Overweight and ObesityNCT05581862
Effect Of Meal Frequency On Weight Loss And Body Composition Of Obese And Overweight Women
A study testing 3 meals+3 snacks and 3 meals in people with Overweight and Obesity, run by Eastern Mediterranean University at 1 site in Cyprus.
Trial summary
Studies showing the relationship between meal frequency, weight loss and anthropometric measurements are contradictory. This study is planned and conducted to observe the effects of meal frequency (3 meals+3 snacks vs 3 meals) on weight loss, anthropometric measurements and body composition with 3-month energy… Read more about this study
- Who is it for?
- Ages 19 to 64 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Overweight and Obesity
- What is being tested?
- 3 meals+3 snacks and 3 meals
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteCyprus
- Study dates
- May 2015to Oct 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 64 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 19-64 years old Women,
- Healthy subjects with no chronic diseases,
- Subjects who were not taking any drug or dietary supplements,
- Subjects who have not made any changes in their physical activity or eating habits for weight loss in the last 6 months,
- Subjects with a BMI ≥ 27 kg/m2
Who cannot join
- Failure to meet the criteria for inclusion
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect Of Meal Frequency On Weight Loss And Body Composition Of Obese And Overweight Women Having Medical Nutrition Therapy
Studies showing the relationship between meal frequency, weight loss and anthropometric measurements are contradictory. This study is planned and conducted to observe the effects of meal frequency (3 meals+3 snacks vs 3 meals) on weight loss, anthropometric measurements and body composition with 3-month energy restricted Medical Nutrition Therapy program in 19-64 years old women with a BMI ≥ 27 kg/m2.
Read the detailed description
The study was conducted with 40 female volunteers between the ages of 19-64 years, with a Body Mass Index (BMI) ≥27. Energy restricted individualized weight loss programs were applied with different meal frequencies (3 meals+3 snacks/day vs 3 meals/day) in a 3 month follow up period. 20 participants were randomized in 3 meals+3 snacks and 20 participants were randomized in 3 meals group. Food consumption was questioned, and anthropometric measurements and body composition were measured before the study and repeated each week till the end of the study. Three day food records (2 week days and 1 weekend day) taken before the intervention were evaluated and five hundred calorie was subtracted from the average energy calculated form the food records to determine the energy of the weight loss plans . Breakfast, lunch and dinner are planned as main meals and the beverages and/or food eaten between main meals were planned as snacks (50-200 kcal). For both of the groups dietary weight loss program was planned by the same dietitian. Macronutrient composition of the weight loss plan was designed according to the recommendations of the Turkish Dietary Guidelines as 45-60 % carbohydrate, 10-20 % protein and 20-35 % fat for both of the groups.
- Conditions
- Overweight and Obesity
- Being tested
- 3 meals+3 snacks, 3 meals
- Keywords
- Meal Frequency, body composition, BMI, waist circumference
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3 meals+3 snacksBehavioural
All of the 20 subjects consumed an energy restricted weight loos plan with 3 main meals and 3 snacks for 3 months
3 mealsBehavioural
All of the 20 subjects consumed an energy restricted weight loos plan with 3 main meals for 3 months
| Study group | Role | What they receive |
|---|---|---|
| 3 Meals+3 Snacks | Experimental | This group was followed up for 3 months with an energy restricted weight loss plan composed of 3 main meals and 3 snacks Receives: Behavioral: 3 meals+3 snacks |
| 3 Meals | Experimental | This group was followed up for 3 months with an energy restricted weight loss plan composed of 3 main meals Receives: Behavioral: 3 meals |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in BMI (kg/m2)
Both of the groups had a significant change in BMI, but there was no difference among the groups
Measured: 3 months
Change in Waist circumference (cm)
Both of the groups had a significant change in waist circumference, but there was no difference among the groups
Measured: 3 months
Change in total body fat (kg)
Both of the groups had a significant change in total body fat however the rate of change in total body fat was significantly higher in 3 meals+3snacks group
Measured: 3 months
Change in body fat percentage (%)
Both of the groups had a significant change in body fat percentage however the rate of change in body fat percentage was significantly higher in 3 meals+3snacks group
Measured: 3 months
Change in fat free mass percentage (%)
Both of the groups had a significant change in fat free mass percentage, however the rate of change was significantly higher in 3 meals+3 snacks group
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2022
- Study startMay 2015
- Primary completionOct 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Overweight and ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eastern Mediterranean University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Müjgan Öztürk, PhD, Study director, Eastern Mediterranean University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05581862
- Sponsor's protocol ID
- 2016/21-03
- Status last verified
- Oct 2022
- First submitted
- 5 Oct 2022
- Last updated
- 17 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Otuken Koroglu Y, Ozturk M. Meal Frequency Does Not Affect Weight Loss in Overweight/Obese Women but Affects the Body Composition: A Randomized Controlled Trial. J Am Nutr Assoc. 2024 Aug;43(6):489-497. doi: 10.1080/27697061.2024.2316636. Epub 2024 Feb 13.
