Nutritional and Metabolic DiseasesLIME-ANCT07868601
LIfestyle MEtabotype Study A
An observational study of Nutritional and Metabolic Diseases and Prediabetes, run by German Institute of Human Nutrition at 1 site in Germany.
Trial summary
Glycemic responses vary significantly among individuals, even when consuming identical foods or meals, but the factors predicting individual glucose response to food intake remain poorly investigated. Read more about this study
- Who is it for?
- Ages 40 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Nutritional and Metabolic Diseases, Prediabetes, Type 2 Diabetes
- Type of treatment
- Pill or oral medicine
- How many people
- 300 participants
- Where
- 1 siteGermany
- Study dates
- 10 Oct 2026to 31 Dec 2031
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 40 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adults (40-75 years) with overweight or obesity and with prediabetes or T2D or without prediabetes and T2D
Who may be able to join
- Overweight or obesity (BMI 25-40 kg/m²)
- Good knowledge of German
Who cannot join
- Weight changes of more than 5% in the last 3 months
- Night shift work
- Travel across more than one time zone in the last month before and during study participation
- Intensive regular physical activity of more than 2 hours per day
- Current pregnancy or breastfeeding
- Severe renal, liver or heart disease
Show all 26Show fewer
- Existing or past hematological malignancies, other malignant tumors, unless successfully treated more than 12 months before study start
- Severe neurological or psychiatric disorders
- Daily alcohol consumption of more than 20 grams or more than 150 grams per week
- Use of illicit or legal drugs one week prior to study start and during study participation
- Known systemic infections
- Type 1 diabetes and rare forms of diabetes
- Diabetes treatment with insulin or sulfonylureas or diabetes medication in the absence of manifest type 2 diabetes
- Unstable thyroid dysfunction
- Blood coagulation disorders or anticoagulation therapy that cannot be interrupted
- Medications affecting nutrient absorption
- Medications with immunosuppressants or steroids (oral or parenteral)
- Current eating disorders, functional or structural digestive disorders or bariatric surgery
- Food allergies or intolerances to ingredients of the test meals
- Intermittent fasting or calorie-restricted diet four weeks prior to the start of the study or during the study
- Ketogenic diet or ketogenic supplements four weeks prior to or during module B
- Left-handedness
- Severe claustrophobia
- Electrical implants or non-removable metallic implants
- Concurrent participation in another intervention study
- Assessment by the study physician based on medical concerns precluding study participation
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
German Institute of Human Nutrition, Dept. Molecular Metabolism and Precision Nutrition and Decision Neuroscience and Nutrition
Potsdam, Potsdam-Rehbrücke, 14558
Beeke Peters, MSc, +49 33200 882690, beeke.peters@dife.de
Eva Fröhlich, Dr., +49 33200 882511, eva.froehlich@dife.de
About this study
Official title: LIfestyle MEtabotype Study (Module A)
Glycemic responses vary significantly among individuals, even when consuming identical foods or meals, but the factors predicting individual glucose response to food intake remain poorly investigated.
The aim of the LIfestyle MEtabotype study (LIME) observational study is to identify lifestyle-related and mechanistic factors which predict individual postprandial glucose fluctuations in individuals with different glycemic status (prediabetes, type 2 diabetes [T2D], and absence of prediabetes or T2D). To address this aim, the study will conduct a comprehensive lifestyle characterization and metabolic, molecular and neurocognitive phenotyping during study center visits and a dietary, glucose, sleep and activity monitoring during the observational phase.
Read the detailed description
Studies show that glycemic responses vary significantly among individuals, even when consuming identical foods or meals. These varying glycemic responses are attributed to metabolic differences between individuals. Recently, machine learning models incorporating metabolic data (including microbiome composition) have been able to successfully predict individual blood glucose responses. Precision nutrition recommendations based on such predictions could facilitate better glycemic control and reduce the risk of diabetes. From this perspective, considering metabolic biomarkers, phenotype and genotype, as well as gut microbiome composition, could play a role in deriving dietary recommendations and thereby achieving the best possible health outcomes through nutrition. In addition to macronutrient composition, the timing, frequency and number of meals may also play a significant role in the glycemic response to diet. Finally, socioeconomic, cultural and personal lifestyle factors also have an influence on the glycemic response. Therefore, this study aims to characterize the personal lifestyle differences between individuals with prediabetes, T2D, and those without prediabetes or T2D.
