ObesityPROBNCT07355933
Metabolic Flexibility and Metabolic Heath in Human Obesity
A study testing Body Weight Loss in people with Obesity, run by Jose Galgani at 1 site in Chile.
Trial summary
This interventional study explores the relationship between improvements in metabolic health following weight loss and changes in whole-body fat mass and its distribution. The study focuses on adult men and women with excess body weight undergoing dietary energy restriction over 12 weeks. Read more about this study
- Who is it for?
- Ages 30 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Body Weight Loss
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteChile
- Study dates
- 23 Sep 2022to 6 Jan 2025
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- males or females
- 30-55 y old
- physically inactive (<600 MET´min/wk of self-reported moderate-vigorous physical activity
- stable body weight for at least the past 6 months (±2 kg)
- healthy according to medical history and routine hematology and biochemistry.
Who cannot join
- Individuals with physiological (pregnancy, lactation) or pathological (under drug therapy for and/or having cardiovascular, liver, kidney, thyroid diseases)
- conditions affecting energy metabolism or eating behavior
- Subjects having low-fat (<20% energy) or low-carbohydrate (<45% energy) diets
- Smokers and alcohol abusers
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Metabolic Flexibility, Eating Behavior and Adipose Tissue Expandability: Role of This Triad in the Propensity to Human Obesity
This interventional study explores the relationship between improvements in metabolic health following weight loss and changes in whole-body fat mass and its distribution. The study focuses on adult men and women with excess body weight undergoing dietary energy restriction over 12 weeks. The primary research question is: Does a greater reduction in fat mass for a given weight loss correlate with more significant improvements in metabolic health?
Read the detailed description
Obesity is a well-established risk factor for disruptions in metabolic health, which often precede cardiovascular disease and type-2 diabetes. While the precise pathophysiological mechanisms linking obesity to these conditions remain unclear, it is widely acknowledged that an increase in fat mass plays a central role, including the expansion of adipose tissue and the accumulation of lipids in non-adipose tissues. As a result, a primary approach to improving metabolic health is to reduce fat mass through negative energy balance. However, lifestyle changes or pharmacological interventions aimed at inducing a negative energy balance do not exclusively target fat mass and often result in the loss of fat-free mass to varying degrees. Given that higher fat mass, rather than fat-free mass, is more strongly associated with impaired metabolic health, strategies that maximize fat mass loss while preserving fat-free mass may offer more significant benefits for metabolic health. Surprisingly, there is a lack of evidence to support this hypothesis. To address this gap, it will be evaluated the relationship between changes in metabolic health and body composition, independent of overall weight loss, in individuals with overweight or obesity undergoing dietary energy restriction. It is hypothesized that greater fat mass reduction will be linked to more substantial improvements in metabolic health for a given weight loss.
- Conditions
- Obesity
- Being tested
- Body Weight Loss
- Keywords
- OBESITY, WEIGHT LOSS, EATING BEHAVIOR, METABOLIC FLEXIBILITY, BODY COMPOSITION
- Medical subject headings
- Obesity, Weight Loss, Feeding Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Body Weight LossOther
Individuals will be prescribed a hypocaloric diet (1300 kcal/d). Individuals will receive a booklet detailing the type of meals and foods to be consumed in each mealtime. A dietitian will explain how to enhance dietary compliance. Every two weeks, body weight, vital signs, and adverse events will be monitored. In addition, food recalls will be conducted in order to optimize dietary energy restriction compliance. During weight maintenance, energy intake will be adjusted to energy requirements to maintain weight stability (±2.5 kg) for at least 3 weeks. During weight loss and maintenance, participants will be instructed to maintain their customary physical activity.
| Study group | Role | What they receive |
|---|---|---|
| Weight Loss Intervention | Other | Individuals with overweight or obesity will undergo dietary energy restriction aimed to induce 8 to 12% weight loss after 12 weeks. For 3 to 5 weeks, body weight will be maintained. Receives: Other: Body Weight Loss |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fasting serum triglyceride concentration
In overnight fasted individuals, a blood sample will be drawn. Serum will be isolated and stored at -80C until assessment.
Measured: From enrollment to the end of weight maintenance period at 15-20 weeks
Secondary outcomes (1)
HOMA-IR
In overnight fasted individuals, a blood sample will be drawn for glucose and insulin assessment. HOMA-IR will be calculated using this formula: (glucose, mM * insulin, uU/mL)/22.5. Serum/Plasma will be isolated and stored at -80C until assessment.
