ObesityLIONNCT04023942
Personalized Nutrition and eHealth: Lifestyle Intervention (LION) Study for Weight Loss Maintenance
A study testing Weight maintenance intervention in people with Obesity, run by Technical University of Munich at 1 site in Germany.
Trial summary
Despite standardized intervention strategies, weight loss and weight loss maintenance largely differ from person to person. Factors which may contribute to these individual differences is current object of research. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Obesity
- What is being tested?
- Weight maintenance intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 272 participants
- Where
- 1 siteGermany
- Study dates
- 17 Jul 2019to 29 Feb 2024
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age: 18 - 65 years
- BMI: 30,0 - 39,9 kg/m2
- Owner of a smartphone
- Caucasian
- No severe diseases
- Informed written consent
Who cannot join
- Diabetes mellitus
- Severe cardiovascular and/or respiratory disease
- Untreated high blood pressure
- Severe kidney disease
- Active cancer (or in remission)
- Inflammatory bowel disease
Show all 18Show fewer
- Severe chronic infections and/or inflammations
- Severe mental-health disorders
- Neurodegenerative disorders
- Endocrine diseases
- Lipedema
- Pregnancy and lactation
- Vigorous weight fluctuations (> 5 kg) in the last 3 months
- Immobility
- Surgery in the last 3 months
- Participation in other intervention studies
- Carrier of pace makers
- Blood donation or transfusion in the last 3 months
Trial locations and contacts
1 site in 1 country.
Germany1 site
Institute for Nutritional Medicine, Technical University of Munich
Munich, Bavaria, 80992
About this study
Official title: Lifestyle Intervention Study
Despite standardized intervention strategies, weight loss and weight loss maintenance largely differ from person to person. Factors which may contribute to these individual differences is current object of research.
In order to investigate predictors and barriers for weight management and to investigate two different dietary interventions and two different digital tools for weight maintenance, the LION-Study was designed as follows: Step I (screening, baseline phenotyping), step II (weight loss intervention with formula diet), step III (weight maintenance intervention with 4 intervention groups: low carb/newsletter; low carb/app; low fat/newsletter; low fat/app) and step IV (follow-up). Participants are required to attend visits at seven time points.
Read more
At screening (month 0) a telephone-based screening interview takes place, in order to test eligibility of the potential participant. If the person is eligible, two consecutive baseline face-to-face visits are planned during step I. After completion of the eight weeks weight loss intervention (month 3), an additional visit takes place followed by three consecutive visits in the weight maintenance step (month 6, 9 and 15). The study ends with a final visit after the follow-up (month 27). Additional contacts (face-to-face and telephone) take place during the weight loss intervention step. Participants will regularly receive a bag with the required formula diet meals. During these "pick up" appointments, the study team actively get in face-to-face contact with participants.
At the different visits, data are collected by questionnaires, medical investigations (e.g. MRI, motor function, resting metabolic rate), blood withdrawal as well as urine, feces and saliva sampling.
Primary objective is to evaluate the effect of two diets (low carb/low fat) and two digital tools (app/newsletter) on long-term weight loss maintenance 12 months after weight loss.
Secondary objective is to identify genetic, epigenetic, physiological, psychological and lifestyle factors that predict the success of weight loss and weight loss maintenance.
Read the detailed description
Step I - Screening and baseline phenotyping When a potential suitable participant is interested, a screening interview to check eligibility will take place by phone after oral agreement is given. The structured screening interview is carried out by means of a questionnaire in the format of a Case Report Form (CRF). Suitable persons are provided with participant´s information and data protection sheet and with the "declaration of consent". Sufficient time for consideration is given between the screening interview and visit 1A, where written consent is signed.
After the telephone-based screening interview, eligible participants are required to provide written consent. Participants will undergo clinical examinations at two visits (V1A + V1B), serving primarily for phenotyping as well as for detection of potentially unknown exclusion criteria. The order of some measurements carried out during V1A and V1B as well as the type of lipid challenge is randomized.