Furthermore, ketone bodies, specifically β-hydroxybutyrate (βHB), are gaining importance, as they serve as both metabolic biomarkers and alternative energy sources in periods of low carbohydrate availability. In individuals with insulin resistance or prediabetes, cerebral glucose utilization is often impaired; leading to the use of ketone bodies as a compensatory energy source for the brain. Findings indicate that the individual ketone response to dietary interventions varies significantly between individuals and could thus itself be relevant as a metabolic phenotype marker in the context of precision nutrition. Therefore, the study also aims to further investigate the extent to which exogenous βHB supplementation influences neurocognitive processes and decision-making behavior, and whether characteristic neurocognitive phenotypes can be derived from this in metabolic risk groups.
This study will achieve its aims by completing a comprehensive lifestyle characterization and metabolic, molecular and neurocognitive phenotyping of individuals with different glycemic status (prediabetes, type 2 diabetes [T2D], and absence of prediabetes or T2D) in a German cohort. The study consists of modules A and B.
This record represents a description of module A which includes a 14-days observational period at home and two visits (screening and phenotyping visits) of the study center at the German Institute for Human Nutrition Potsdam-Rehbrueke before and after the observational period, respectively. In the observation period, food intake, sleep, activity, and interstitial glucose will be monitored during 14 days, and test meals will be consumed at two days at specific times. Study visits of module A include the intensive characterization using questionaries, anthropometric and metabolic assessments as well as collection of biosamples.
Module B has an interventional crossover design and is registered an a separate record. Module B takes place 1-12 weeks after module A and include two visits of the study center at the Free University of Berlin, separated by a two-week interval. Study visits of module B will focus on neurocognitive phenotyping including MRI of brain anatomy, function and complete computer-based decision-making behavior tests, and a consumption of the test drink containing ketone β-hydroxybutyrate (βHB) (test and placebo visits).
The aims of the study are as follows:
Primary aims:
- Identification of metabolic biomarkers and omics-based scores that predict individual glycemic response to food
- Identification of general lifestyle patterns that distinguish individuals with prediabetes or T2D from those without prediabetes or T2D
- Identification of personal factors and differences in lifestyle patterns that predict individual glucose response to food
Secondary aim:
- Elucidation of neuronal, metabolic, and molecular mechanisms associated with specific lifestyle patterns
- Keywords
- Prediabetes, Type 2 Diabetes, Metabolism, Lifestyle, Glycemic response, Eating timing
- Medical subject headings
- Nutritional and Metabolic Diseases, Prediabetic State, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Group A (without Prediabetes or Type 2 Diabetes) | HbA1c <5.7% and fasting plasma glucose < 100 mg/dl | |
| Group B (Prediabetes) | HbA1c 5.7-6.4%, or fasting plasma glucose 100-125 mg/dL | |
| Group C (Type 2 Diabetes) | HbA1c ≥6.5%, fasting plasma glucose ≥ 126 mg/dl, or existing T2D diagnosis by physician, or T2D diagnosis based on an available result from standardized 75 g oral glucose tolerance test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glucose incremental Area Under the Curve (iAUC) after a morning test meal
Glucose iAUC [mg/dL⋅min] measured using continuous glucose monitoring (CGM) after a standardized morning test meal as an average of two test days within the observation period
Measured: 3 and 10 days
Secondary outcomes (46)
Body height
Body height [m] measured using a stadiometer or calibrated wall-mounted measuring tape
Measured: 2 weeks
Body weight
Body weight [kg] measured by scale weight
Measured: 2 weeks
Waist and hip circumference
Waist and hip circumference [cm] measured using tape
Measured: 2 weeks
Body Mass Index (BMI)
BMI [kg/m2], calculated as weight/square height
Measured: 2 weeks
Body composition
Fat and muscle mass [kg] measured by bioelectrical impedance analysis (BIA)
Measured: 2 weeks
Basal metabolic rate
Basal metabolic rate [kcal/day] assessed by indirect calorimetry
Measured: 2 weeks
Handgrip strength
Maximal isometric handgrip strength [kg] as measured by a hand-dynamometers
Measured: 2 weeks
Blood pressure
