ObesityBOD-BMATNCT07731438
Bone Marrow Adipose Tissue in Relation to Bone and Energy Metabolism in Obesity and Type 2 Diabetes Mellitus
A study testing Caloric Restriction in people with Obesity, run by General University Hospital, Prague at 3 sites in Czechia.
Trial summary
This interventional study is part of a broader research project entitled "Bone Marrow Adipose Tissue in Relation to Bone and Energy Metabolism in Obesity and Type 2 Diabetes Mellitus." The broader project includes both a cross-sectional study evaluating bone marrow adipose tissue and bone marrow mesenchymal stem cells… Read more about this study
- Who is it for?
- Ages 21 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Caloric Restriction
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 3 sitesCzechia
- Study dates
- 1 May 2023to 21 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 21 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Premenopausal women and age-eligible men assigned to either the obese intervention group or the lean control group
- Obese intervention group:
- Body mass index (BMI) of 30-42 kg/m²
- Fasting plasma glucose less than 6.4 mmol/L
- Age 25-55 years
- Lean control group:
Show all 9Show fewer
- BMI of 19-25 kg/m²
- Fasting plasma glucose less than 6.4 mmol/L
- Age 25-50 years
Who cannot join
- Diabetes mellitus
- Secondary osteoporosis
- History of severe neuropathic disease
- Hyperparathyroidism
- Hyperthyroidism
- Immobilization
Show all 34Show fewer
- Alcoholism
- Chronic gastrointestinal disease
- Significant chronic renal impairment, including any of the following:
- Chronic kidney disease
- Serum creatinine greater than 110 µmol/L
- Estimated glomerular filtration rate (eGFR) less than 1 mL/s/1.73 m²
- Proteinuria
- Diabetic nephropathy
- Chronic hepatic impairment
- Unstable cardiovascular disease
- Uncontrolled hypertension
- Current or recent use of any of the following medications:
- Bisphosphonates
- Estrogen
- Denosumab
- Gonadotropin-releasing hormone (GnRH) analogs
- Glucocorticoids at a dose equivalent to at least 5 mg of prednisone daily for at least 1 month
- Phenytoin
- Thiazolidinediones
- Insulin
- Adrenal or anabolic steroids
- Anticonvulsants
- Anticoagulants
- Pharmacological doses of vitamin D or vitamin A supplements
- Contraindications to magnetic resonance imaging (MRI), including:
- Pacemaker
- Metallic implants incompatible with MRI
- Claustrophobia
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Czechia3 sites, 3 recruiting
- Recruiting
General University Hospital in Prague
Prague, 12800
Ivan Raska, MD, Ph.D., +420224969280, ivan.raska@vfn.cz
Vit Zikan, MD, Ph.D., +420224969285, vit.zikan@vfn.cz
- Recruiting
Institute of Endocrinology, Prague, a state-funded organization established by the Ministry of Health of the Czech Republic.
Prague, 12800
Radka Taxova Braunerova, MD, Ph.D., +420 224 905 111, rbraunerova@endo.cz
Pavla Kalouskova, MD, +420 224 905 111, pkalouskova@endo.cz
- Recruiting
Institute of Physiology of the Czech Academy of Sciences
Prague, 14200
Michaela Tencerova, M.Sc., Ph.D., +420 241 062737, michaela.tencerova@fgu.cas.cz
Michaela Ferenčakova, +420 241 062737, michaela.ferencakova@fgu.cas.cz
About this study
Official title: Bone Marrow Adipose Tissue as a New Parameter in Relation to Bone and Energy Metabolism in Obesity and Type 2 Diabetes Mellitus
This interventional study is part of a broader research project entitled "Bone Marrow Adipose Tissue in Relation to Bone and Energy Metabolism in Obesity and Type 2 Diabetes Mellitus." The broader project includes both a cross-sectional study evaluating bone marrow adipose tissue and bone marrow mesenchymal stem cells in people with different metabolic and bone disorders and the present dietary intervention study.
The interventional study investigates whether caloric restriction changes bone marrow adipose tissue, bone health, whole-body metabolism, and the molecular and cellular characteristics of bone marrow mesenchymal stem cells in obese non-diabetic premenopausal women. A group of lean healthy premenopausal women will serve as a comparison group.