Data collection V1A:
- Resting metabolic rate
- Metabolic response to meal challenge
- Anthropometry
- Vital parameters
- Blood parameters
- Clinical, lifestyle (nutrition, physical activity), psychological, environmental and social factors (questionnaires and protocols)
- Sampling of blood samples for further research questions
Data collection V1B:
- Metabolic response to meal challenge
- Vital parameters
- Blood parameters
- Urine parameters
- Hand Strength Measurement
- Clinical, lifestyle (nutrition, physical activity), psychological, environmental and social factors (questionnaires and protocols)
- Sampling of blood, urine and saliva
- Optional: Adipose tissue distribution by MRI measurement; parameters for physical strength, motor function and body static condition; 24h urine collection; fecal samples
Step II - Weight loss intervention Once participant is still deemed eligible after V1A and V1B, the formula-based low calorie diet (LCD) starts as weight loss intervention. Formula products will be provided once per week. An additional daily intake of 200 g raw or cooked non-starchy vegetables is allowed. Participants fulfill a food diary to record eaten products including drinks and vegetables and to record well-being or side effects. Furthermore, participants are phenotyped by a continuous glucose measurement during the first four weeks of intervention.
Data collection V2:
- Anthropometry
- Vital parameters
- Blood and urine parameters
- Clinical, lifestyle (nutrition, physical activity), psychological, environmental and social factors (questionnaires and protocols)
- Resting metabolic rate
- Hand strength measurement
- Documentation of safety
- Continuous glucose measurement
- Sampling of blood, urine, and saliva
- Optional: Adipose tissue distribution by MRI measurement; parameters for physical strength, motor function and body static condition; 24h urine collection; fecal samples Step III - Weight maintenance intervention
If weight loss is > 4 kg after eight weeks, the participant is eligible for randomization into one of the following four weight maintenance intervention arms:
Low carb - App-based group Low carb - Newsletter-based group Low fat - App-based group Low fat - Newsletter-based group
Data collection V3A:
- Anthropometry
- Blood and urine parameters
- Clinical, lifestyle (nutrition, physical activity), psychological, environmental and social factors (questionnaires and protocols)
- Documentation of safety
- Sampling of blood and urine samples for further research questions, e.g. metabolic profile (to be confirmed)
- Optional: 24h urine collection
Data collection V3B:
- Anthropometry
- Blood parameters
- Clinical, lifestyle (nutrition, physical activity), psychological, environmental and social factors (questionnaires and protocols)
- Documentation of safety
- Sampling of blood samples for further research questions, e.g. metabolic profile (to be confirmed)
Data collection V3C:
- Anthropometry
- Blood and urine parameters
- Resting metabolic rate
- Vital parameters
- Clinical, lifestyle (nutrition, physical activity), psychological, environmental and social factors (questionnaires and protocols)
- Documentation of safety
- Hand strength measurement
- Sampling of blood, urine, and saliva
- Optional: Adipose tissue distribution by MRI measurement; parameters for physical strength, motor function and body static condition; 24h urine collection; fecal samples Step IV - Follow-up During follow-up, all participants receive the same newsletters with nutritional information every 3 months (independent of weight maintenance intervention group). Further weight management is carried out by "self-help".
Data collection V4:
- Anthropometry
- Vital parameters
- Blood parameters (
- Clinical, lifestyle (nutrition, physical activity), psychological, environmental and social factors (questionnaires and protocols)
- Resting metabolic rate
- Sampling of blood
- Conditions
- Obesity
- Being tested
- Weight maintenance intervention
- Keywords
- Obesity, Weight loss, Weight maintenance, Lifestyle intervention, Dietary intervention, Formula diet, App, Newsletter, Digital tool, Low carb, Low fat, Meal challenges
- Medical subject headings
- Obesity, Weight Loss, Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Weight maintenance interventionBehavioural
Also called Dietary Intervention
Weight maintenance intervention (52 weeks): After randomization, participants will follow either a low carb or a low fat diet and get nutritional assistance either by an app or a newsletter, based on the group they got randomized to (low carb/app, low carb/newsletter, low fat/app, low fat/newsletter).
