ObesityNCT06476444
Association of Sedentary Behaviour and Habitual Diet With Resting Fat Oxidation in Women With Overweight and Obesity
An observational study of Obesity and Healthy, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to investigate the relationship between physical activity levels, dietary patterns with fat oxidation at rest in normal lean individuals and those with overweight and obese. Read more about this study
- Who is it for?
- Ages 25 to 50 years, women onlyHealthy volunteers can take part
- How many people
- 120 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2023to 10 Jun 2024
- Phase
- Observational
- 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 25 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Sedentary women aged 25 to 50 with a body mass index range of 18.5-24.9 kg/m2 (normal weight; control group) and 25-34.9 kg/m2 (overweight and obese; research group) will be included in the study.
Who may be able to join
- Sedentary women aged 25-50 years with a body mass index range of 18.5-24.9 kg/m2 (normal weight) and 25-34.9 kg/m2 (overweight and obese) will be included in the study.
Who cannot join
- Smokers,
- Taking any medication or supplements that may affect metabolism,
- Dieting for more than 6 months,
- Pregnant or breastfeeding,
- Amenorrhoea,
- Individuals who meet the physical activity recommendations of the World Health Organisation (at least 150 min of moderate-to-vigorous exercise or at least 75 min of high-intensity exercise per week),
- Individuals with any chronic disease other than obesity will be excluded from the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Association of Physical Activity, Sedentary Behaviour and Habitual Diet With Resting Fat Oxidation in Women With Overweight and Obesity
The aim of this study is to investigate the relationship between physical activity levels, dietary patterns with fat oxidation at rest in normal lean individuals and those with overweight and obese.
Read the detailed description
Obesity is associated with a changing food environment where low-cost, high-energy-dense fast foods are readily available, and physical activity levels are decreasing. Additionally, metabolic flexibility, defined as the organisms ability to switch between metabolic fuels, is impaired in obesity and is known to play a significant role in the development of chronic diseases. In these disease states, a metabolically inflexible condition is typically characterized by a reduced ability to regulate fat oxidation during fasting and carbohydrate oxidation during satiety. Therefore, considering the rising trend in obesity, understanding the factors related to metabolic flexibility becomes critical. It is known that numerous factors such as diet composition, eating habits, physical activity level, and sedentary behavior affect metabolic flexibility. However, unlike dietary and exercise interventions, the number of studies examining the impact of individuals eating habits and physical activity levels on resting fat oxidation is limited, and this topic has not yet been researched in obese individuals.
Moreover, another important concept known to have adverse effects on metabolic health independently of physical inactivity is sedentary behavior. Sedentary behavior is defined as "activities that require low energy expenditure while sitting, reclining, or lying down." However, the extent to which daily sedentary time and interruptions of this time with physical activities affect resting fat oxidation, an important variable of metabolic health, is not known.
In this context, the aim of this study is to comparatively determine the relationship between physical activity levels, sedentary behaviors, habitual diet, and resting fat oxidation in normal-weight and overweight/obese women. A total of 118 healthy women aged 25-50 years (normal weight, n=60; body mass index (BMI) = 18.5 - 24.9 kg/m²) and overweight/obese (n=60; BMI = 25.0 - 34.9 kg/m²) will participate in this study. All participants' body composition and resting metabolic rate measurements will be conducted, and fat and carbohydrate oxidation will be determined. The dietary habits, 4-day physical activity levels, and sedentary behaviors of all participants will be assessed using appropriate measurement methods.
The findings of this project are expected to reveal the extent to which dietary habits, physical activity, and sedentary behavior throughout the day affect resting fat oxidation in overweight/obese and normal-weight individuals. These findings will provide important evidence on how dietary habits and sedentary behaviors can improve resting fat oxidation, an important indicator of metabolic flexibility, without the need for dietary and exercise interventions
- Keywords
- Metabolism, Health, Obesity, Diet, Physical Activity
- Medical subject headings
- Obesity, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1. Women with Overweight and Obesity (25.0-34.9 BMI) | Healthy women with overweight and women without any chronic conditions other than obesity In this cross-sectional study, indirect calorimetry will be used to determine resting fat oxidation in these participants. Subsequently, the relationship between the resting fat oxidation data obtained with the habitual diet and physical activity status of these participants will be evaluated. Dietary patterns and physical activity will be assessed with 4 consecutive daily food consumption records and Actigraph GT3X+ devices, respectively. | |
| 2. Women with normal weight (18.5-24.9 BMI) | Healthy women with normal weight. In this cross-sectional study, indirect calorimetry will be used to determine resting fat oxidation in these participants. Thus, resting fat oxidation data of healthy women with normal weight and women with obesity/overweight will be compared. Subsequently, the relationship between the resting fat oxidation data obtained with the habitual diet and physical activity status of these participants will be evaluated. Dietary patterns and physical activity will be assessed with 4 consecutive daily food consumption records and Actigraph GT3X+ devices, respectively. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Resting fat oxidation
In order to determine the relationship of dietary habits and habitual physical activity levels with resting fat oxidation in healthy overweight, obese and normal weight individuals, resting fat oxidation measurements will be performed with a indirect calorimetry (Cardio Pulmonary Exercise Testing, Quark CPET, Italy).All resting fat oxidation tests will be conducted in the same quiet room under a controlled ambient temperature (22-24 °C) and humidity (35-45%). Subjects will be instructed to arrive at the laboratory at 8 a.m. by car or by bus (avoiding any physical activity after waking up) and having fasted for at least 10-12 hours. In addition to this, they will be advised to avoid any moderate physical activity for the 24 h before the test day or any vigorous intensity exercise in the prior 48 h.
