- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03129841
Effects of Late Dinner Against Early Dinner on Weight Loss Healthy Obese Women
October 24, 2019 updated by: Novindiet Clinic
Effects of Late Dinner Against Early Dinner on Weight Loss Healthy Obese Women in a Weight-loss Program: a Randomized Clinical Trial
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.
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
- 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
18 years to 45 years (Adult)
Accepts Healthy Volunteers
Yes
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: early dinner+Diet
|
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.
Other Names:
|
|
Experimental: late dinner+Diet
|
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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
weight loss
Time Frame: 12 Weeks
|
kg
|
12 Weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
waist circumference
Time Frame: 12 Weeks
|
cm
|
12 Weeks
|
|
fasting plasma glucose
Time Frame: 12 Weeks
|
mmol/L
|
12 Weeks
|
|
insulin level
Time Frame: 12 Weeks
|
mU/l
|
12 Weeks
|
|
insulin resistance (HOMA-IR)
Time Frame: 12 Weeks
|
Score
|
12 Weeks
|
|
glycosylated hemoglobin (HbA1c)
Time Frame: 12 Weeks
|
percentage (%)
|
12 Weeks
|
|
lipid profiles
Time Frame: 12 Weeks
|
mmol/l
|
12 Weeks
|
|
Liver Enzyme (SGOT, SGPT)
Time Frame: 12 Weeks
|
U/l
|
12 Weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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 (Actual)
June 1, 2017
Primary Completion (Actual)
October 5, 2017
Study Completion (Actual)
November 18, 2017
Study Registration Dates
First Submitted
April 15, 2017
First Submitted That Met QC Criteria
April 22, 2017
First Posted (Actual)
April 26, 2017
Study Record Updates
Last Update Posted (Actual)
October 28, 2019
Last Update Submitted That Met QC Criteria
October 24, 2019
Last Verified
October 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ND-202
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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