| Study group | Role | What they receive |
|---|---|---|
| Low carb - App-based group | Active comparator | Low carb is defined as 30 energy percent from carbs and consist of 20 energy percent from protein. The daily energy requirement is calculated for each participant individually, based on his/hers resting metabolic rate and physical activity level. Daily energy intake should be 10% lower than the calculated daily energy requirement. Participants assigned to the app-based group works together with a personal coach via app, providing nutritional guidance and support during the 12-month weight maintenance step. Receives: Behavioral: Weight maintenance intervention |
| Low carb - Newsletter-based group | Active comparator | Low carb is defined as 30 energy percent from carbs and consist of 20 energy percent from protein. The daily energy requirement is calculated for each participant individually, based on his/hers resting metabolic rate and physical activity level. Daily energy intake should be 10% lower than the calculated daily energy requirement. The newsletter intervention group gets regularly digital newsletters, in the same frequency as "contacts" take place in the app-based group. Receives: Behavioral: Weight maintenance intervention |
| Low fat - App-based group | Active comparator | Low fat is defined as 25 energy percent from fat and consist of 20 energy percent from protein. The daily energy requirement is calculated for each participant individually, based on his/hers resting metabolic rate and physical activity level. Daily energy intake should be 10% lower than the calculated daily energy requirement. Participants assigned to the app-based group works together with a personal coach via app, providing nutritional guidance and support during the 12-month weight maintenance step. Receives: Behavioral: Weight maintenance intervention |
| Low fat - Newsletter-based group | Active comparator | Low fat is defined as 25 energy percent from fat and consist of 20 energy percent from protein. The daily energy requirement is calculated for each participant individually, based on his/hers resting metabolic rate and physical activity level. Daily energy intake should be 10% lower than the calculated daily energy requirement. The newsletter intervention group gets regularly digital newsletters, in the same frequency as "contacts" take place in the app-based group. Receives: Behavioral: Weight maintenance intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight maintenance 12 months after weight loss intervention
Body weight change in kg and % (from baseline weight)
Measured: 15 months
Secondary outcomes (10)
Weight change after eight weeks of formula diet
Body weight in kg and % (from baseline weight)
Measured: month 3
Glucose
Change in glucose in mg/dl
Measured: month 0, 3, 6, 9, 12, 15, 27
Insulin
Change in insulin in µU/ml
Measured: month 0, 3, 6, 9, 12, 15, 27
Lipids
Change in blood lipids (total cholesterin, triglyzeride, HDL cholesterin, LDL cholesterin - highly correlated to each other) in mg/dl
Measured: month 0, 3, 6, 9, 12, 15, 27
Leptin
Change in leptin in ng/ml
Measured: month 0, 3, 6, 9, 12, 15, 27
Resting metabolic rate
Resting metabolic rate in kilocalories / 24 hours
Measured: month 0, 3, 15, 27
Magnetic resonance imaging (MRI)
MRI data (organ volume, proton density fat fraction)
Measured: month 0, 3, 15, 27
Insulin response on meal challenges
Insulin response at different time points during meal challenge in µU/ml
Measured: month 0
Glucose response on meal challenges
Glucose response at different time points during meal challenge in mg/dl
Measured: month 0
Lipid response on meal challenges
Lipid (total cholesterin, triglyzeride, HDL cholesterin, LDL cholesterin - highly correlated to each other) response at different time points during meal challenge in mg/dl
Measured: month 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2019
- Study start17 Jul 2019
- Primary completion19 Jan 2023
- Study completion29 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Technical University of MunichThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This clinical study is a single-center 2\*2 factorial randomized trial. For the weight maintenance step, participants will be randomized into one of the four weight maintenance intervention arms.
