ObesityNCT07858877
Effects of Different Exercise Intensities on Lac-Phe Levels in Women With Obesity
A study testing High-Intensity Interval Training and Moderate-Intensity Continuous Training in people with Obesity, run by Istanbul Gelisim University at 1 site in Turkey (Türkiye).
Trial summary
This study will investigate how different exercise intensities affect blood levels of lactoyl-phenylalanine (Lac-Phe), a metabolite that may be involved in the regulation of appetite and energy balance, in women with obesity. Read more about this study
- Who is it for?
- Ages 30 to 50 years, women only
- Conditions the study is for
- Obesity
- What is being tested?
- High-Intensity Interval Training and Moderate-Intensity Continuous Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 22 Mar 2023to 5 Jul 2023
- 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 30 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Female participants aged 30 to 50 years. Body mass index (BMI) between 30.0 and 34.9 kg/m² (class I obesity). No known cardiovascular or metabolic disease. Not using medications regularly. No orthopedic condition that would prevent participation in exercise. Non-smoker. Sedentary, defined as performing less than 150 minutes of moderate-intensity or less than 75 minutes of vigorous-intensity physical activity per week.
- Not pregnant. Premenopausal. Residing in Denizli and able to remain in Denizli throughout the study period. Having regular menstrual cycles. Follicle-stimulating hormone (FSH) level <24 IU/L.
Who cannot join
- Change in habitual physical activity level during the study period. Significant change in dietary habits, including daily caloric or macronutrient intake, during the study period.
- Failure to continue meeting any of the study inclusion criteria. Missing three consecutive scheduled exercise sessions. Failure or refusal to provide the required blood samples during the study.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul Gelisim University
Istanbul, Istanbul, 34720
About this study
Official title: Effects of 12 Weeks of Different Exercise Intensities on Lac-Phe Levels in Women With Obesity
This study will investigate how different exercise intensities affect blood levels of lactoyl-phenylalanine (Lac-Phe), a metabolite that may be involved in the regulation of appetite and energy balance, in women with obesity. Participants aged 30 to 50 years with a body mass index (BMI) of 30-34.9 kg/m² will be assigned to one of three groups: high-intensity interval training (HIIT), moderate-intensity continuous training (MICT), or a control group. The exercise programs will be performed for 12 weeks. EtikBasvuruFormu DUYGU Blood samples and clinical measurements will be collected before and after the study period. The study will evaluate changes in Lac-Phe and related biochemical markers, including lactate, phenylalanine, and CNDP2, together with selected metabolic, body composition, physical activity, and appetite-related measures. The main aim is to determine whether exercise intensity influences Lac-Phe responses and whether these changes are associated with metabolic and appetite-related outcomes in women with obesity.
- Conditions
- Obesity
- Being tested
- High-Intensity Interval Training, Moderate-Intensity Continuous Training
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-Intensity Interval TrainingBehavioural
A 12-week supervised interval walking program performed three times per week. Participants perform repeated 1-minute bouts of fast walking at 80-90% of maximal heart rate followed by 1-minute recovery walking periods at approximately 50% of maximal heart rate, repeated for 12 cycles. Heart rate and rating of perceived exertion are monitored throughout the sessions.
Moderate-Intensity Continuous TrainingBehavioural
A 12-week supervised continuous walking program performed three times per week. Participants exercise continuously for approximately 40 minutes at 65-70% of maximal heart rate. Heart rate and rating of perceived exertion are monitored during each session.
| Study group | Role | What they receive |
|---|---|---|
| High-Intensity Interval Training Group | Experimental | Participants will perform a high-intensity interval training program for 12 weeks, three sessions per week. The protocol consists of repeated 1-minute periods of fast walking at 80-90% of maximal heart rate, followed by 1-minute periods of walking at approximately 50% of maximal heart rate. This cycle will be repeated 12 times during each exercise session. Heart rate and perceived exertion will be monitored during exercise. Receives: Behavioral: High-Intensity Interval Training |
| Moderate-Intensity Continuous Training Group | Active comparator | Participants will perform moderate-intensity continuous walking exercise for 12 weeks, three sessions per week. Exercise will be performed continuously at approximately 65-70% of maximal heart rate for about 40 minutes per session. Heart rate and perceived exertion will be monitored during exercise. Receives: Behavioral: Moderate-Intensity Continuous Training |
| Control Group | No intervention | Participants in the control group will not receive a structured exercise intervention during the 12-week study period and will be asked to maintain their usual lifestyle and dietary habits. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Serum Lactoyl-Phenylalanine (Lac-Phe) Level
Serum lactoyl-phenylalanine (Lac-Phe) levels will be measured from blood samples collected before and after the 12-week intervention period. The change in circulating Lac-Phe levels will be compared among the high-intensity interval training, moderate-intensity continuous training, and control groups to determine the effect of exercise intensity.
Measured: Baseline and 12 weeks
Secondary outcomes (4)
Change in Serum Lactate Level
Serum lactate levels will be determined from blood samples collected before and after the intervention. Changes in lactate levels will be compared among the three study groups to evaluate the metabolic response to different exercise intensities.
Measured: Baseline and 12 weeks
Change in Serum Phenylalanine Level
Serum phenylalanine concentrations will be assessed in blood samples obtained before and after the 12-week intervention. The change in phenylalanine concentration will be compared among the high-intensity interval training, moderate-intensity continuous training, and control groups.
Measured: Baseline and 12 weeks
Change in Serum CNDP2 Level
Serum cytosolic nonspecific dipeptidase 2 (CNDP2) levels will be measured before and after the intervention using an enzyme-linked immunosorbent assay (ELISA). Changes in CNDP2 levels will be compared among the three study groups.