Read more
Participants in the intervention group will undergo an eight-week formula-based very-low-calorie diet using Cambridge Weight Plan products, providing approximately 2.5-3.35 MJ (600-800 kcal) per day, followed by a dietary weight-maintenance phase. Participants will receive nutritional counselling, and dietary adherence, body weight, physical activity, and clinical status will be monitored during scheduled study visits. Clinical and laboratory assessments will be conducted at baseline and after 2, 6, and 12 months.
Assessments will include magnetic resonance imaging and proton magnetic resonance spectroscopy of the lumbar spine to measure the amount and lipid composition of vertebral bone marrow adipose tissue. Bone mineral density and body composition will be measured using dual-energy X-ray absorptiometry, with particular attention to bone mineral density at the total hip and femoral neck. Additional measurements will include body weight, waist and hip circumference, body composition, physical activity, and fasting blood tests evaluating bone turnover, glucose and lipid metabolism, inflammatory markers, hormones, and adipokines.
Bone marrow aspirates and abdominal subcutaneous adipose tissue biopsies will be obtained at baseline and after six months. Bone marrow-derived and adipose tissue-derived mesenchymal stem cells will be examined for changes in cellular composition, gene-expression profiles, metabolic activity, oxidative stress, differentiation capacity, and senescence-related characteristics. Single-cell RNA sequencing will be used to characterize specific bone marrow mesenchymal stem cell subpopulations.
Bone marrow plasma and other biological samples will also undergo metabolomic, lipidomic, and proteomic profiling using high-resolution mass spectrometry. These analyses will be used to identify extracellular molecules and molecular patterns associated with glucose and lipid metabolism, inflammation, cellular senescence, and the response to caloric restriction.
The study aims to determine whether diet-induced weight loss can improve the bone marrow microenvironment and modify vertebral bone marrow fat, bone parameters, and the metabolic and senescent phenotype of mesenchymal stem cells. The findings may help identify imaging, cellular, and molecular markers of obesity-related bone fragility.
Read the detailed description
Bone marrow contains not only blood-forming cells but also adipose tissue and mesenchymal stromal cells that can develop into bone-forming cells or fat cells. Bone marrow adipose tissue (BMAT) is increasingly recognized as an active component of the bone marrow environment that may influence bone remodeling, skeletal strength, and whole-body metabolism. In people with obesity, fracture risk may be increased even when bone mineral density is normal or elevated. This suggests that changes in bone quality, bone marrow fat, and the function of bone marrow mesenchymal stromal cells (BM-MSCs) may contribute to obesity-related bone fragility.
The present application describes only the interventional study, which is part of a broader research project entitled "Bone Marrow Adipose Tissue in Relation to Bone and Energy Metabolism in Obesity and Type 2 Diabetes Mellitus." The broader project also includes a cross-sectional study evaluating BMAT and BM-MSC characteristics in participants with different metabolic and skeletal conditions. However, the cross-sectional component is not included in this application and is therefore not described further here.
The interventional study will investigate whether weight loss induced by caloric restriction modifies the bone marrow environment in obese non-diabetic premenopausal women. Lean healthy premenopausal women will serve as a comparison group. Participants in the intervention group will follow a formula-based very-low-calorie diet using Cambridge Weight Plan formula products, providing approximately 2.5-3.35 MJ (600-800 kcal) per day for 8 weeks. This will be followed by a 4-month low-calorie diet phase and subsequently by a weight-maintenance phase. Participants will receive nutritional counselling, and dietary adherence, body weight, physical activity, and clinical status will be monitored during scheduled study visits.
The study will evaluate whether the dietary intervention changes the amount and lipid composition of vertebral BMAT and whether these changes are associated with changes in bone and metabolic parameters. Vertebral BMAT will be assessed in the lumbar spine using magnetic resonance imaging and proton magnetic resonance spectroscopy. These methods allow non-invasive measurement of bone marrow fat content and assessment of its saturated and unsaturated lipid fractions.
Bone mineral density and body composition will be assessed using dual-energy X-ray absorptiometry, with particular attention to the total hip and femoral neck. Abdominal adipose tissue distribution will be evaluated using magnetic resonance imaging. Blood samples will be used to assess glucose and lipid metabolism, bone turnover, inflammatory markers, hormones, and adipokines.
