Exploring the effect of high consumption of dairy products in a high-protein diet combined with aerobic exercise and calorie restriction on weight loss and central obesity reduction in overweight women
The study is a randomized clinical trial. The study aims to explore the effect of high consumption of dairy products in a high-protein diet combined with aerobic exercise and calorie restriction on weight loss and central obesity reduction in overweight women.
Design
A randomized intervention with 60 participants, with control group, parallel intervention groups with participants, blind evaluator
Settings and conduct
The study will be conducted at Imam Khomeini Hospital. The effect of a two-week diet with high protein and calcium restricted by 700 kcal per day combined with moderate intensity of aerobic exercise on weight loss and central obesity are measured and compared with a normal high-protein diet in similar conditions. The evaluator will be blind.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Individuals aged between 20 and 45 years, no history of disease
Exclusion criteria: Lactose intolerance and sensitivity to dairy protein, the presence of a metal device or heart pacemaker in the body, pregnancy, musculoskeletal problems and exercise-limiting neurological disorders that prevent the continuation of physical activity, weight-loss medications such as appetite suppressants, reluctance to cooperate
Intervention groups
Participants were randomly divided into the intervention group (the group on a high protein and dairy diet and a caloric intake restricted by 700 kcal, combined with moderate rate of aerobic exercise) and the control group (the group on a high protein and moderate dairy diet and a caloric intake restricted by 700 kcal daily, combined with moderate rate of aerobic exercise).
Main outcome variables
Waist circumference; abdominal and supra-iliac skin fold; body fat
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20201102049229N1
Registration date:2020-12-19, 1399/09/29
Registration timing:prospective
Last update:2020-12-19, 1399/09/29
Update count:0
Registration date
2020-12-19, 1399/09/29
Registrant information
Name
zahra bodaghabadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6119 2282
Email address
parnian.ziba10@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-04-04, 1400/01/15
Expected recruitment end date
2022-09-06, 1401/06/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Exploring the effect of high consumption of dairy products in a high-protein diet combined with aerobic exercise and calorie restriction on weight loss and central obesity reduction in overweight women
Public title
The effect of high consumption of dairy on women's weight loss
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Individuals with BMI between 25 and 29.9
Individuals aged between 20 and 45 years
No history of disease (uncontrolled diabetes, severe cardiovascular disease, musculoskeletal limitations and exercise-limiting neurological disorders, uncontrolled blood pressure, chronic obstructive pulmonary disease, migraine, kidney disease, taking any medication that affects a person's weight, appetite, heart rate or ability to do physical exercise
Exclusion criteria:
Lactose intolerance and sensitivity to dairy protein
The presence of a metal device or heart pacemaker in the body
Pregnancy
Musculoskeletal problems and exercise-limiting neurological disorders that prevent the continuation of physical activity
Weight-loss medications such as appetite suppressants
Reluctance to cooperate
Age
From 20 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization based on a single sequence of random allocations is called simple randomization. In this study, simple randomization is used. Individuals are randomly assigned to one of the two study groups using the table of random numbers and receive the intervention of the same group. Accidental concealment will be conducted by a second person who does not participate in other stages of the intervention.
Blinding (investigator's opinion)
Single blinded
Blinding description
The evaluator of the results will be blind. The measurement and analysis, which are carried out two weeks after the diet, will be conducted by this person.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tehran University of Medical Sciences
Street address
Central Building of Tehran University of Medical Sciences, Ghods St., Keshavarz Blvd.
City
Tehran
Province
Tehran
Postal code
1417653761
Approval date
2020-10-20, 1399/07/29
Ethics committee reference number
IR.TUMS.IKHC.REC.1399.276
Health conditions studied
1
Description of health condition studied
Overweight
ICD-10 code
E66
ICD-10 code description
Overweight and obesity
Primary outcomes
1
Description
Weight loss
Timepoint
At the beginning of the study and two weeks later
Method of measurement
Weight measurement by compartment body composition analyzer
2
Description
Central obesity reduction
Timepoint
At the beginning of the study and two weeks later
Method of measurement
Measuring waist circumference, skin folds, and supra-iliac
Secondary outcomes
1
Description
Body composition
Timepoint
At the beginning of the study and two weeks after that
Method of measurement
Compartment body composition analyzer AVIS334
Intervention groups
1
Description
Intervention group: the group on a high-protein and high level of dairy diet and daily calorie restriction of 700 Kcal combined with medium intensity of aerobic exercise. For this group, a diet of high protein and calcium (1.5 grams of protein per kilogram of body weight) with dairy sources (milk-casein) and 700 kcal restriction per day is prescribed as needed. Moreover, aerobic exercise with medium intensity is prescribed (including jogging or running on treadmill 3 to 5 days a week for 2 weeks). Patients are given a logbook to record exercise, and a weekly food reminder is requested from the patient. After 2 weeks, the analysis is undertaken again.
Category
Prevention
2
Description
Control group: the group on a high-protein but moderate level of dairy diet and daily calorie restriction of 700 Kcal combined with medium intensity of aerobic exercise. Aerobic exercise with medium intensity is aslo prescribed for this group (including jogging or running on treadmill 3 to 5 days a week for 2 weeks). Patients are given a logbook to record exercise, and a weekly food reminder is requested from the patient. After 2 weeks, the analysis is undertaken again.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini Hospital
Full name of responsible person
Zahra Alizadeh
Street address
Imam Khomeini Hospital, Keshavarz Blvd.
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6119 2282
Email
z_alizadeh@tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Hajar Moamai
Street address
4th floor, Central Building of Tehran University of Medical Sciences, Qods St., Keshavarz Blvd.
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 8163 3612
Email
z_alizadeh@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Zahra Alizadeh
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Sport Medicine
Street address
No. 7, Sports Medicine Research Center, Opposite of Shariati Hospital, Jalal Al-Ahmad Highway
City
Tehran
Province
Tehran
Postal code
57814395
Phone
+98 21 6119 2282
Fax
+98 21 8800 3539
Email
z_alizadeh@tums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Zahra Alizadeh
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Sport Medicine
Street address
No. 7, Sports Medicine Research Center, the opposite of Shariati Hospital, Jalal Al-Ahmad Highway
City
Tehran
Province
Tehran
Postal code
57814395
Phone
+98 21 6119 2282
Fax
+98 21 8800 3539
Email
z_alizadeh@tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Zahra Alizadeh
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Sport Medicine
Street address
No. 7, Sports Medicine Research Center, the opposite of Shariati Hospital, Jalal Al-Ahmad Highway
City
Tehran
Province
Tehran
Postal code
57814395
Phone
+98 21 6119 2282
Fax
+98 21 8800 3539
Email
z_alizadeh@tums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is no further information.
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
Initial results and other items at the request of researchers
When the data will become available and for how long
The period of access starts 6 months after the publication of results.
To whom data/document is available
Please contact this email: z_alizadeh@tums.ac.ir
Under which criteria data/document could be used
Please contact this email: z_alizadeh@tums.ac.ir
From where data/document is obtainable
Please contact this email: z_alizadeh@tums.ac.ir
What processes are involved for a request to access data/document