Systolic and diastolic blood pressure [mm Hg], as measured by a blood pressure monitor
Measured: 2 weeks
Fasting glucose
Glucose levels [mg/dL] assessed in fasting blood samples
Measured: 2 weeks
HbA1c
HbA1c levels [%] assessed in fasting blood samples
Measured: 2 weeks
Concentration of metabolic hormones
Insulin, C-peptide, glucagon, leptin and adiponectin levels [ng/mL] assessed in fasting blood samples
Measured: 2 weeks
Concentration of blood lipids
Total cholesterol, low-density lipoprotein (LDL), high-density lipoprotein cholesterol (HDL), triglycerides [mg/dL] and lipidomic-based lipid patterns assessed in fasting blood samples
Measured: 2 weeks
Concentration of inflammatory markers
Interleukin-6 and hsCRP levels [mg/L] measured in blood samples
Measured: 2 weeks
Concentration of liver enzymes
γ-glutamyltransferase (GGT), aspartate aminotransferase (AST), and alanine aminotransferase (ALT) levels [U/L] determined in fasting blood samples
Measured: 2 weeks
Concentration of kidney parameters
Creatinine, urea, uric acid levels [mg/dL] determined in fasting blood samples
Measured: 2 weeks
Concentration of blood metabolites
Metabolite levels measured by metabolomic analysis in blood samples
Measured: 2 weeks
Gene expression in blood mononuclear cells (PBMC)
Gene expression assessed by RNA-Seq or qPCR analysis in PBMC
Measured: 2 weeks
Gene expression in subcutaneous adipose tissue (SAT)
Gene expression assessed by RNA-Seq or qPCR analysis in SAT
Measured: 2 weeks
Immune cell composition in PBMC and SAT
Immune cell composition measured using FACS analysis
Measured: 2 weeks
Gut microbiome composition
Gut microbiome species as assessed by 16S rRNA gene sequencing of stool samples
Measured: 2 weeks
Gut microbiome metabolites
Levels of microbiome-derived metabolites measured in stool samples
Measured: 2 weeks
Mean glucose
Mean glucose level [mg/dL] measured using CGM
Measured: 2 weeks
Glycemic variability
Intra- and inter-day glycemic fluctuation indices [AU] from CGM measurement
Measured: 2 weeks
Time in range (TIR)
TIR [%] from CGM measurement
Measured: 2 weeks
Glucose Management Indicator (GMI, estimated HbA1c)
GMI [%] from CGM measurement
Measured: 2 weeks
Glucose Area Under the Curve (AUC) after a morning test meal
Glucose AUC [mg/dL⋅min] measured using CGM after a standardized morning test meal as an average of two test days within the observation period
Measured: 3 and 10 days
Glucose AUC and iAUC after an evening test meal
Glucose AUC and iAUC [mg/dL⋅min] is measured using CGM after a standardized evening test meal as an average of two test days within the observation period
Measured: 5 and 12 days
Eating timing and composition
Food type, quality, meal times and nutrient composition assessed by digital or paper-based food records
Measured: 2 weeks
Physical activity
24-hour physical activity monitored by actigraphy
Measured: 2 weeks
Sleep timing
Sleep timing (sleep onset and offset [hh:mm]) and sleep duration as monitored using a sleep diary and actigraphy
Measured: 2 weeks
Objective sleep quality
Sleep quality as assessed by actigraphy
Measured: 2 weeks
Light exposure
24-hour light exposure [lux] as monitored by actigraphy
Measured: 2 weeks
Body temperature
24-hour body temperature [°C] will be monitored by actigraphy
Measured: 2 weeks
Subjective sleep quality
Sleep quality as assessed by the Pittsburgh Sleep Quality Index (PSQI score, which ranges from 0-21, where higher values correspond to worse sleep quality)
Measured: 2 weeks
Chronotype
Chronotype assessed by the Munich Chronotype Questionnaire (MSFsc time, where later values correspond to later chronotype) and Morning-Eveningness Questionnaire (D-MEQ score, which ranges 19-76, where higher values correspond to later chronotype)
Measured: 2 weeks
Body awareness
Body awareness assessed by the Multidimensional Assessment of Interoceptive Awareness (MAIA-2) and list of subjective hypoglycemia symptoms. The MAIA-2 provides subscale scores (across 8 dimensions) ranging from 1 to 5, where higher values correspond to greater interoceptive awareness and sensitivity to internal body signals
Measured: 2 weeks
Eating Behavior
Eating behavior as assessed by the Dutch Eating Behavior Questionnaire (DEBQ). The DEBQ provides three distinct subscale scores-Emotional, External, and Controlled eating-each ranging from 1 to 4, where higher values correspond to greater prevalence of that specific eating behavior.
Measured: 2 weeks
Emotional eating
Emotional eating behavior as assessed using the Salzburg Emotional Eating Scale (SEES). The SEES provides a score ranging from 1 to 5, where higher values correspond to greater frequency of emotional eating.