Bone marrow aspirates and subcutaneous adipose tissue samples will be collected at baseline and after 6 months to study BM-MSCs and adipose tissue-derived mesenchymal stromal cells. Laboratory analyses will examine their cellular composition, ability to differentiate into bone-forming and fat cells, metabolic activity, oxidative stress, cellular senescence, gene-expression profiles, and other molecular characteristics. Single-cell RNA sequencing will be used to characterize specific BM-MSC subpopulations and identify transcriptional profiles associated with metabolic activity and cellular senescence.
Bone marrow plasma and other biological samples will also undergo metabolomic, lipidomic, and proteomic profiling to identify molecules associated with the bone marrow microenvironment, metabolic status, bone health, and the response to caloric restriction.
By integrating imaging, clinical, biochemical, cellular, and molecular data, the interventional study aims to determine whether diet-induced weight loss can improve the bone marrow environment and modify factors associated with obesity-related bone fragility. The findings may support the identification of new imaging, cellular, and molecular biomarkers of bone health and provide a scientific basis for future strategies to prevent or treat metabolic bone complications associated with obesity.
- Conditions
- Obesity
- Being tested
- Caloric Restriction
- Keywords
- Bone marrow adipose tissue, Obesity, Caloric Restriction, Energy Metabolism, Magnetic Resonance imaging, Proton Magnetic Resonance Spectroscopy, Bone marrow mesenchymal stem cells, Bone metabolism, Cellular senescence, Single-cell RNA sequencing, Diet-induced weight loss
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Caloric RestrictionBehavioural
Participants will follow a formula-based very-low-calorie diet (Cambridge Weight Plan) providing approximately 600-800 kcal per day (2.5-3.35 MJ per day) for 8 weeks. This will be followed by a 4-month low-calorie diet phase and subsequently by a weight-maintenance phase. Participants will receive nutritional counselling, and dietary adherence, body weight, physical activity, and clinical status will be monitored during scheduled study visits.
| Study group | Role | What they receive |
|---|---|---|
| Caloric Restriction Group | Experimental | Obese non-diabetic premenopausal women and age-eligible men will undergo an eight-week very-low-calorie formula diet followed by a weight-maintenance phase. Participants will receive nutritional counseling and undergo longitudinal clinical, anthropometric, biochemical, imaging, and cellular assessments to evaluate changes in vertebral bone marrow adipose tissue, bone mineral density, body composition, metabolic parameters, and the phenotype of bone marrow- and adipose tissue-derived mesenchymal stromal cells. Receives: Behavioral: Caloric Restriction |
| Lean Healthy Baseline Reference Group | No intervention | Lean healthy premenopausal women or age-eligible men will serve as a baseline reference group. Participants in this arm will not receive caloric restriction or any other study intervention and will not undergo longitudinal follow-up. Baseline assessments include clinical and anthropometric evaluation, blood sampling, bone mineral density and body composition measurements, magnetic resonance imaging and proton magnetic resonance spectroscopy of the lumbar spine, and collection of bone marrow and subcutaneous adipose tissue samples. Their baseline findings will be compared with those of participants with obesity. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Mean L2-L4 Vertebral Bone Marrow Adipose Tissue Proton Density Fat Fraction
Vertebral bone marrow adipose tissue proton density fat fraction will be measured in the L2, L3, and L4 vertebral bodies using the mDIXON Quant MRI sequence. The mean value across the three vertebral bodies will be reported as a percentage.
Measured: Baseline, Week 24, and Week 48
Change From Baseline in Mean L2-L4 Vertebral Bone Marrow Adipose Tissue Unsaturation Index
The lipid composition of vertebral bone marrow adipose tissue will be measured in the L2, L3, and L4 vertebral bodies using proton magnetic resonance spectroscopy. A prespecified unsaturation index will be calculated from the unsaturated and total lipid signals. The mean value across the three vertebral bodies will be reported.