- Masking
- None (open label)
- Enrolment
- 272 participants (actual)
Sponsor and investigators
- Lead sponsor
- Technical University of Munich
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christina Holzapfel, Technical University of Munich
- Investigators
- Christina Holzapfel, PhD, Principal investigator, TUM School of Medicine, Technical University of Munich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04023942
- Sponsor's protocol ID
- 01EA1709
- Acronym
- LION
- Status last verified
- Aug 2024
- First submitted
- 11 Jul 2019
- Last updated
- 4 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We will apply principles which meet standards of findability, accessibility, interoperability, and reusability (FAIR) in the management of data in our project. The owner of the data will be the Institute for Nutritional Medicine at TUM School of Medicine, Technical University of Munich. The data and samples will be safely stored for long term and can be easily accessed and/or downloaded by the study team. For collaboration partners defined dataset and samples will be provided with well-defined license and access conditions.
Publications
Reik A, Schauberger G, Wiechert M, Hauner H, Holzapfel C. Association Between the Postprandial Response to an Oral Glucose Tolerance Test and Anthropometric Changes After an 8-Week Low-Calorie Formula Diet - Results From the Lifestyle Intervention (LION) Study. Mol Nutr Food Res. 2024 Jun;68(12):e2400106. doi: 10.1002/mnfr.202400106. Epub 2024 Jun 8.
PubMed 38850172Reik A, Holzapfel C. Randomized Controlled Lifestyle Intervention (LION) Study for Weight Loss and Maintenance in Adults With Obesity-Design and Methods. Front Nutr. 2020 Nov 10;7:586985. doi: 10.3389/fnut.2020.586985. eCollection 2020.
PubMed 33240920Junker D, Wu M, Reik A, Raspe J, Rupp S, Han J, Nabauer SM, Wiechert M, Somasundaram A, Burian E, Waschulzik B, Makowski MR, Hauner H, Holzapfel C, Karampinos DC. Impact of baseline adipose tissue characteristics on change in adipose tissue volume during a low calorie diet in people with obesity-results from the LION study. Int J Obes (Lond). 2024 Sep;48(9):1332-1341. doi: 10.1038/s41366-024-01568-6. Epub 2024 Jun 26.
PubMed 38926461Somasundaram A, Wu M, Reik A, Rupp S, Han J, Naebauer S, Junker D, Patzelt L, Wiechert M, Zhao Y, Rueckert D, Hauner H, Holzapfel C, Karampinos DC. Evaluating Sex-specific Differences in Abdominal Fat Volume and Proton Density Fat Fraction at MRI Using Automated nnU-Net-based Segmentation. Radiol Artif Intell. 2024 Jul;6(4):e230471. doi: 10.1148/ryai.230471.
PubMed 38809148
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lifestyle Intervention Study
- ClinicalTrials.gov ID
- NCT04023942
- Acronym / sponsor ID
- LION / 01EA1709
- Conditions
- Obesity
- Keywords
- Obesity, Weight loss, Weight maintenance, Lifestyle intervention, Dietary intervention, Formula diet, App, Newsletter
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 272 participants (actual)
- Lead sponsor
- Technical University of MunichUniversity, hospital or other
- Study start
- 17 Jul 2019 (actual)
- Primary completion
- 19 Jan 2023 (actual)
- Study completion
- 29 Feb 2024 (actual)
- First posted
- 18 Jul 2019 (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.
Despite standardized intervention strategies, weight loss and weight loss maintenance largely differ from person to person. Factors which may contribute to these individual differences is current object of research.
In order to investigate predictors and barriers for weight management and to investigate two different dietary interventions and two different digital tools for weight maintenance, the LION-Study was designed as follows: Step I (screening, baseline phenotyping), step II (weight loss intervention with formula diet), step III (weight maintenance intervention with 4 intervention groups: low carb/newsletter; low carb/app; low fat/newsletter; low fat/app) and step IV (follow-up). Participants are required to attend visits at seven time points.
