Effects of Late Dinner Against Early Dinner on Weight Loss Healthy Obese Women
Primary Purpose
Obesity, Overweight
Status
Completed
Phase
Not Applicable
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Early dinner+Diet
Late dinner+Diet
Sponsored by
About this trial
This is an interventional treatment trial for Obesity focused on measuring weight loss, dietary pattern, late dinner, early dinner
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.
Sites / Locations
- NovinDiet Clinic
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
early dinner+Diet
late dinner+Diet
Arm Description
Outcomes
Primary Outcome Measures
weight loss
kg
Secondary Outcome Measures
waist circumference
cm
fasting plasma glucose
mmol/L
insulin level
mU/l
insulin resistance (HOMA-IR)
Score
glycosylated hemoglobin (HbA1c)
percentage (%)
lipid profiles
mmol/l
Liver Enzyme (SGOT, SGPT)
U/l
Full Information
NCT ID
NCT03129841
First Posted
April 15, 2017
Last Updated
October 24, 2019
Sponsor
Novindiet Clinic
Collaborators
University of Nottingham, Tehran University of Medical Sciences
1. Study Identification
Unique Protocol Identification Number
NCT03129841
Brief Title
Effects of Late Dinner Against Early Dinner on Weight Loss Healthy Obese Women
Official Title
Effects of Late Dinner Against Early Dinner on Weight Loss Healthy Obese Women in a Weight-loss Program: a Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
June 1, 2017 (Actual)
Primary Completion Date
October 5, 2017 (Actual)
Study Completion Date
November 18, 2017 (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
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The aim of the present study is to test whether late eating dinner could affect the amount of weight loss in healthy obese women in a weight-loss program.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Overweight
Keywords
weight loss, dietary pattern, late dinner, early dinner
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
early dinner+Diet
Arm Type
Experimental
Arm Title
late dinner+Diet
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Early dinner+Diet
Other Intervention Name(s)
ED
Intervention Description
Subjects are asked to eat dinner meals between 7:00- 7:30 PM in the ED group, while they are on a multidisciplinary weight loss plan for 12 weeks.
Intervention Type
Behavioral
Intervention Name(s)
Late dinner+Diet
Other Intervention Name(s)
LD
Intervention Description
Subjects are asked to eat their dinner meal between 10:30-11:00PM, while they are on a multidisciplinary weight loss plan for 12 weeks.
Primary Outcome Measure Information:
Title
weight loss
Description
kg
Time Frame
12 Weeks
Secondary Outcome Measure Information:
Title
waist circumference
Description
cm
Time Frame
12 Weeks
Title
fasting plasma glucose
Description
mmol/L
Time Frame
12 Weeks
Title
insulin level
Description
mU/l
Time Frame
12 Weeks
Title
insulin resistance (HOMA-IR)
Description
Score
Time Frame
12 Weeks
Title
glycosylated hemoglobin (HbA1c)
Description
percentage (%)
Time Frame
12 Weeks
Title
lipid profiles
Description
mmol/l
Time Frame
12 Weeks
Title
Liver Enzyme (SGOT, SGPT)
Description
U/l
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
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.
Facility Information:
Facility Name
NovinDiet Clinic
City
Tehran
Country
Iran, Islamic Republic of
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Effects of Late Dinner Against Early Dinner on Weight Loss Healthy Obese Women
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