Measured: Baseline and 12 weeks
Change in CNDP2 Gene Expression
CNDP2 gene expression will be assessed from blood samples using RNA isolation, complementary DNA synthesis, and real-time polymerase chain reaction (RT-PCR). Pre- to post-intervention changes in CNDP2 expression will be compared among the study groups.
Measured: Baseline and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2026
- Study start22 Mar 2023
- Primary completion5 Jul 2023
- Study completion5 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Gelisim University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Görkem Açar, Istanbul Gelisim University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07858877
- Sponsor's protocol ID
- LACPHE-EX-2023-01
- Status last verified
- Sep 2026
- First submitted
- 29 Sep 2026
- Last updated
- 5 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of 12 Weeks of Different Exercise Intensities on Lac-Phe Levels in Women With Obesity
- ClinicalTrials.gov ID
- NCT07858877
- Acronym / sponsor ID
- LACPHE-EX-2023-01
- Conditions
- Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Istanbul Gelisim UniversityUniversity, hospital or other
- Study start
- 22 Mar 2023 (actual)
- Primary completion
- 5 Jul 2023 (actual)
- Study completion
- 5 Jul 2023 (actual)
- First posted
- 5 Oct 2026 (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.
This study will investigate how different exercise intensities affect blood levels of lactoyl-phenylalanine (Lac-Phe), a metabolite that may be involved in the regulation of appetite and energy balance, in women with obesity. Participants aged 30 to 50 years with a body mass index (BMI) of 30-34.9 kg/m² will be assigned to one of three groups: high-intensity interval training (HIIT), moderate-intensity continuous training (MICT), or a control group. The exercise programs will be performed for 12 weeks. EtikBasvuruFormu DUYGU Blood samples and clinical measurements will be collected before and after the study period. The study will evaluate changes in Lac-Phe and related biochemical markers, including lactate, phenylalanine, and CNDP2, together with selected metabolic, body composition, physical activity, and appetite-related measures. The main aim is to determine whether exercise intensity influences Lac-Phe responses and whether these changes are associated with metabolic and appetite-related outcomes in women with obesity.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| High-Intensity Interval Training Group | Experimental | Behavioral: High-Intensity Interval TrainingParticipants will perform a high-intensity interval training program for 12 weeks, three sessions per week. The protocol consists of repeated 1-minute periods of fast walking at 80-90% of maximal heart rate, followed by 1-minute periods of walking at approximately 50% of maximal heart rate. This cycle will be repeated 12 times during each exercise session. Heart rate and perceived exertion will be monitored during exercise. |
| Moderate-Intensity Continuous Training Group | Active comparator | Behavioral: Moderate-Intensity Continuous TrainingParticipants will perform moderate-intensity continuous walking exercise for 12 weeks, three sessions per week. Exercise will be performed continuously at approximately 65-70% of maximal heart rate for about 40 minutes per session. Heart rate and perceived exertion will be monitored during exercise. |
| Control Group | No intervention | –Participants in the control group will not receive a structured exercise intervention during the 12-week study period and will be asked to maintain their usual lifestyle and dietary habits. |
Who may qualify
- Ages
- 30 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Female participants aged 30 to 50 years. Body mass index (BMI) between 30.0 and 34.9 kg/m² (class I obesity). No known cardiovascular or metabolic disease. Not using medications regularly. No orthopedic condition that would prevent participation in exercise. Non-smoker. Sedentary, defined as performing less than 150 minutes of moderate-intensity or less than 75 minutes of vigorous-intensity physical activity per week.
- Not pregnant. Premenopausal. Residing in Denizli and able to remain in Denizli throughout the study period. Having regular menstrual cycles. Follicle-stimulating hormone (FSH) level <24 IU/L.
Key exclusion criteria (2 listed)
- Change in habitual physical activity level during the study period. Significant change in dietary habits, including daily caloric or macronutrient intake, during the study period.
- Failure to continue meeting any of the study inclusion criteria. Missing three consecutive scheduled exercise sessions. Failure or refusal to provide the required blood samples during the study.
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 |
|---|---|---|
| High-Intensity Interval TrainingA 12-week supervised interval walking program performed three times per week. Participants perform repeated 1-minute bouts of fast walking at 80-90% of maximal heart rate followed by 1-minute recovery walking periods at approximately 50% of maximal heart rate, repeated for 12 cycles. Heart rate and rating of perceived exertion are monitored throughout the sessions. | Behavioural | High-Intensity Interval Training Group |
| Moderate-Intensity Continuous TrainingA 12-week supervised continuous walking program performed three times per week. Participants exercise continuously for approximately 40 minutes at 65-70% of maximal heart rate. Heart rate and rating of perceived exertion are monitored during each session. | Behavioural | Moderate-Intensity Continuous Training Group |
Primary outcome
Change in Serum Lactoyl-Phenylalanine (Lac-Phe) Level
Time frame: Baseline and 12 weeks
Serum lactoyl-phenylalanine (Lac-Phe) levels will be measured from blood samples collected before and after the 12-week intervention period. The change in circulating Lac-Phe levels will be compared among the high-intensity interval training, moderate-intensity continuous training, and control groups to determine the effect of exercise intensity.
4 secondary outcomes
Change in Serum Lactate Level
Time frame: Baseline and 12 weeks
Change in Serum Phenylalanine Level
Time frame: Baseline and 12 weeks
Change in Serum CNDP2 Level
Time frame: Baseline and 12 weeks
Change in CNDP2 Gene Expression
Time frame: Baseline and 12 weeks
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 5 Oct 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High-Intensity Interval Training and Moderate-Intensity Continuous Training in people with Obesity, run by Istanbul Gelisim 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 2 inclusion and 2 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 5 Oct 2026. 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?
Change in Serum Lactoyl-Phenylalanine (Lac-Phe) Level (time frame: Baseline and 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Oct 2026.