Measured: From enrollment to the end of weight maintenance period at 15-20 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2026
- Study start23 Sep 2022
- Primary completion6 Jan 2025
- Study completion6 Jan 2025
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jose Galgani
- Sponsor type
- University, hospital or other
- Collaborators
- Agencia Nacional de Investigación y Desarrollo
- Responsible party
- Sponsor-investigator, Jose Galgani, Pontificia Universidad Catolica de Chile
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07355933
- Sponsor's protocol ID
- 200602001
- Acronym
- PROB
- Status last verified
- Feb 2026
- First submitted
- 25 Jul 2025
- Last updated
- 27 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metabolic Flexibility, Eating Behavior and Adipose Tissue Expandability: Role of This Triad in the Propensity to Human Obesity
- ClinicalTrials.gov ID
- NCT07355933
- Acronym / sponsor ID
- PROB / 200602001
- Conditions
- Obesity
- Keywords
- OBESITY, WEIGHT LOSS, EATING BEHAVIOR, METABOLIC FLEXIBILITY, BODY COMPOSITION
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Jose GalganiUniversity, hospital or other
- Collaborators
- Agencia Nacional de Investigación y Desarrollo
- Study start
- 23 Sep 2022 (actual)
- Primary completion
- 6 Jan 2025 (actual)
- Study completion
- 6 Jan 2025 (actual)
- First posted
- 21 Jan 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 explores the relationship between improvements in metabolic health following weight loss and changes in whole-body fat mass and its distribution. The study focuses on adult men and women with excess body weight undergoing dietary energy restriction over 12 weeks. The primary research question is: Does a greater reduction in fat mass for a given weight loss correlate with more significant improvements in metabolic health?
Detailed description
Obesity is a well-established risk factor for disruptions in metabolic health, which often precede cardiovascular disease and type-2 diabetes. While the precise pathophysiological mechanisms linking obesity to these conditions remain unclear, it is widely acknowledged that an increase in fat mass plays a central role, including the expansion of adipose tissue and the accumulation of lipids in non-adipose tissues. As a result, a primary approach to improving metabolic health is to reduce fat mass through negative energy balance. However, lifestyle changes or pharmacological interventions aimed at inducing a negative energy balance do not exclusively target fat mass and often result in the loss of fat-free mass to varying degrees. Given that higher fat mass, rather than fat-free mass, is more strongly associated with impaired metabolic health, strategies that maximize fat mass loss while preserving fat-free mass may offer more significant benefits for metabolic health. Surprisingly, there is a lack of evidence to support this hypothesis. To address this gap, it will be evaluated the relationship between changes in metabolic health and body composition, independent of overall weight loss, in individuals with overweight or obesity undergoing dietary energy restriction. It is hypothesized that greater fat mass reduction will be linked to more substantial improvements in metabolic health for a given weight loss.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Weight Loss Intervention | Other | Other: Body Weight LossIndividuals with overweight or obesity will undergo dietary energy restriction aimed to induce 8 to 12% weight loss after 12 weeks. For 3 to 5 weeks, body weight will be maintained. |
Who may qualify
- Ages
- 30 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- males or females
- 30-55 y old
- physically inactive (<600 MET´min/wk of self-reported moderate-vigorous physical activity
- stable body weight for at least the past 6 months (±2 kg)
- healthy according to medical history and routine hematology and biochemistry.
Key exclusion criteria (4 listed)
- Individuals with physiological (pregnancy, lactation) or pathological (under drug therapy for and/or having cardiovascular, liver, kidney, thyroid diseases)
- conditions affecting energy metabolism or eating behavior
- Subjects having low-fat (<20% energy) or low-carbohydrate (<45% energy) diets
- Smokers and alcohol abusers
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 |
|---|---|---|
| Body Weight LossIndividuals will be prescribed a hypocaloric diet (1300 kcal/d). Individuals will receive a booklet detailing the type of meals and foods to be consumed in each mealtime. A dietitian will explain how to enhance dietary compliance. Every two weeks, body weight, vital signs, and adverse events will be monitored. In addition, food recalls will be conducted in order to optimize dietary energy restriction compliance. During weight maintenance, energy intake will be adjusted to energy requirements to maintain weight stability (±2.5 kg) for at least 3 weeks. During weight loss and maintenance, participants will be instructed to maintain their customary physical activity. | Other | Weight Loss Intervention |
Primary outcome
Fasting serum triglyceride concentration
Time frame: From enrollment to the end of weight maintenance period at 15-20 weeks
In overnight fasted individuals, a blood sample will be drawn. Serum will be isolated and stored at -80C until assessment.
1 secondary outcome
HOMA-IR
Time frame: From enrollment to the end of weight maintenance period at 15-20 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 27 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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 Body Weight Loss in people with Obesity, run by Jose Galgani at 1 site in Chile.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 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 27 Feb 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 Chile. 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?
Fasting serum triglyceride concentration (time frame: From enrollment to the end of weight maintenance period at 15-20 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 27 Feb 2026.