- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04023942
Personalized Nutrition and eHealth: Lifestyle Intervention (LION) Study for Weight Loss Maintenance (LION)
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.
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.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Bavaria
-
Munich, Bavaria, Germany, 80992
- Institute for Nutritional Medicine, Technical University of Munich
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Age: 18 - 65 years
- BMI: 30,0 - 39,9 kg/m2
- Owner of a smartphone
- Caucasian
- No severe diseases
- Informed written consent
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: Low carb - App-based group
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.
|
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).
Other Names:
|
ACTIVE_COMPARATOR: Low carb - Newsletter-based group
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.
|
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).
Other Names:
|
ACTIVE_COMPARATOR: Low fat - App-based group
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.
|
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).
Other Names:
|
ACTIVE_COMPARATOR: Low fat - Newsletter-based group
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.
|
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).
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Weight maintenance 12 months after weight loss intervention
Time Frame: 15 months
|
Body weight change in kg and % (from baseline weight)
|
15 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Weight change after eight weeks of formula diet
Time Frame: month 3
|
Body weight in kg and % (from baseline weight)
|
month 3
|
Glucose
Time Frame: month 0, 3, 6, 9, 12, 15, 27
|
Change in glucose in mg/dl
|
month 0, 3, 6, 9, 12, 15, 27
|
Insulin
Time Frame: month 0, 3, 6, 9, 12, 15, 27
|
Change in insulin in µU/ml
|
month 0, 3, 6, 9, 12, 15, 27
|
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
|
month 0, 3, 6, 9, 12, 15, 27
|
Leptin
Time Frame: month 0, 3, 6, 9, 12, 15, 27
|
Change in leptin in ng/ml
|
month 0, 3, 6, 9, 12, 15, 27
|
Resting metabolic rate
Time Frame: month 0, 3, 15, 27
|
Resting metabolic rate in kilocalories / 24 hours
|
month 0, 3, 15, 27
|
Magnetic resonance imaging (MRI)
Time Frame: month 0, 3, 15, 27
|
MRI data (organ volume, proton density fat fraction)
|
month 0, 3, 15, 27
|
Insulin response on meal challenges
Time Frame: month 0
|
Insulin response at different time points during meal challenge in µU/ml
|
month 0
|
Glucose response on meal challenges
Time Frame: month 0
|
Glucose response at different time points during meal challenge in mg/dl
|
month 0
|
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
|
month 0
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Christina Holzapfel, PhD, TUM School of Medicine, Technical University of Munich
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 01EA1709
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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