PubMed 38349951
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect Of Meal Frequency On Weight Loss And Body Composition Of Obese And Overweight Women Having Medical Nutrition Therapy
- ClinicalTrials.gov ID
- NCT05581862
- Acronym / sponsor ID
- 2016/21-03
- Conditions
- Overweight and Obesity
- Keywords
- Meal Frequency, body composition, BMI, waist circumference
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Eastern Mediterranean UniversityUniversity, hospital or other
- Study start
- May 2015 (actual)
- Primary completion
- Oct 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 17 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Studies showing the relationship between meal frequency, weight loss and anthropometric measurements are contradictory. This study is planned and conducted to observe the effects of meal frequency (3 meals+3 snacks vs 3 meals) on weight loss, anthropometric measurements and body composition with 3-month energy restricted Medical Nutrition Therapy program in 19-64 years old women with a BMI ≥ 27 kg/m2.
Detailed description
The study was conducted with 40 female volunteers between the ages of 19-64 years, with a Body Mass Index (BMI) ≥27. Energy restricted individualized weight loss programs were applied with different meal frequencies (3 meals+3 snacks/day vs 3 meals/day) in a 3 month follow up period. 20 participants were randomized in 3 meals+3 snacks and 20 participants were randomized in 3 meals group. Food consumption was questioned, and anthropometric measurements and body composition were measured before the study and repeated each week till the end of the study. Three day food records (2 week days and 1 weekend day) taken before the intervention were evaluated and five hundred calorie was subtracted from the average energy calculated form the food records to determine the energy of the weight loss plans . Breakfast, lunch and dinner are planned as main meals and the beverages and/or food eaten between main meals were planned as snacks (50-200 kcal). For both of the groups dietary weight loss program was planned by the same dietitian. Macronutrient composition of the weight loss plan was designed according to the recommendations of the Turkish Dietary Guidelines as 45-60 % carbohydrate, 10-20 % protein and 20-35 % fat for both of the groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 3 Meals+3 Snacks | Experimental | Behavioral: 3 meals+3 snacksThis group was followed up for 3 months with an energy restricted weight loss plan composed of 3 main meals and 3 snacks |
| 3 Meals | Experimental | Behavioral: 3 mealsThis group was followed up for 3 months with an energy restricted weight loss plan composed of 3 main meals |
Who may qualify
- Ages
- 19 to 64 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 19-64 years old Women,
- Healthy subjects with no chronic diseases,
- Subjects who were not taking any drug or dietary supplements,
- Subjects who have not made any changes in their physical activity or eating habits for weight loss in the last 6 months,
- Subjects with a BMI ≥ 27 kg/m2
Key exclusion criteria (1 listed)
- Failure to meet the criteria for inclusion
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 3 meals+3 snacksAll of the 20 subjects consumed an energy restricted weight loos plan with 3 main meals and 3 snacks for 3 months | Behavioural | 3 Meals+3 Snacks |
| 3 mealsAll of the 20 subjects consumed an energy restricted weight loos plan with 3 main meals for 3 months | Behavioural | 3 Meals |
Primary outcome
Change in BMI (kg/m2)
Time frame: 3 months
Both of the groups had a significant change in BMI, but there was no difference among the groups
Change in Waist circumference (cm)
Time frame: 3 months
Both of the groups had a significant change in waist circumference, but there was no difference among the groups
Change in total body fat (kg)
Time frame: 3 months
Both of the groups had a significant change in total body fat however the rate of change in total body fat was significantly higher in 3 meals+3snacks group
Change in body fat percentage (%)
Time frame: 3 months
Both of the groups had a significant change in body fat percentage however the rate of change in body fat percentage was significantly higher in 3 meals+3snacks group
Change in fat free mass percentage (%)
Time frame: 3 months
Both of the groups had a significant change in fat free mass percentage, however the rate of change was significantly higher in 3 meals+3 snacks group
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2022.
- Derived from this study: PubMed 38349951Otuken Koroglu Y, Ozturk M. Meal Frequency Does Not Affect Weight Loss in Overweight/Obese Women but Affects the Body Composition: A Randomized Controlled Trial. J Am Nutr Assoc. 2024 Aug;43(6):489-497. doi: 10.1080/27697061.2024.2316636. Epub 2024 Feb 13.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Müjgan Öztürk, PhD study director
Eastern Mediterranean University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 3 meals+3 snacks and 3 meals in people with Overweight and Obesity, run by Eastern Mediterranean University at 1 site in Cyprus.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Cyprus. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in BMI (kg/m2) (time frame: 3 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05581862, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Oct 2022.