Measured: 2 weeks
Food Timing
Food timing assessed using the Food Timing Screener (FTS) questionnaire, which provides timing of main meals and snacks [hh:mm]
Measured: 2 weeks
Subjective feelings of hunger and satiety
Satiety and hunger scores assessed using Visual Analog Scales (VAS) before and after standardized test meals. VAS scores range from 0 to 100 mm, where higher values correspond to increased levels of hunger or fullness, respectively.
Measured: 3, 5, 10 and 12 days
Health-related quality of life
Health-related quality-of-life, as assessed by the 36-Item Short Form Health Survey (SF-36), which provides standardized scores ranging from 0 to 100, where higher values correspond to better health-related quality of life
Measured: 2 weeks
Affective states
Affective states as assessed with the Positive and Negative Affect Schedule (PANAS). The PANAS provides two subscale scores (Positive Affect and Negative Affect) ranging from 1 to 5, where higher values correspond to increased levels of positive or negative affect, respectively
Measured: 2 weeks
Perceived stress
Perceived stress as assessed using the Perceived Stress Questionnaire (PSQ), which provides a score ranging from 0 to 40, where higher values correspond to greater levels of perceived stress
Measured: 2 weeks
Anxiety
Anxiety levels as assessed using State-Trait Anxiety Inventory (STAI), which provides two subscale scores (State and Trait) ranging from 20 to 80, where higher values correspond to greater levels of state or trait anxiety, respectively
Measured: 2 weeks
Depression
Depression levels as assessed using the Beck Depression Inventory (BDI) and the Health Questionnaire for Patients (PHQ-D). The BDI provides a score ranging from 0 to 63, where higher values correspond to greater severity of depressive symptoms. The PHQ-9 provides a score ranging from 0 to 27, where higher values correspond to greater severity of depressive symptoms.
Measured: 2 weeks
Motivation
Motivation levels as assessed using the Behavioral Inhibition and Activation (BISBAS). The BIS/BAS provides three subscale scores (BIS, BAS-Reward Responsiveness, and BAS-Impulsivity) ranging from 8 to 32, where higher values correspond to greater sensitivity to threat or reward, respectively
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2026
- Study start10 Oct 2026 (estimated)
- Primary completion31 Dec 2030 (estimated)
- Study completion31 Dec 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nutritional and Metabolic DiseasesStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- German Institute of Human Nutrition
- Sponsor type
- University, hospital or other
- Collaborators
- Freie Universität Berlin, Center for Cognitive Neuroscience Berlin (CCNB), German Center of Diabetes Research (DZD)
- Responsible party
- Principal investigator, Olga Ramich (formerly Pivovarova), German Institute of Human Nutrition
- Investigators
- Olga Ramich, Prof. Dr., Principal investigator, German Institute of Human Nutrition Potsdam-Rehbruecke and the Charité - Universitätsmedizin BerlinSoyoung Park, Prof. Dr., Principal investigator, German Institute of Human Nutrition Potsdam-Rehbrücke and the Charité - Universitätsmedizin Berlin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07868601
- Sponsor's protocol ID
- 2026-91-BO-ff
- Acronym
- LIME-A
- Status last verified
- Oct 2026
- First submitted
- 28 Sep 2026
- Last updated
- 9 Oct 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 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- LIfestyle MEtabotype Study (Module A)
- ClinicalTrials.gov ID
- NCT07868601
- Acronym / sponsor ID
- LIME-A / 2026-91-BO-ff
- Keywords
- Prediabetes, Type 2 Diabetes, Metabolism, Lifestyle, Glycemic response, Eating timing
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- German Institute of Human NutritionUniversity, hospital or other
- Collaborators
- Freie Universität Berlin, Center for Cognitive Neuroscience Berlin (CCNB), German Center of Diabetes Research (DZD)
- Study start
- 10 Oct 2026 (estimated)
- Primary completion
- 31 Dec 2030 (estimated)
- Study completion
- 31 Dec 2031 (estimated)
- First posted
- 9 Oct 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.
Glycemic responses vary significantly among individuals, even when consuming identical foods or meals, but the factors predicting individual glucose response to food intake remain poorly investigated.
