ObesityNCT01015508
Adipogenic Capacity as a Mediator of Weight Gain
A study testing Very Low Energy Diet (VLED) and Weight maintenance in people with Obesity, run by Maastricht University Medical Center at 1 site in Netherlands.
Trial summary
To demonstrate differences in response of subjects with a high, low or medium predisposition for weight regain after weight reduction in terms of: body composition; energy expenditure; physical activity; and adipogenic capacity. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Very Low Energy Diet (VLED) and Weight maintenance
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteNetherlands
- Study dates
- Feb 2010to Nov 2012
- 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 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- BMI 28-35
- healthy, no medication
- no smoking
- stable weight (no weight loss/gain > 5kg in 3 months prior to study)
Who cannot join
- 28< BMI >35
- use of medication
- smoking
- weight loss/gain > 5kg in 3 months prior to study
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Dept. of Human Biology (Maastricht University)
Maastricht, Limburg, 6229ER
About this study
Official title: The Role of the Genetic Background Involved in Weight Regain Through Mechanisms Including Energy Expenditure, Physical Activity and Adipogenic Capacity
To demonstrate differences in response of subjects with a high, low or medium predisposition for weight regain after weight reduction in terms of: body composition; energy expenditure; physical activity; and adipogenic capacity.
Read the detailed description
The risk for weight regain after weight loss is a major problem for the current obesity treatments, and is largely genetically determined. It is believed that an elucidation of the genetic component in the prognosis of weight management could assist in the development of more effective and individually tailored treatments. However, current research on the genetic component of weight management, and in particular weight regain, is still limited and data available are sometimes inconsistent. The current research proposal aims to identify groups with a high, low or medium predisposition for weight regain, based on a genetic profile and to demonstrate differences in the response of these subjects to a weight maintenance period after weight reduction in terms of body composition, physical activity, adipogenic capacity and energy expenditure.
- Conditions
- Obesity
- Being tested
- Very Low Energy Diet (VLED), Weight maintenance
- Keywords
- Weight loss and maintenance, body composition, energy expenditure, adipogenic capacity, physical activity
- Medical subject headings
- Obesity, Weight Loss, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Very Low Energy Diet (VLED)Other
Also called Modifast
a VLED (Modifast) for 2 months in order to reduce body weight
Weight maintenanceOther
10 months
| Study group | Role | What they receive |
|---|---|---|
| High predisposition | Other | High predisposition for weight regain Receives: Other: Very Low Energy Diet (VLED); Other: Weight maintenance |
| low predisposition | Other | low predisposition for weight regain Receives: Other: Very Low Energy Diet (VLED); Other: Weight maintenance |
| Medium predisposition | Other | Medium predisposition for weight regain Receives: Other: Very Low Energy Diet (VLED); Other: Weight maintenance |
What is being measured
The primary outcome is the main question the study is designed to answer.
Energy expenditure
Measured: 0, 2 and 12 months
Secondary outcomes (1)
Adipogenic capacity, Physical activity and body composition
Measured: 0, 2 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2009 (estimated)
- Study startFeb 2010
- Primary completionNov 2012 (estimated)
- Study completionNov 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Maastricht University Medical CenterThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Klaas R Westerterp, Prof, Principal investigator, Maastricht University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01015508
- Sponsor's protocol ID
- HumBio_Westerterp09
- Status last verified
- Oct 2012
- First submitted
- 17 Nov 2009
- Last updated
- 25 Oct 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Camps SG, Verhoef SP, Roumans N, Bouwman FG, Mariman EC, Westerterp KR. Weight loss-induced changes in adipose tissue proteins associated with fatty acid and glucose metabolism correlate with adaptations in energy expenditure. Nutr Metab (Lond). 2015 Oct 24;12:37. doi: 10.1186/s12986-015-0034-1. eCollection 2015.
PubMed 26500687Camps SG, Verhoef SP, Westerterp KR. Weight loss-induced reduction in physical activity recovers during weight maintenance. Am J Clin Nutr. 2013 Oct;98(4):917-23. doi: 10.3945/ajcn.113.062935. Epub 2013 Aug 28.
PubMed 23985804Verhoef SP, Camps SG, Gonnissen HK, Westerterp KR, Westerterp-Plantenga MS. Concomitant changes in sleep duration and body weight and body composition during weight loss and 3-mo weight maintenance. Am J Clin Nutr. 2013 Jul;98(1):25-31. doi: 10.3945/ajcn.112.054650. Epub 2013 May 22.
PubMed 23697706Camps SG, Verhoef SP, Westerterp KR. Weight loss, weight maintenance, and adaptive thermogenesis. Am J Clin Nutr. 2013 May;97(5):990-4. doi: 10.3945/ajcn.112.050310. Epub 2013 Mar 27.
PubMed 23535105Verhoef SP, Camps SG, Bouwman FG, Mariman EC, Westerterp KR. Physiological response of adipocytes to weight loss and maintenance. PLoS One. 2013;8(3):e58011. doi: 10.1371/journal.pone.0058011. Epub 2013 Mar 7.