At screening (month 0) a telephone-based screening interview takes place, in order to test eligibility of the potential participant. If the person is eligible, two consecutive baseline face-to-face visits are planned during step I. After completion of the eight weeks weight loss intervention (month 3), an additional visit takes place followed by three consecutive visits in the weight maintenance step (month 6, 9 and 15). The study ends with a final visit after the follow-up (month 27). Additional contacts (face-to-face and telephone) take place during the weight loss intervention step. Participants will regularly receive a bag with the required formula diet meals. During these "pick up" appointments, the study team actively get in face-to-face contact with participants.
At the different visits, data are collected by questionnaires, medical investigations (e.g. MRI, motor function, resting metabolic rate), blood withdrawal as well as urine, feces and saliva sampling.
Primary objective is to evaluate the effect of two diets (low carb/low fat) and two digital tools (app/newsletter) on long-term weight loss maintenance 12 months after weight loss.
Secondary objective is to identify genetic, epigenetic, physiological, psychological and lifestyle factors that predict the success of weight loss and weight loss maintenance.
Detailed description
Step I - Screening and baseline phenotyping When a potential suitable participant is interested, a screening interview to check eligibility will take place by phone after oral agreement is given. The structured screening interview is carried out by means of a questionnaire in the format of a Case Report Form (CRF). Suitable persons are provided with participant´s information and data protection sheet and with the "declaration of consent". Sufficient time for consideration is given between the screening interview and visit 1A, where written consent is signed.
After the telephone-based screening interview, eligible participants are required to provide written consent. Participants will undergo clinical examinations at two visits (V1A + V1B), serving primarily for phenotyping as well as for detection of potentially unknown exclusion criteria. The order of some measurements carried out during V1A and V1B as well as the type of lipid challenge is randomized.
Data collection V1A:
- Resting metabolic rate
- Metabolic response to meal challenge
- Anthropometry
- Vital parameters
- Blood parameters
- Clinical, lifestyle (nutrition, physical activity), psychological, environmental and social factors (questionnaires and protocols)
- Sampling of blood samples for further research questions
Data collection V1B:
- Metabolic response to meal challenge
- Vital parameters
- Blood parameters
- Urine parameters
- Hand Strength Measurement
- Clinical, lifestyle (nutrition, physical activity), psychological, environmental and social factors (questionnaires and protocols)
- Sampling of blood, urine and saliva
- Optional: Adipose tissue distribution by MRI measurement; parameters for physical strength, motor function and body static condition; 24h urine collection; fecal samples
Step II - Weight loss intervention Once participant is still deemed eligible after V1A and V1B, the formula-based low calorie diet (LCD) starts as weight loss intervention. Formula products will be provided once per week. An additional daily intake of 200 g raw or cooked non-starchy vegetables is allowed. Participants fulfill a food diary to record eaten products including drinks and vegetables and to record well-being or side effects. Furthermore, participants are phenotyped by a continuous glucose measurement during the first four weeks of intervention.