Measured: From July 2024 to October 2024
The relationship between habitual physical activity level and sedentary behaviour with resting fat oxidation
Participants' habitual physical activity and sedentary behaviour will be measured with an accelerometer (Actigraph, USA) for 4 consecutive days to determine the relationship with resting fat oxidation.
Measured: July 2024- October 2024
Dietary pattern and fat oxidation
In order to determine the relationship of macronutrient intake and food group consumption with resting fat oxidation, 4-day food consumption records will be obtained from the participants.
Measured: July 2024- October 2024
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2024
- Study start1 Sep 2023
- Primary completion15 May 2024
- Study completion10 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Hacettepe UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zeynep Ergun, Hacettepe University
- Investigators
- Necip Demirci, MSc., Study chair, Hacettepe UniversityMuhammed Atakan, Ph.D, Principal investigator, Hacettepe UniversityZeynep Ergun, BSc, Study chair, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06476444
- Sponsor's protocol ID
- HU-SB-ZE-01
- Status last verified
- Jun 2024
- First submitted
- 21 Jun 2024
- Last updated
- 1 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: I can share my data when requested after the study is published.
Publications
Fletcher G, Eves FF, Glover EI, Robinson SL, Vernooij CA, Thompson JL, Wallis GA. Dietary intake is independently associated with the maximal capacity for fat oxidation during exercise. Am J Clin Nutr. 2017 Apr;105(4):864-872. doi: 10.3945/ajcn.116.133520. Epub 2017 Mar 1.
PubMed 28251936Jurado-Fasoli L, Amaro-Gahete FJ, Merchan-Ramirez E, Labayen I, Ruiz JR. Relationships between diet and basal fat oxidation and maximal fat oxidation during exercise in sedentary adults. Nutr Metab Cardiovasc Dis. 2021 Apr 9;31(4):1087-1101. doi: 10.1016/j.numecd.2020.11.021. Epub 2020 Dec 1.
PubMed 33549436
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association of Physical Activity, Sedentary Behaviour and Habitual Diet With Resting Fat Oxidation in Women With Overweight and Obesity
- ClinicalTrials.gov ID
- NCT06476444
- Acronym / sponsor ID
- HU-SB-ZE-01
- Keywords
- Metabolism, Health, Obesity, Diet, Physical Activity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 15 May 2024 (actual)
- Study completion
- 10 Jun 2024 (actual)
- First posted
- 26 Jun 2024 (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.
The aim of this study is to investigate the relationship between physical activity levels, dietary patterns with fat oxidation at rest in normal lean individuals and those with overweight and obese.
Detailed description
Obesity is associated with a changing food environment where low-cost, high-energy-dense fast foods are readily available, and physical activity levels are decreasing. Additionally, metabolic flexibility, defined as the organisms ability to switch between metabolic fuels, is impaired in obesity and is known to play a significant role in the development of chronic diseases. In these disease states, a metabolically inflexible condition is typically characterized by a reduced ability to regulate fat oxidation during fasting and carbohydrate oxidation during satiety. Therefore, considering the rising trend in obesity, understanding the factors related to metabolic flexibility becomes critical. It is known that numerous factors such as diet composition, eating habits, physical activity level, and sedentary behavior affect metabolic flexibility. However, unlike dietary and exercise interventions, the number of studies examining the impact of individuals eating habits and physical activity levels on resting fat oxidation is limited, and this topic has not yet been researched in obese individuals.
Moreover, another important concept known to have adverse effects on metabolic health independently of physical inactivity is sedentary behavior. Sedentary behavior is defined as "activities that require low energy expenditure while sitting, reclining, or lying down." However, the extent to which daily sedentary time and interruptions of this time with physical activities affect resting fat oxidation, an important variable of metabolic health, is not known.
In this context, the aim of this study is to comparatively determine the relationship between physical activity levels, sedentary behaviors, habitual diet, and resting fat oxidation in normal-weight and overweight/obese women. A total of 118 healthy women aged 25-50 years (normal weight, n=60; body mass index (BMI) = 18.5 - 24.9 kg/m²) and overweight/obese (n=60; BMI = 25.0 - 34.9 kg/m²) will participate in this study. All participants' body composition and resting metabolic rate measurements will be conducted, and fat and carbohydrate oxidation will be determined. The dietary habits, 4-day physical activity levels, and sedentary behaviors of all participants will be assessed using appropriate measurement methods.
