Obesity & Overweight4FATNCT07456124
Weight Loss and Adipose Tissue Metabolism During Conservative Treatment of Obesity
An observational study of Obesity & Overweight and Obesity (Disorder), run by University of Helsinki.
Trial summary
This prospective observational study investigates weight loss and metabolic changes in adults with obesity undergoing standard clinical diet-induced lifestyle treatment and counseling. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obesity & Overweight, Obesity (Disorder)
- What is being tested?
- Diet-Induced Weight Loss Program
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 22 participants
- Where
- No sites listed yet
- Study dates
- 19 Aug 2014to 17 Aug 2016
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients seeking treatment for obesity at Helsinki University Central Hospital and affiliated outpatient obesity clinics.
Who may be able to join
- Age ≥18 years
- BMI ≥28 kg/m²
- Seeking treatment for obesity at Helsinki University Central Hospital or affiliated units
Who cannot join
- Pregnancy or lactation
- Current smoking
- Anemia (Hb <130 g/L in men; <120 g/L in women)
- Severe comorbid disease or condition judged by investigator to compromise safety
- Contraindications to MRI (e.g., metal implants, claustrophobia)
About this study
Official title: Adipose Tissue Metabolism in Obesity and Diet-Induced Weight Loss: A Prospective Observational Study of Body Weight, Fat Distribution, and Tissue-Specific Metabolic Adaptations
This prospective observational study investigates weight loss and metabolic changes in adults with obesity undergoing standard clinical diet-induced lifestyle treatment and counseling. Participants follow a very-low-calorie diet followed by a conventional weight loss diet in addition to lifestyle counseling and are followed for 12 months. The study examines weight loss as the primary outcome and characterizes changes in body composition, fat distribution, glucose metabolism, inflammation, and adipose tissue biology as secondary outcomes.
Read the detailed description
Obesity is associated with metabolic complications including insulin resistance, fatty liver disease, dyslipidaemia, and systemic inflammation. Weight loss can improve these complications, yet individuals vary widely in weight loss, fat distribution and metabolic response. Subcutaneous adipose tissue dysfunction, including impaired mitochondrial biogenesis and increased inflammation, is thought to play a central role.
This prospective observational study follows adults with obesity undergoing standard-of-care diet and lifestyle treatment at Helsinki University Central Hospital, Helsinki, Finland. The intervention consists of a very-low-calorie diet for approximately 10 weeks, followed by gradual transition to a conventional weight loss diet and multidisciplinary clinical follow-up.
Assessments are performed at baseline, 6 months, and 12 months and include anthropometry, body composition (BIA, DXA), fasting blood samples, and oral glucose tolerance testing. Subcutaneous adipose tissue biopsies are obtained from four anatomical depots (gluteal, abdominal, breast, and upper arm) for molecular, mitochondrial, epigenetic, and histological analyses.
The primary outcome is diet-induced weight loss over 12 months. Secondary outcomes include changes in fat distribution, insulin sensitivity, lipid profile, inflammation, mitochondrial measures in adipose tissue, and depot-specific adipose tissue characteristics.
- Conditions
- Obesity & Overweight, Obesity (Disorder)
- Being tested
- Diet-Induced Weight Loss Program
- Keywords
- Weight loss, obesity, adipose tissue, inflammation, mitochondria, metabolism, conservative treatment of obesity, lifestyle intervention of obesity
- Medical subject headings
- Obesity, Overweight, Weight Loss, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diet-Induced Weight Loss ProgramBehavioural
Standard clinical obesity treatment consisting of a very-low-calorie diet for approximately 10 weeks followed by transition to a conventional weight loss diet with multidisciplinary clinical follow-up.
| Study group | Role | What they receive |
|---|---|---|
| Diet-Induced Weight Loss Cohort | Adults with obesity undergoing standard clinical diet treatment including a very-low-calorie diet followed by transition to a conventional weight loss diet and lifestyle counseling Receives: Behavioral: Diet-Induced Weight Loss Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Total Body Weight Loss (%TWL)
Percentage change in body weight from baseline, calculated as 100 × (baseline weight - follow-up weight) / baseline weight
Measured: Baseline to 6 months
Secondary outcomes (14)
Change in Body Weight (kg)
Absolute change in body weight measured in kilograms (kg). Reported as mean change from baseline.
Measured: Baseline to 6 and to 12 months
Change in Total Body Fat Mass (kg)
Change in total body fat mass measured by body impedance analysis (BIA). Reported as mean change from baseline (kg).
Measured: Baseline to 6 months and to 12 months
Change in Body Fat percentage (%)
Change in fat percentage measured by body impedance analysis (BIA). Reported as mean change from baseline (%).