PubMed 23505452
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of the Genetic Background Involved in Weight Regain Through Mechanisms Including Energy Expenditure, Physical Activity and Adipogenic Capacity
- ClinicalTrials.gov ID
- NCT01015508
- Acronym / sponsor ID
- HumBio_Westerterp09
- Conditions
- Obesity
- Keywords
- Weight loss and maintenance, body composition, energy expenditure, adipogenic capacity, physical activity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Study start
- Feb 2010
- Primary completion
- Nov 2012 (estimated)
- Study completion
- Nov 2012 (estimated)
- First posted
- 18 Nov 2009 (estimated)
- 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.
To demonstrate differences in response of subjects with a high, low or medium predisposition for weight regain after weight reduction in terms of: body composition; energy expenditure; physical activity; and adipogenic capacity.
Detailed description
The risk for weight regain after weight loss is a major problem for the current obesity treatments, and is largely genetically determined. It is believed that an elucidation of the genetic component in the prognosis of weight management could assist in the development of more effective and individually tailored treatments. However, current research on the genetic component of weight management, and in particular weight regain, is still limited and data available are sometimes inconsistent. The current research proposal aims to identify groups with a high, low or medium predisposition for weight regain, based on a genetic profile and to demonstrate differences in the response of these subjects to a weight maintenance period after weight reduction in terms of body composition, physical activity, adipogenic capacity and energy expenditure.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| High predisposition | Other | Other: Very Low Energy Diet (VLED), Other: Weight maintenanceHigh predisposition for weight regain |
| low predisposition | Other | Other: Very Low Energy Diet (VLED), Other: Weight maintenancelow predisposition for weight regain |
| Medium predisposition | Other | Other: Very Low Energy Diet (VLED), Other: Weight maintenanceMedium predisposition for weight regain |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- BMI 28-35
- healthy, no medication
- no smoking
- stable weight (no weight loss/gain > 5kg in 3 months prior to study)
Key exclusion criteria (4 listed)
- 28< BMI >35
- use of medication
- smoking
- weight loss/gain > 5kg in 3 months prior to 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 |
|---|---|---|
| Very Low Energy Diet (VLED)Also: Modifasta VLED (Modifast) for 2 months in order to reduce body weight | Other | High predisposition, Medium predisposition, low predisposition |
| Weight maintenance10 months | Other | High predisposition, Medium predisposition, low predisposition |
Primary outcome
Energy expenditure
Time frame: 0, 2 and 12 months
1 secondary outcome
Adipogenic capacity, Physical activity and body composition
Time frame: 0, 2 and 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2012.
- Derived from this study: PubMed 26500687Camps SG, Verhoef SP, Roumans N, Bouwman FG, Mariman EC, Westerterp KR. Weight loss-induced changes in adipose tissue proteins associated with fatty acid and glucose metabolism correlate with adaptations in energy expenditure. Nutr Metab (Lond). 2015 Oct 24;12:37. doi: 10.1186/s12986-015-0034-1. eCollection 2015.
- Derived from this study: PubMed 23985804Camps SG, Verhoef SP, Westerterp KR. Weight loss-induced reduction in physical activity recovers during weight maintenance. Am J Clin Nutr. 2013 Oct;98(4):917-23. doi: 10.3945/ajcn.113.062935. Epub 2013 Aug 28.
- Derived from this study: PubMed 23697706Verhoef SP, Camps SG, Gonnissen HK, Westerterp KR, Westerterp-Plantenga MS. Concomitant changes in sleep duration and body weight and body composition during weight loss and 3-mo weight maintenance. Am J Clin Nutr. 2013 Jul;98(1):25-31. doi: 10.3945/ajcn.112.054650. Epub 2013 May 22.
- Derived from this study: PubMed 23535105Camps SG, Verhoef SP, Westerterp KR. Weight loss, weight maintenance, and adaptive thermogenesis. Am J Clin Nutr. 2013 May;97(5):990-4. doi: 10.3945/ajcn.112.050310. Epub 2013 Mar 27.
- Derived from this study: PubMed 23505452Verhoef SP, Camps SG, Bouwman FG, Mariman EC, Westerterp KR. Physiological response of adipocytes to weight loss and maintenance. PLoS One. 2013;8(3):e58011. doi: 10.1371/journal.pone.0058011. Epub 2013 Mar 7.
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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.
Klaas R Westerterp, Prof principal investigator
Maastricht University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Very Low Energy Diet (VLED) and Weight maintenance in people with Obesity, run by Maastricht University Medical Center at 1 site in Netherlands.
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 4 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: status not confirmed, as of the sponsor's last update on 25 Oct 2012. 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 Netherlands. 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?
Results are not available in the source record.
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?
Energy expenditure (time frame: 0, 2 and 12 months). 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 NCT01015508, which also lists 5 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 25 Oct 2012; AzTrials last refreshed its copy on 7 Nov 2026.