The aim of the LIfestyle MEtabotype study (LIME) observational study is to identify lifestyle-related and mechanistic factors which predict individual postprandial glucose fluctuations in individuals with different glycemic status (prediabetes, type 2 diabetes [T2D], and absence of prediabetes or T2D). To address this aim, the study will conduct a comprehensive lifestyle characterization and metabolic, molecular and neurocognitive phenotyping during study center visits and a dietary, glucose, sleep and activity monitoring during the observational phase.
Detailed description
Studies show that glycemic responses vary significantly among individuals, even when consuming identical foods or meals. These varying glycemic responses are attributed to metabolic differences between individuals. Recently, machine learning models incorporating metabolic data (including microbiome composition) have been able to successfully predict individual blood glucose responses. Precision nutrition recommendations based on such predictions could facilitate better glycemic control and reduce the risk of diabetes. From this perspective, considering metabolic biomarkers, phenotype and genotype, as well as gut microbiome composition, could play a role in deriving dietary recommendations and thereby achieving the best possible health outcomes through nutrition. In addition to macronutrient composition, the timing, frequency and number of meals may also play a significant role in the glycemic response to diet. Finally, socioeconomic, cultural and personal lifestyle factors also have an influence on the glycemic response. Therefore, this study aims to characterize the personal lifestyle differences between individuals with prediabetes, T2D, and those without prediabetes or T2D.
Furthermore, ketone bodies, specifically β-hydroxybutyrate (βHB), are gaining importance, as they serve as both metabolic biomarkers and alternative energy sources in periods of low carbohydrate availability. In individuals with insulin resistance or prediabetes, cerebral glucose utilization is often impaired; leading to the use of ketone bodies as a compensatory energy source for the brain. Findings indicate that the individual ketone response to dietary interventions varies significantly between individuals and could thus itself be relevant as a metabolic phenotype marker in the context of precision nutrition. Therefore, the study also aims to further investigate the extent to which exogenous βHB supplementation influences neurocognitive processes and decision-making behavior, and whether characteristic neurocognitive phenotypes can be derived from this in metabolic risk groups.
This study will achieve its aims by completing a comprehensive lifestyle characterization and metabolic, molecular and neurocognitive phenotyping of individuals with different glycemic status (prediabetes, type 2 diabetes [T2D], and absence of prediabetes or T2D) in a German cohort. The study consists of modules A and B.
This record represents a description of module A which includes a 14-days observational period at home and two visits (screening and phenotyping visits) of the study center at the German Institute for Human Nutrition Potsdam-Rehbrueke before and after the observational period, respectively. In the observation period, food intake, sleep, activity, and interstitial glucose will be monitored during 14 days, and test meals will be consumed at two days at specific times. Study visits of module A include the intensive characterization using questionaries, anthropometric and metabolic assessments as well as collection of biosamples.
Module B has an interventional crossover design and is registered an a separate record. Module B takes place 1-12 weeks after module A and include two visits of the study center at the Free University of Berlin, separated by a two-week interval. Study visits of module B will focus on neurocognitive phenotyping including MRI of brain anatomy, function and complete computer-based decision-making behavior tests, and a consumption of the test drink containing ketone β-hydroxybutyrate (βHB) (test and placebo visits).
The aims of the study are as follows:
Primary aims:
- Identification of metabolic biomarkers and omics-based scores that predict individual glycemic response to food
- Identification of general lifestyle patterns that distinguish individuals with prediabetes or T2D from those without prediabetes or T2D
- Identification of personal factors and differences in lifestyle patterns that predict individual glucose response to food
Secondary aim:
- Elucidation of neuronal, metabolic, and molecular mechanisms associated with specific lifestyle patterns
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A (without Prediabetes or Type 2 Diabetes) | – | –HbA1c <5.7% and fasting plasma glucose < 100 mg/dl |
| Group B (Prediabetes) | – | –HbA1c 5.7-6.4%, or fasting plasma glucose 100-125 mg/dL |