Measured: Baseline, Week 24, and Week 48
Change from baseline in BM-MSC and AT-MSC potency, differentiation, senescence, and metabolic adaptation
Change from baseline to Week 24 in characteristics of bone marrow-derived mesenchymal stem cells (BM-MSCs) and adipose tissue-derived mesenchymal stem cells (AT-MSCs). Potency is assessed using the colony-forming unit-fibroblast (CFU-F) assay and proliferation rate. Osteogenic differentiation is assessed by alkaline phosphatase (ALP) activity and expression of ALPL and RUNX2; adipogenic differentiation is assessed by Nile Red staining and expression of ADIPOQ and LEP. Senescence is assessed by senescence-associated β-galactosidase activity and expression of p16INK4a and p21. Metabolic adaptation is assessed by extracellular flux analysis of mitochondrial respiration and glycolytic capacity and by insulin-signaling activation. For each parameter, the outcome is the change from baseline to Week 24, compared between BM-MSCs and AT-MSCs.
Measured: Baseline and Week 24
Secondary outcomes (4)
Change from baseline in metabolomic and lipidomic profile of bone marrow and plasma
Change from baseline to Week 24 in the metabolomic and lipidomic profiles of bone marrow and plasma. Untargeted and targeted liquid chromatography-mass spectrometry (LC-MS) analyses assess amino acids, organic acids, nucleotides, and intermediates of central carbon metabolism. LC-MS lipidomic analysis assesses fatty acids, phospholipids, sphingolipids, triacylglycerols, and diacylglycerols. For each metabolite and lipid species, the outcome is the change in concentration from baseline to Week 24, compared between bone marrow and plasma.
Measured: Baseline and Week 24
Change From Baseline in Total Hip Bone Mineral Density
Areal bone mineral density of the total hip will be measured by dual-energy X-ray absorptiometry using a Hologic Horizon A densitometer. Bone mineral density will be reported in grams per square centimeter. Change from baseline will be calculated at Week 24 and Week 48.
Measured: Baseline, Week 24, and Week 48
Change From Baseline in Lumbar Spine Bone Mineral Density
Areal bone mineral density of the lumbar spine (L1-L4) will be measured by dual-energy X-ray absorptiometry using a Hologic Horizon A densitometer. Bone mineral density will be reported in grams per square centimeter. Change from baseline will be calculated at Week 24 and Week 48.
Measured: Baseline, Week 24, and Week 48
Change From Baseline in Femoral Neck Bone Mineral Density
Areal bone mineral density of the femoral neck will be measured by dual-energy X-ray absorptiometry using a Hologic Horizon A densitometer. Bone mineral density will be reported in grams per square centimeter.
Measured: Baseline, Week 24, and Week 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2026
- Study start1 May 2023
- Primary completion1 Nov 2026 (estimated)
- Study completion21 Jan 2027 (estimated)
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 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- This is a non-randomized, parallel-group study. Obese non-diabetic premenopausal women age-eligible men undergo an eight-week very low-calorie dietary intervention followed by a weight-maintenance phase. Lean healthy premenopausal women and age-eligible men serve as a non-interventional reference group and are assessed at baseline only, without longitudinal follow-up.
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- General University Hospital, Prague
- Sponsor type
- University, hospital or other
- Collaborators
- Czech Academy of Sciences, Ministry of Health, Czech Republic
- Responsible party
- Principal investigator, Vit Zikan, General University Hospital, Prague
- Investigators
- Michaela Tencerova, MSc, PhD, Principal investigator, Institute of Physiology of the Czech Academy of Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07731438
- Sponsor's protocol ID
- NU23-01 00125
- Acronym
- BOD-BMAT
- Status last verified
- Jul 2026
- First submitted
- 16 Jul 2026
- Last updated
- 28 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data underlying the published results will be shared with qualified researchers upon reasonable request, subject to ethical approval and applicable data-protection requirements.
Publications
Tencerova M, Frost M, Figeac F, Nielsen TK, Ali D, Lauterlein JL, Andersen TL, Haakonsson AK, Rauch A, Madsen JS, Ejersted C, Hojlund K, Kassem M. Obesity-Associated Hypermetabolism and Accelerated Senescence of Bone Marrow Stromal Stem Cells Suggest a Potential Mechanism for Bone Fragility. Cell Rep. 2019 May 14;27(7):2050-2062.e6. doi: 10.1016/j.celrep.2019.04.066.