Data collection V2:
- Anthropometry
- Vital parameters
- Blood and urine parameters
- Clinical, lifestyle (nutrition, physical activity), psychological, environmental and social factors (questionnaires and protocols)
- Resting metabolic rate
- Hand strength measurement
- Documentation of safety
- Continuous glucose measurement
- Sampling of blood, urine, and saliva
- Optional: Adipose tissue distribution by MRI measurement; parameters for physical strength, motor function and body static condition; 24h urine collection; fecal samples Step III - Weight maintenance intervention
If weight loss is > 4 kg after eight weeks, the participant is eligible for randomization into one of the following four weight maintenance intervention arms:
Low carb - App-based group Low carb - Newsletter-based group Low fat - App-based group Low fat - Newsletter-based group
Data collection V3A:
- Anthropometry
- Blood and urine parameters
- Clinical, lifestyle (nutrition, physical activity), psychological, environmental and social factors (questionnaires and protocols)
- Documentation of safety
- Sampling of blood and urine samples for further research questions, e.g. metabolic profile (to be confirmed)
- Optional: 24h urine collection
Data collection V3B:
- Anthropometry
- Blood parameters
- Clinical, lifestyle (nutrition, physical activity), psychological, environmental and social factors (questionnaires and protocols)
- Documentation of safety
- Sampling of blood samples for further research questions, e.g. metabolic profile (to be confirmed)
Data collection V3C:
- Anthropometry
- Blood and urine parameters
- Resting metabolic rate
- Vital parameters
- Clinical, lifestyle (nutrition, physical activity), psychological, environmental and social factors (questionnaires and protocols)
- Documentation of safety
- Hand strength measurement
- Sampling of blood, urine, and saliva
- Optional: Adipose tissue distribution by MRI measurement; parameters for physical strength, motor function and body static condition; 24h urine collection; fecal samples Step IV - Follow-up During follow-up, all participants receive the same newsletters with nutritional information every 3 months (independent of weight maintenance intervention group). Further weight management is carried out by "self-help".
Data collection V4:
- Anthropometry
- Vital parameters
- Blood parameters (
- Clinical, lifestyle (nutrition, physical activity), psychological, environmental and social factors (questionnaires and protocols)
- Resting metabolic rate
- Sampling of blood
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- This clinical study is a single-center 2*2 factorial randomized trial. For the weight maintenance step, participants will be randomized into one of the four weight maintenance intervention arms.
| Arm | Type | Receives |
|---|---|---|
| Low carb - App-based group | Active comparator | Behavioral: Weight maintenance interventionLow carb is defined as 30 energy percent from carbs and consist of 20 energy percent from protein. The daily energy requirement is calculated for each participant individually, based on his/hers resting metabolic rate and physical activity level. Daily energy intake should be 10% lower than the calculated daily energy requirement. Participants assigned to the app-based group works together with a personal coach via app, providing nutritional guidance and support during the 12-month weight maintenance step. |
| Low carb - Newsletter-based group | Active comparator | Behavioral: Weight maintenance interventionLow carb is defined as 30 energy percent from carbs and consist of 20 energy percent from protein. The daily energy requirement is calculated for each participant individually, based on his/hers resting metabolic rate and physical activity level. Daily energy intake should be 10% lower than the calculated daily energy requirement. The newsletter intervention group gets regularly digital newsletters, in the same frequency as "contacts" take place in the app-based group. |
| Low fat - App-based group | Active comparator | Behavioral: Weight maintenance interventionLow fat is defined as 25 energy percent from fat and consist of 20 energy percent from protein. The daily energy requirement is calculated for each participant individually, based on his/hers resting metabolic rate and physical activity level. Daily energy intake should be 10% lower than the calculated daily energy requirement. Participants assigned to the app-based group works together with a personal coach via app, providing nutritional guidance and support during the 12-month weight maintenance step. |