The findings of this project are expected to reveal the extent to which dietary habits, physical activity, and sedentary behavior throughout the day affect resting fat oxidation in overweight/obese and normal-weight individuals. These findings will provide important evidence on how dietary habits and sedentary behaviors can improve resting fat oxidation, an important indicator of metabolic flexibility, without the need for dietary and exercise interventions
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1. Women with Overweight and Obesity (25.0-34.9 BMI) | – | –Healthy women with overweight and women without any chronic conditions other than obesity In this cross-sectional study, indirect calorimetry will be used to determine resting fat oxidation in these participants. Subsequently, the relationship between the resting fat oxidation data obtained with the habitual diet and physical activity status of these participants will be evaluated. Dietary patterns and physical activity will be assessed with 4 consecutive daily food consumption records and Actigraph GT3X+ devices, respectively. |
| 2. Women with normal weight (18.5-24.9 BMI) | – | –Healthy women with normal weight. In this cross-sectional study, indirect calorimetry will be used to determine resting fat oxidation in these participants. Thus, resting fat oxidation data of healthy women with normal weight and women with obesity/overweight will be compared. Subsequently, the relationship between the resting fat oxidation data obtained with the habitual diet and physical activity status of these participants will be evaluated. Dietary patterns and physical activity will be assessed with 4 consecutive daily food consumption records and Actigraph GT3X+ devices, respectively. |
Who may qualify
- Ages
- 25 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Sedentary women aged 25 to 50 with a body mass index range of 18.5-24.9 kg/m2 (normal weight; control group) and 25-34.9 kg/m2 (overweight and obese; research group) will be included in the study.
Key inclusion criteria (1 listed)
- Sedentary women aged 25-50 years with a body mass index range of 18.5-24.9 kg/m2 (normal weight) and 25-34.9 kg/m2 (overweight and obese) will be included in the study.
Key exclusion criteria (7 listed)
- Smokers,
- Taking any medication or supplements that may affect metabolism,
- Dieting for more than 6 months,
- Pregnant or breastfeeding,
- Amenorrhoea,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Resting fat oxidation
Time frame: From July 2024 to October 2024
In order to determine the relationship of dietary habits and habitual physical activity levels with resting fat oxidation in healthy overweight, obese and normal weight individuals, resting fat oxidation measurements will be performed with a indirect calorimetry (Cardio Pulmonary Exercise Testing, Quark CPET, Italy).All resting fat oxidation tests will be conducted in the same quiet room under a controlled ambient temperature (22-24 °C) and humidity (35-45%). Subjects will be instructed to arrive at the laboratory at 8 a.m. by car or by bus (avoiding any physical activity after waking up) and having fasted for at least 10-12 hours. In addition to this, they will be advised to avoid any moderate physical activity for the 24 h before the test day or any vigorous intensity exercise in the prior 48 h.
The relationship between habitual physical activity level and sedentary behaviour with resting fat oxidation
Time frame: July 2024- October 2024
Participants' habitual physical activity and sedentary behaviour will be measured with an accelerometer (Actigraph, USA) for 4 consecutive days to determine the relationship with resting fat oxidation.
Dietary pattern and fat oxidation
Time frame: July 2024- October 2024
In order to determine the relationship of macronutrient intake and food group consumption with resting fat oxidation, 4-day food consumption records will be obtained from the participants.
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 1 Jul 2024.
- Results publication: PubMed 28251936Fletcher G, Eves FF, Glover EI, Robinson SL, Vernooij CA, Thompson JL, Wallis GA. Dietary intake is independently associated with the maximal capacity for fat oxidation during exercise. Am J Clin Nutr. 2017 Apr;105(4):864-872. doi: 10.3945/ajcn.116.133520. Epub 2017 Mar 1.
- Results publication: PubMed 33549436Jurado-Fasoli L, Amaro-Gahete FJ, Merchan-Ramirez E, Labayen I, Ruiz JR. Relationships between diet and basal fat oxidation and maximal fat oxidation during exercise in sedentary adults. Nutr Metab Cardiovasc Dis. 2021 Apr 9;31(4):1087-1101. doi: 10.1016/j.numecd.2020.11.021. Epub 2020 Dec 1.
- Individual participant dataSharing planned: No. I can share my data when requested after the study is published.
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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.
Necip Demirci, MSc. study chair
Hacettepe University
Muhammed Atakan, Ph.D principal investigator
Hacettepe University
Zeynep Ergun, BSc study chair
Hacettepe University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity and Healthy, run by Hacettepe University at 1 site in Turkey (Türkiye).
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 1 inclusion and 7 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 1 Jul 2024. 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 Turkey (Türkiye). 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?
Resting fat oxidation (time frame: From July 2024 to October 2024). The study lists 3 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 NCT06476444, which also lists 2 linked publications.
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 1 Jul 2024.