| Group C (Type 2 Diabetes) | – | –HbA1c ≥6.5%, fasting plasma glucose ≥ 126 mg/dl, or existing T2D diagnosis by physician, or T2D diagnosis based on an available result from standardized 75 g oral glucose tolerance test |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adults (40-75 years) with overweight or obesity and with prediabetes or T2D or without prediabetes and T2D
Key inclusion criteria (2 listed)
- Overweight or obesity (BMI 25-40 kg/m²)
- Good knowledge of German
Key exclusion criteria (26 listed)
- Weight changes of more than 5% in the last 3 months
- Night shift work
- Travel across more than one time zone in the last month before and during study participation
- Intensive regular physical activity of more than 2 hours per day
- Current pregnancy or breastfeeding
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Glucose incremental Area Under the Curve (iAUC) after a morning test meal
Time frame: 3 and 10 days
Glucose iAUC [mg/dL⋅min] measured using continuous glucose monitoring (CGM) after a standardized morning test meal as an average of two test days within the observation period
46 secondary outcomes
Body height
Time frame: 2 weeks
Body weight
Time frame: 2 weeks
Waist and hip circumference
Time frame: 2 weeks
Body Mass Index (BMI)
Time frame: 2 weeks
Body composition
Time frame: 2 weeks
Basal metabolic rate
Time frame: 2 weeks
Handgrip strength
Time frame: 2 weeks
Blood pressure
Time frame: 2 weeks
Fasting glucose
Time frame: 2 weeks
HbA1c
Time frame: 2 weeks
Concentration of metabolic hormones
Time frame: 2 weeks
Concentration of blood lipids
Time frame: 2 weeks
Concentration of inflammatory markers
Time frame: 2 weeks
Concentration of liver enzymes
Time frame: 2 weeks
Concentration of kidney parameters
Time frame: 2 weeks
Concentration of blood metabolites
Time frame: 2 weeks
Gene expression in blood mononuclear cells (PBMC)
Time frame: 2 weeks
Gene expression in subcutaneous adipose tissue (SAT)
Time frame: 2 weeks
Immune cell composition in PBMC and SAT
Time frame: 2 weeks
Gut microbiome composition
Time frame: 2 weeks
Gut microbiome metabolites
Time frame: 2 weeks
Mean glucose
Time frame: 2 weeks
Glycemic variability
Time frame: 2 weeks
Time in range (TIR)
Time frame: 2 weeks
Glucose Management Indicator (GMI, estimated HbA1c)
Time frame: 2 weeks
Glucose Area Under the Curve (AUC) after a morning test meal
Time frame: 3 and 10 days
Glucose AUC and iAUC after an evening test meal
Time frame: 5 and 12 days
Eating timing and composition
Time frame: 2 weeks
Physical activity
Time frame: 2 weeks
Sleep timing
Time frame: 2 weeks
Objective sleep quality
Time frame: 2 weeks
Light exposure
Time frame: 2 weeks
Body temperature
Time frame: 2 weeks
Subjective sleep quality
Time frame: 2 weeks
Chronotype
Time frame: 2 weeks
Body awareness
Time frame: 2 weeks
Eating Behavior
Time frame: 2 weeks
Emotional eating
Time frame: 2 weeks
Food Timing
Time frame: 2 weeks
Subjective feelings of hunger and satiety
Time frame: 3, 5, 10 and 12 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2026.
- Individual participant dataSharing planned: No
Related trials for Nutritional and Metabolic Diseases
RecruitingPhase 4
Translational Health Research Into Vascular and Neurocognitive Effects of Weight Loss
Class I/II Obesity
Recruiting
Clinical Study to Evaluate the Impact of the Accu-Chek SmartGuide CGM Solution on the Mean Change in Time in Range Compared With Self-Monitoring of Blood Glucose in Participants With Type 1 and Type 2 Diabetes Mellitus
Type 1 Diabetes Mellitus, Type 2 Diabetes Mellitus
Not yet recruitingPhase 2
Effects of Meal Macronutrients on Postprandial Lipids
Nephrotic Syndrome, Lipodystrophy
Not yet recruitingObservational study
Assessing the Impact of Perceptions of Unpredictability on Objective Measures of Food Consumption and Metabolism
Healthy Volunteer, Obestity
RecruitingPhase 1/2
A Phase 1/2a Study of WVE-007 in Adults Living With Overweight or Obesity
Overweight and Obesity
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.
Olga Ramich, Prof. Dr. principal investigator
German Institute of Human Nutrition Potsdam-Rehbruecke and the Charité - Universitätsmedizin Berlin
Soyoung Park, Prof. Dr. principal investigator
German Institute of Human Nutrition Potsdam-Rehbrücke and the Charité - Universitätsmedizin Berlin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Nutritional and Metabolic Diseases and Prediabetes, run by German Institute of Human Nutrition 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 2 inclusion and 26 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: looking for participants now, as of the sponsor's last update on 9 Oct 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 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Olga Ramich, Prof. Dr. (+49 33200 882749, olga.ramich@dife.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glucose incremental Area Under the Curve (iAUC) after a morning test meal (time frame: 3 and 10 days). 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 9 Oct 2026.