PubMed 31091445
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bone Marrow Adipose Tissue as a New Parameter in Relation to Bone and Energy Metabolism in Obesity and Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT07731438
- Acronym / sponsor ID
- BOD-BMAT / NU23-01 00125
- Conditions
- Obesity
- Keywords
- Bone marrow adipose tissue, Obesity, Caloric Restriction, Energy Metabolism, Magnetic Resonance imaging, Proton Magnetic Resonance Spectroscopy, Bone marrow mesenchymal stem cells, Bone metabolism
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- General University Hospital, PragueUniversity, hospital or other
- Collaborators
- Czech Academy of Sciences, Ministry of Health, Czech Republic
- Study start
- 1 May 2023 (actual)
- Primary completion
- 1 Nov 2026 (estimated)
- Study completion
- 21 Jan 2027 (estimated)
- First posted
- 28 Jul 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 interventional study is part of a broader research project entitled "Bone Marrow Adipose Tissue in Relation to Bone and Energy Metabolism in Obesity and Type 2 Diabetes Mellitus." The broader project includes both a cross-sectional study evaluating bone marrow adipose tissue and bone marrow mesenchymal stem cells in people with different metabolic and bone disorders and the present dietary intervention study.
The interventional study investigates whether caloric restriction changes bone marrow adipose tissue, bone health, whole-body metabolism, and the molecular and cellular characteristics of bone marrow mesenchymal stem cells in obese non-diabetic premenopausal women. A group of lean healthy premenopausal women will serve as a comparison group.
Participants in the intervention group will undergo an eight-week formula-based very-low-calorie diet using Cambridge Weight Plan products, providing approximately 2.5-3.35 MJ (600-800 kcal) per day, followed by a dietary weight-maintenance phase. Participants will receive nutritional counselling, and dietary adherence, body weight, physical activity, and clinical status will be monitored during scheduled study visits. Clinical and laboratory assessments will be conducted at baseline and after 2, 6, and 12 months.
Assessments will include magnetic resonance imaging and proton magnetic resonance spectroscopy of the lumbar spine to measure the amount and lipid composition of vertebral bone marrow adipose tissue. Bone mineral density and body composition will be measured using dual-energy X-ray absorptiometry, with particular attention to bone mineral density at the total hip and femoral neck. Additional measurements will include body weight, waist and hip circumference, body composition, physical activity, and fasting blood tests evaluating bone turnover, glucose and lipid metabolism, inflammatory markers, hormones, and adipokines.
Bone marrow aspirates and abdominal subcutaneous adipose tissue biopsies will be obtained at baseline and after six months. Bone marrow-derived and adipose tissue-derived mesenchymal stem cells will be examined for changes in cellular composition, gene-expression profiles, metabolic activity, oxidative stress, differentiation capacity, and senescence-related characteristics. Single-cell RNA sequencing will be used to characterize specific bone marrow mesenchymal stem cell subpopulations.
Bone marrow plasma and other biological samples will also undergo metabolomic, lipidomic, and proteomic profiling using high-resolution mass spectrometry. These analyses will be used to identify extracellular molecules and molecular patterns associated with glucose and lipid metabolism, inflammation, cellular senescence, and the response to caloric restriction.
The study aims to determine whether diet-induced weight loss can improve the bone marrow microenvironment and modify vertebral bone marrow fat, bone parameters, and the metabolic and senescent phenotype of mesenchymal stem cells. The findings may help identify imaging, cellular, and molecular markers of obesity-related bone fragility.
Detailed description
Bone marrow contains not only blood-forming cells but also adipose tissue and mesenchymal stromal cells that can develop into bone-forming cells or fat cells. Bone marrow adipose tissue (BMAT) is increasingly recognized as an active component of the bone marrow environment that may influence bone remodeling, skeletal strength, and whole-body metabolism. In people with obesity, fracture risk may be increased even when bone mineral density is normal or elevated. This suggests that changes in bone quality, bone marrow fat, and the function of bone marrow mesenchymal stromal cells (BM-MSCs) may contribute to obesity-related bone fragility.
The present application describes only the interventional study, which is part of a broader research project entitled "Bone Marrow Adipose Tissue in Relation to Bone and Energy Metabolism in Obesity and Type 2 Diabetes Mellitus." The broader project also includes a cross-sectional study evaluating BMAT and BM-MSC characteristics in participants with different metabolic and skeletal conditions. However, the cross-sectional component is not included in this application and is therefore not described further here.
