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 22, 2015

First Posted

March 26, 2015

Study Start

February 1, 2015

Primary Completion

June 1, 2015

Study Completion

August 1, 2015

Last Updated

April 5, 2017

Record last verified: 2017-04

Locations

IR(1)