Measured: Baseline to 6 and to 12 months
Change in Plasma Glycated Hemoglobin (HbA1c)
HbA1c plasma glycated hemoglogin measured in SI units mmol/mol, Reported as mean change from baseline.
Measured: Baseline to 6 months and to 12 months
Change in HOMA-IR (Homeostatic Model Assessment of Insulin Resistance)
HOMA-IR calculated as fasting glucose (mmol/L) × fasting insulin (mU/L) / 22.5. Reported as mean change from baseline.
Measured: Baseline to 6 and to 12 months
Change in Plasma Total Cholesterol (mmol/L)
Change in Plasma Total Cholesterol (mmol/L), Reported as mean change from baseline.
Measured: Baseline to 6 months and to 12 months
Change in Plasma LDL Cholesterol (mmol/L)
Change in Plasma LDL Cholesterol (mmol/L). Reported as mean change from baseline.
Measured: Baseline to 6 months and to 12 months
Change in Plasma HDL Cholesterol (mmol/L)
Change in HDL Cholesterol (mmol/L). Reported as mean change from baseline.
Measured: Baseline to 6 months and to 12 months
Change in Plasma Triglycerides (mmol/L)
Change in Plasma Triglycerides (mmol/L). Reported as mean change from baseline.
Measured: Baseline to 6 months and to 12 months
Change in Plasma C-Reactive Protein Concentration (mg/L)
Change in Plasma high-sensitivity C-Reactive Protein Concentration (hs-CRP, mg/L). Reported as mean change from baseline.
Measured: Baseline, to 6 months and to 12 months
Change in Mitochondrial DNA amount in Subcutaneous Abdominal Adipose Tissue
Change in Mitochondrial DNA Amount in Subcutaneous Abdominal Adipose Tissue, measured by qPCR as the ratio of mitochondrial to nuclear genes. Reported as a mean change from baseline.
Measured: Baseline to 6 months and to 12 months
Change in Mitochondrial DNA amount in Subcutaneous Breast Adipose Tissue
Change in Mitochondrial DNA Amount in Subcutaneous Breast Adipose Tissue, measured by qPCR as the ratio of mitochondrial to nuclear genes. Reported as a mean change from baseline.
Measured: Baseline to 6 months and to 12 months
Change in Mitochondrial DNA amount in Subcutaneous Upper Arm Adipose Tissue
Change in Mitochondrial DNA Amount in Subcutaneous Upper Arm Adipose Tissue, measured by qPCR as the ratio of mitochondrial to nuclear genes. Reported as a mean change from baseline.
Measured: Baseline to 6 months and to 12 months
Change in Mitochondrial DNA amount in Subcutaneous Lateral Upper Thigh Adipose Tissue
Change in Mitochondrial DNA Amount in Subcutaneous Lateral Upper Thigh Adipose Tissue, measured by qPCR as the ratio of mitochondrial to nuclear genes. Reported as a mean change from baseline.
Measured: Baseline to 6 months and to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2026
- Study start19 Aug 2014
- Primary completion17 Aug 2016
- Study completion17 Aug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity & OverweightStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Helsinki
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sini Heinonen, University of Helsinki
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07456124
- Sponsor's protocol ID
- HUS71/13/03/01/14
- Acronym
- 4FAT
- Status last verified
- Mar 2026
- First submitted
- 21 Jan 2026
- Last updated
- 6 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data are not publicly shared due to data protection regulations; anonymized data may be available upon reasonable request after study completion.
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adipose Tissue Metabolism in Obesity and Diet-Induced Weight Loss: A Prospective Observational Study of Body Weight, Fat Distribution, and Tissue-Specific Metabolic Adaptations
- ClinicalTrials.gov ID
- NCT07456124
- Acronym / sponsor ID
- 4FAT / HUS71/13/03/01/14
- Conditions
- Obesity & Overweight, Obesity (Disorder)
- Keywords
- Weight loss, obesity, adipose tissue, inflammation, mitochondria, metabolism, conservative treatment of obesity, lifestyle intervention of obesity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- University of HelsinkiUniversity, hospital or other
- Study start
- 19 Aug 2014 (actual)
- Primary completion
- 17 Aug 2016 (actual)
- Study completion
- 17 Aug 2016 (actual)
- First posted
- 6 Mar 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 prospective observational study investigates weight loss and metabolic changes in adults with obesity undergoing standard clinical diet-induced lifestyle treatment and counseling. Participants follow a very-low-calorie diet followed by a conventional weight loss diet in addition to lifestyle counseling and are followed for 12 months. The study examines weight loss as the primary outcome and characterizes changes in body composition, fat distribution, glucose metabolism, inflammation, and adipose tissue biology as secondary outcomes.