The interventional study will investigate whether weight loss induced by caloric restriction modifies the bone marrow environment in obese non-diabetic premenopausal women. Lean healthy premenopausal women will serve as a comparison group. Participants in the intervention group will follow a formula-based very-low-calorie diet using Cambridge Weight Plan formula products, providing approximately 2.5-3.35 MJ (600-800 kcal) per day for 8 weeks. This will be followed by a 4-month low-calorie diet phase and subsequently by a weight-maintenance phase. Participants will receive nutritional counselling, and dietary adherence, body weight, physical activity, and clinical status will be monitored during scheduled study visits.
The study will evaluate whether the dietary intervention changes the amount and lipid composition of vertebral BMAT and whether these changes are associated with changes in bone and metabolic parameters. Vertebral BMAT will be assessed in the lumbar spine using magnetic resonance imaging and proton magnetic resonance spectroscopy. These methods allow non-invasive measurement of bone marrow fat content and assessment of its saturated and unsaturated lipid fractions.
Bone mineral density and body composition will be assessed using dual-energy X-ray absorptiometry, with particular attention to the total hip and femoral neck. Abdominal adipose tissue distribution will be evaluated using magnetic resonance imaging. Blood samples will be used to assess glucose and lipid metabolism, bone turnover, inflammatory markers, hormones, and adipokines.
Bone marrow aspirates and subcutaneous adipose tissue samples will be collected at baseline and after 6 months to study BM-MSCs and adipose tissue-derived mesenchymal stromal cells. Laboratory analyses will examine their cellular composition, ability to differentiate into bone-forming and fat cells, metabolic activity, oxidative stress, cellular senescence, gene-expression profiles, and other molecular characteristics. Single-cell RNA sequencing will be used to characterize specific BM-MSC subpopulations and identify transcriptional profiles associated with metabolic activity and cellular senescence.
Bone marrow plasma and other biological samples will also undergo metabolomic, lipidomic, and proteomic profiling to identify molecules associated with the bone marrow microenvironment, metabolic status, bone health, and the response to caloric restriction.
By integrating imaging, clinical, biochemical, cellular, and molecular data, the interventional study aims to determine whether diet-induced weight loss can improve the bone marrow environment and modify factors associated with obesity-related bone fragility. The findings may support the identification of new imaging, cellular, and molecular biomarkers of bone health and provide a scientific basis for future strategies to prevent or treat metabolic bone complications associated with obesity.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a non-randomized, parallel-group study. Obese non-diabetic premenopausal women age-eligible men undergo an eight-week very low-calorie dietary intervention followed by a weight-maintenance phase. Lean healthy premenopausal women and age-eligible men serve as a non-interventional reference group and are assessed at baseline only, without longitudinal follow-up.
| Arm | Type | Receives |
|---|---|---|
| Caloric Restriction Group | Experimental | Behavioral: Caloric RestrictionObese non-diabetic premenopausal women and age-eligible men will undergo an eight-week very-low-calorie formula diet followed by a weight-maintenance phase. Participants will receive nutritional counseling and undergo longitudinal clinical, anthropometric, biochemical, imaging, and cellular assessments to evaluate changes in vertebral bone marrow adipose tissue, bone mineral density, body composition, metabolic parameters, and the phenotype of bone marrow- and adipose tissue-derived mesenchymal stromal cells. |
| Lean Healthy Baseline Reference Group | No intervention | –Lean healthy premenopausal women or age-eligible men will serve as a baseline reference group. Participants in this arm will not receive caloric restriction or any other study intervention and will not undergo longitudinal follow-up. Baseline assessments include clinical and anthropometric evaluation, blood sampling, bone mineral density and body composition measurements, magnetic resonance imaging and proton magnetic resonance spectroscopy of the lumbar spine, and collection of bone marrow and subcutaneous adipose tissue samples. Their baseline findings will be compared with those of participants with obesity. |
Who may qualify
- Ages
- 21 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Premenopausal women and age-eligible men assigned to either the obese intervention group or the lean control group
- Obese intervention group:
- Body mass index (BMI) of 30-42 kg/m²
- Fasting plasma glucose less than 6.4 mmol/L
- Age 25-55 years
Key exclusion criteria (34 listed)
- Diabetes mellitus
- Secondary osteoporosis
- History of severe neuropathic disease
- Hyperparathyroidism
- Hyperthyroidism
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 |
|---|---|---|
| Caloric RestrictionParticipants will follow a formula-based very-low-calorie diet (Cambridge Weight Plan) providing approximately 600-800 kcal per day (2.5-3.35 MJ per day) for 8 weeks. This will be followed by a 4-month low-calorie diet phase and subsequently by a weight-maintenance phase. Participants will receive nutritional counselling, and dietary adherence, body weight, physical activity, and clinical status will be monitored during scheduled study visits. | Behavioural | Caloric Restriction Group |
Primary outcome
Change From Baseline in Mean L2-L4 Vertebral Bone Marrow Adipose Tissue Proton Density Fat Fraction
Time frame: Baseline, Week 24, and Week 48
Vertebral bone marrow adipose tissue proton density fat fraction will be measured in the L2, L3, and L4 vertebral bodies using the mDIXON Quant MRI sequence. The mean value across the three vertebral bodies will be reported as a percentage.
