Lifestyle Metabotype Study B: Understanding Personalized Glucose Responses

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The LIME-B study seeks factors that predict individual postprandial glucose fluctuations using detailed lifestyle profiling and metabolic, molecular, and neurocognitive phenotyping. It examines the role of ketone bodies as an alternative brain energy source and how exogenous β-hydroxybutyrate might influence decision-making. Participants are classified into three glycemic groups (no prediabetes/diabetes, prediabetes, and type 2 diabetes) and receive a βHB ketone ester drink and a carbohydrate drink to assess responses. The study will integrate data on diet timing, microbiome, metabolic biomarkers, and cognitive processes to inform precision nutrition approaches. The investigation is conducted with multiple German institutions focused on nutrition, neuroscience, and diabetes research.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Overweight or obese (BMI 25-40 kg/m²)
* Good knowledge of German
* Completion of the LIME screening visit; participants who do not take part in the further assessments of module A \[NCT07868601\] may still participate in module B

Participants are classified into three groups based on the screening visit:

* Group A (without Prediabetes or Type 2 Diabetes) Criteria: HbA1c \<5.7% and fasting plasma glucose \< 100 mg/dl
* Group B (Prediabetes) Criteria: HbA1c 5.7-6.4%, or fasting plasma glucose 100-125 mg/dL
* Group C (Type 2 Diabetes) Criteria: 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

Exclusion Criteria:

* 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
* 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

Where it's running

• Freie Universität Berlin, Center for Cognitive Neuroscience Berlin (CCNB)
  Berlin, Germany Recruiting
• German Institute of Human Nutrition
  Nuthetal, Germany Recruiting

Study contacts

• Principal investigator: Olga Ramich, Prof. Dr. — German Institute of Human Nutrition Potsdam-Rehbrücke and the Charité - Universitätsmedizin Berlin
• Study coordinator: Soyoung Q Park, Prof. Dr.
• Email: soyoung.park@dife.de
• Phone: +49 33200 882510

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Lifestyle Metabotype Study: How Daily Habits Shape Blood Sugar

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• PortionSize Ed mobile program to support healthier eating after a recent stroke for people with prediabetes or type 2 diabetes

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• Whole Food for Families: a family whole-foods diet program to prevent type 2 diabetes

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• Comparing ketogenic and low-fat diets for diabetes management

  This study tests whether a ketogenic diet or a low-fat diet works better for managing blood sugar and overall health in people with type 2 diabetes or prediabetes.

  Recruiting University of New Mexico · Albuquerque, New Mexico · NCT06115265

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.