| Low fat - Newsletter-based group | Active comparator | Behavioral: Weight maintenance interventionLow fat is defined as 25 energy percent from fat and consist of 20 energy percent from protein. The daily energy requirement is calculated for each participant individually, based on his/hers resting metabolic rate and physical activity level. Daily energy intake should be 10% lower than the calculated daily energy requirement. The newsletter intervention group gets regularly digital newsletters, in the same frequency as "contacts" take place in the app-based group. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age: 18 - 65 years
- BMI: 30,0 - 39,9 kg/m2
- Owner of a smartphone
- Caucasian
- No severe diseases
Key exclusion criteria (18 listed)
- Diabetes mellitus
- Severe cardiovascular and/or respiratory disease
- Untreated high blood pressure
- Severe kidney disease
- Active cancer (or in remission)
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 |
|---|---|---|
| Weight maintenance interventionAlso: Dietary InterventionWeight maintenance intervention (52 weeks): After randomization, participants will follow either a low carb or a low fat diet and get nutritional assistance either by an app or a newsletter, based on the group they got randomized to (low carb/app, low carb/newsletter, low fat/app, low fat/newsletter). | Behavioural | Low carb - App-based group, Low carb - Newsletter-based group, Low fat - App-based group, Low fat - Newsletter-based group |
Primary outcome
Weight maintenance 12 months after weight loss intervention
Time frame: 15 months
Body weight change in kg and % (from baseline weight)
10 secondary outcomes
Weight change after eight weeks of formula diet
Time frame: month 3
Glucose
Time frame: month 0, 3, 6, 9, 12, 15, 27
Insulin
Time frame: month 0, 3, 6, 9, 12, 15, 27
Lipids
Time frame: month 0, 3, 6, 9, 12, 15, 27
Leptin
Time frame: month 0, 3, 6, 9, 12, 15, 27
Resting metabolic rate
Time frame: month 0, 3, 15, 27
Magnetic resonance imaging (MRI)
Time frame: month 0, 3, 15, 27
Insulin response on meal challenges
Time frame: month 0
Glucose response on meal challenges
Time frame: month 0
Lipid response on meal challenges
Time frame: month 0
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 4 Dec 2024.
- Results publication: PubMed 38850172Reik A, Schauberger G, Wiechert M, Hauner H, Holzapfel C. Association Between the Postprandial Response to an Oral Glucose Tolerance Test and Anthropometric Changes After an 8-Week Low-Calorie Formula Diet - Results From the Lifestyle Intervention (LION) Study. Mol Nutr Food Res. 2024 Jun;68(12):e2400106. doi: 10.1002/mnfr.202400106. Epub 2024 Jun 8.
- Results publication: PubMed 33240920Reik A, Holzapfel C. Randomized Controlled Lifestyle Intervention (LION) Study for Weight Loss and Maintenance in Adults With Obesity-Design and Methods. Front Nutr. 2020 Nov 10;7:586985. doi: 10.3389/fnut.2020.586985. eCollection 2020.
- Results publication: PubMed 38926461Junker D, Wu M, Reik A, Raspe J, Rupp S, Han J, Nabauer SM, Wiechert M, Somasundaram A, Burian E, Waschulzik B, Makowski MR, Hauner H, Holzapfel C, Karampinos DC. Impact of baseline adipose tissue characteristics on change in adipose tissue volume during a low calorie diet in people with obesity-results from the LION study. Int J Obes (Lond). 2024 Sep;48(9):1332-1341. doi: 10.1038/s41366-024-01568-6. Epub 2024 Jun 26.
- Results publication: PubMed 38809148Somasundaram A, Wu M, Reik A, Rupp S, Han J, Naebauer S, Junker D, Patzelt L, Wiechert M, Zhao Y, Rueckert D, Hauner H, Holzapfel C, Karampinos DC. Evaluating Sex-specific Differences in Abdominal Fat Volume and Proton Density Fat Fraction at MRI Using Automated nnU-Net-based Segmentation. Radiol Artif Intell. 2024 Jul;6(4):e230471. doi: 10.1148/ryai.230471.
- Individual participant dataSharing planned: Yes. We will apply principles which meet standards of findability, accessibility, interoperability, and reusability (FAIR) in the management of data in our project. The owner of the data will be the Institute for Nutritional Medicine at TUM School of Medicine, Technical University of Munich. The data and samples will be safely stored for long term and can be easily accessed and/or downloaded by the study team. For collaboration partners defined dataset and samples will be provided with well-defined license and access conditions.
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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.
Christina Holzapfel, PhD principal investigator
TUM School of Medicine, Technical University of Munich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Weight maintenance intervention in people with Obesity, run by Technical University of Munich at 1 site in Germany.
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 6 inclusion and 18 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 4 Dec 2024. 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 Germany. 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?
Weight maintenance 12 months after weight loss intervention (time frame: 15 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 NCT04023942, which also lists 4 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 4 Dec 2024.