Detailed description
Obesity is associated with metabolic complications including insulin resistance, fatty liver disease, dyslipidaemia, and systemic inflammation. Weight loss can improve these complications, yet individuals vary widely in weight loss, fat distribution and metabolic response. Subcutaneous adipose tissue dysfunction, including impaired mitochondrial biogenesis and increased inflammation, is thought to play a central role.
This prospective observational study follows adults with obesity undergoing standard-of-care diet and lifestyle treatment at Helsinki University Central Hospital, Helsinki, Finland. The intervention consists of a very-low-calorie diet for approximately 10 weeks, followed by gradual transition to a conventional weight loss diet and multidisciplinary clinical follow-up.
Assessments are performed at baseline, 6 months, and 12 months and include anthropometry, body composition (BIA, DXA), fasting blood samples, and oral glucose tolerance testing. Subcutaneous adipose tissue biopsies are obtained from four anatomical depots (gluteal, abdominal, breast, and upper arm) for molecular, mitochondrial, epigenetic, and histological analyses.
The primary outcome is diet-induced weight loss over 12 months. Secondary outcomes include changes in fat distribution, insulin sensitivity, lipid profile, inflammation, mitochondrial measures in adipose tissue, and depot-specific adipose tissue characteristics.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diet-Induced Weight Loss Cohort | – | Behavioral: Diet-Induced Weight Loss ProgramAdults with obesity undergoing standard clinical diet treatment including a very-low-calorie diet followed by transition to a conventional weight loss diet and lifestyle counseling |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients seeking treatment for obesity at Helsinki University Central Hospital and affiliated outpatient obesity clinics.
Key inclusion criteria (3 listed)
- Age ≥18 years
- BMI ≥28 kg/m²
- Seeking treatment for obesity at Helsinki University Central Hospital or affiliated units
Key exclusion criteria (5 listed)
- Pregnancy or lactation
- Current smoking
- Anemia (Hb <130 g/L in men; <120 g/L in women)
- Severe comorbid disease or condition judged by investigator to compromise safety
- Contraindications to MRI (e.g., metal implants, claustrophobia)
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 |
|---|---|---|
| Diet-Induced Weight Loss ProgramStandard clinical obesity treatment consisting of a very-low-calorie diet for approximately 10 weeks followed by transition to a conventional weight loss diet with multidisciplinary clinical follow-up. | Behavioural | Diet-Induced Weight Loss Cohort |
Primary outcome
Percent Total Body Weight Loss (%TWL)
Time frame: Baseline to 6 months
Percentage change in body weight from baseline, calculated as 100 × (baseline weight - follow-up weight) / baseline weight
14 secondary outcomes
Change in Body Weight (kg)
Time frame: Baseline to 6 and to 12 months
Change in Total Body Fat Mass (kg)
Time frame: Baseline to 6 months and to 12 months
Change in Body Fat percentage (%)
Time frame: Baseline to 6 and to 12 months
Change in Plasma Glycated Hemoglobin (HbA1c)
Time frame: Baseline to 6 months and to 12 months
Change in HOMA-IR (Homeostatic Model Assessment of Insulin Resistance)
Time frame: Baseline to 6 and to 12 months
Change in Plasma Total Cholesterol (mmol/L)
Time frame: Baseline to 6 months and to 12 months
Change in Plasma LDL Cholesterol (mmol/L)
Time frame: Baseline to 6 months and to 12 months
Change in Plasma HDL Cholesterol (mmol/L)
Time frame: Baseline to 6 months and to 12 months
Change in Plasma Triglycerides (mmol/L)
Time frame: Baseline to 6 months and to 12 months
Change in Plasma C-Reactive Protein Concentration (mg/L)
Time frame: Baseline, to 6 months and to 12 months
Change in Mitochondrial DNA amount in Subcutaneous Abdominal Adipose Tissue
Time frame: Baseline to 6 months and to 12 months
Change in Mitochondrial DNA amount in Subcutaneous Breast Adipose Tissue
Time frame: Baseline to 6 months and to 12 months
Change in Mitochondrial DNA amount in Subcutaneous Upper Arm Adipose Tissue
Time frame: Baseline to 6 months and to 12 months
Change in Mitochondrial DNA amount in Subcutaneous Lateral Upper Thigh Adipose Tissue
Time frame: Baseline to 6 months and to 12 months
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 6 Mar 2026.
- Individual participant dataSharing planned: No. Individual participant data are not publicly shared due to data protection regulations; anonymized data may be available upon reasonable request after study completion.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity & Overweight and Obesity (Disorder), run by University of Helsinki.
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 3 inclusion and 5 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 6 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
Percent Total Body Weight Loss (%TWL) (time frame: Baseline to 6 months). 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 6 Mar 2026.