Trial document




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  DRKS00017819

Trial Description

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Title

Lifestyle intervention study

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Trial Acronym

LION

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URL of the Trial

http://www.enable-cluster.de/lion

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Brief Summary in Lay Language

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.

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Brief Summary in Scientific Language

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

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Do you plan to share individual participant data with other researchers?

Yes

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Description IPD sharing plan:

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. On request participant data collected during the trial, after deidentification and according to informed consent. Immediately following publication. No end date. On request to principle investigator (Christina Holzapfel, christina.holzapfel@tum.de).

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Organizational Data

  •   DRKS00017819
  •   2019/12/18
  •   2019/07/11
  •   yes
  •   Approved
  •   69/19 S-SR, Ethik-Kommission der Fakultät für Medizin der Technischen Universität München
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Secondary IDs

  •   NCT04023942  (ClinicalTrials.gov)
  •   01EA1709  (Technische Universität München)
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Health Condition or Problem studied

  •   E65-E68 -  Obesity and other hyperalimentation
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Interventions/Observational Groups

  •   Active Comparator: Low carb - App-based group
    Low carb diet for 12 months. In addition, participants are supervised by a mobile application (app).
  •   Active Comparator: Low carb - Newsletter-based group

    Low carb diet for 12 months. In addition, participants are supervised by a newsletter.
  •   Active Comparator: Low fat - App-based group
    Low fat diet for 12 months. In addition, participants are supervised by a mobile application (app).
  •   Active Comparator: Low fat - Newsletter-based group
    Low fat diet for 12 months. In addition, participants are supervised by a newsletter.
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Open (masking not used)
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  •   Active control (effective treament of control group)
  •   Treatment
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

- Weight maintenance 12 months after weight loss intervention; time frame: 15 months; Body weight change in kg and % (from baseline weight)

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Secondary Outcome

- Weight change after eight weeks of formula diet; time frame: month 3; Body weight in kg and % (from baseline weight)
- Glucose; time frame: month 0, 3, 6, 9, 12, 15, 27; Change in glucose in mg/dl
- Insulin; time frame: month 0, 3, 6, 9, 12, 15, 27; Change in insulin in µU/ml
- Lipids; time frame: month 0, 3, 6, 9, 12, 15, 27; Change in blood lipids (total cholesterin, triglyzeride, HDL cholesterin, LDL cholesterin - highly correlated to each other) in mg/dl
- Leptin; time frame: month 0, 3, 6, 9, 12, 15, 27; Change in leptin in ng/ml
- Resting metabolic rate; time frame: month 0, 3, 15, 27; Resting metabolic rate in kilocalories / 24 hours
- Magnetic resonance imaging (MRI); time frame: month 0, 3, 15, 27; MRI data (organ volume, proton density fat fraction)
- Insulin response on meal challenges; time frame: month 0; Insulin response at different time points during meal challenge in µU/ml
- Glucose response on meal challenges; time frame: month 0; Glucose response at different time points during meal challenge in mg/dl
- Lipid response on meal challenges; time frame: month 0; Lipid (total cholesterin, triglyzeride, HDL cholesterin, LDL cholesterin - highly correlated to each other) response at different time points during meal challenge in mg/dl

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2019/07/31
  •   252
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   65   Years
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Additional Inclusion Criteria

- Age: 18 - 65 years

- BMI: 30,0 - 39,9 kg/m2

- Owner of a smartphone

- Caucasian

- No severe diseases

- Informed written consent

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Exclusion Criteria

- Diabetes mellitus

- Severe cardiovascular and/or respiratory disease

- Untreated high blood pressure

- Severe kidney disease

- Active cancer (or in remission)

- Inflammatory bowel disease

- 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

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Addresses

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    • Technische Universität München
    • 80333   München
    • Germany
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    • Klinikum rechts der Isar, Technische Universität München, Institut für Ernährungsmedizin
    • Ms.  Dr.  Christina  Holzapfel 
    • Georg-Brauchle-Ring 62
    • 80992  München
    • Germany
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    • Klinikum rechts der Isar, Technische Universität München, Institut für Ernährungsmedizin
    • Ms.  Dr.  Christina  Holzapfel 
    • Georg-Brauchle-Ring 62
    • 80992  München
    • Germany
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Sources of Monetary or Material Support

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    • Bundesministerium für Bildung und Forschung (BMBF)
    • 11055  Berlin
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.