Change From Baseline in Mean L2-L4 Vertebral Bone Marrow Adipose Tissue Unsaturation Index
Time frame: Baseline, Week 24, and Week 48
The lipid composition of vertebral bone marrow adipose tissue will be measured in the L2, L3, and L4 vertebral bodies using proton magnetic resonance spectroscopy. A prespecified unsaturation index will be calculated from the unsaturated and total lipid signals. The mean value across the three vertebral bodies will be reported.
Change from baseline in BM-MSC and AT-MSC potency, differentiation, senescence, and metabolic adaptation
Time frame: Baseline and Week 24
Change from baseline to Week 24 in characteristics of bone marrow-derived mesenchymal stem cells (BM-MSCs) and adipose tissue-derived mesenchymal stem cells (AT-MSCs). Potency is assessed using the colony-forming unit-fibroblast (CFU-F) assay and proliferation rate. Osteogenic differentiation is assessed by alkaline phosphatase (ALP) activity and expression of ALPL and RUNX2; adipogenic differentiation is assessed by Nile Red staining and expression of ADIPOQ and LEP. Senescence is assessed by senescence-associated β-galactosidase activity and expression of p16INK4a and p21. Metabolic adaptation is assessed by extracellular flux analysis of mitochondrial respiration and glycolytic capacity and by insulin-signaling activation. For each parameter, the outcome is the change from baseline to Week 24, compared between BM-MSCs and AT-MSCs.
4 secondary outcomes
Change from baseline in metabolomic and lipidomic profile of bone marrow and plasma
Time frame: Baseline and Week 24
Change From Baseline in Total Hip Bone Mineral Density
Time frame: Baseline, Week 24, and Week 48
Change From Baseline in Lumbar Spine Bone Mineral Density
Time frame: Baseline, Week 24, and Week 48
Change From Baseline in Femoral Neck Bone Mineral Density
Time frame: Baseline, Week 24, and Week 48
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2026.
- Background: PubMed 31091445Tencerova M, Frost M, Figeac F, Nielsen TK, Ali D, Lauterlein JL, Andersen TL, Haakonsson AK, Rauch A, Madsen JS, Ejersted C, Hojlund K, Kassem M. Obesity-Associated Hypermetabolism and Accelerated Senescence of Bone Marrow Stromal Stem Cells Suggest a Potential Mechanism for Bone Fragility. Cell Rep. 2019 May 14;27(7):2050-2062.e6. doi: 10.1016/j.celrep.2019.04.066.
- Individual participant dataSharing planned: Yes. De-identified individual participant data underlying the published results will be shared with qualified researchers upon reasonable request, subject to ethical approval and applicable data-protection requirements.
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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.
Michaela Tencerova, MSc, PhD principal investigator
Institute of Physiology of the Czech Academy of Sciences
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Caloric Restriction in people with Obesity, run by General University Hospital, Prague at 3 sites in Czechia.
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 9 inclusion and 34 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: looking for participants now, as of the sponsor's last update on 28 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Czechia. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Vit Zikan, MD, Ph.D. (+420731670425, vit.zikan@vfn.cz), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in Mean L2-L4 Vertebral Bone Marrow Adipose Tissue Proton Density Fat Fraction (time frame: Baseline, Week 24, and Week 48). 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 NCT07731438, 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 28 Jul 2026.