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CompletedNCT06860776Updated Jul 7, 2026

How Metabolism Affects Weight Loss and Gain

An observational study in Obesity and Overweight, sponsored by University Hospital Schleswig-Holstein. Completed at 1 site in Germany. Open to participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-07.

Sponsored by University Hospital Schleswig-Holstein · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
20
Ages
18 Years to 70 Years
Sex
All
01

Study summary

This study examines why some individuals with obesity have difficulty losing weight, whereas some lean individuals struggle to gain weight. The investigators will measure how the human body uses energy during a fasting period and after consumption of a specially designed, low-protein meal. By comparing these responses, the investigators aim to identify different "metabolic phenotypes" that affect weight control. Findings from this research may lead to more personalized treatments for managing weight. Participation in this study involves simple tests and basic body measurements.

Read the detailed description

This study aims to better understand why certain individuals find it difficult to lose weight while others struggle to gain weight. Investigators believe that differences in how the human body uses energy-referred to as the metabolic phenotype-may play a key role.

Two groups of participants will be compared: one group includes lean individuals who have difficulty gaining weight, and the other group consists of individuals with obesity who have difficulty losing weight. Participants will undergo a series of tests designed to measure how the human body burns calories under different conditions.

The study involves two main components:

  1. 24-Hour Fasting Period: Participants will abstain from eating for 24 hours to observe how the body adapts by either conserving or maintaining energy expenditure.
  2. Meal Test: Following the fasting period, participants will consume a specially designed, low-protein meal that simulates overeating. The investigators will measure how much additional energy is burned during digestion, a process known as diet-induced thermogenesis.

A technique called indirect calorimetry will record oxygen consumption and carbon dioxide production. These measurements help calculate resting energy expenditure (REE), which refers to the calories the body burns while at rest, and any changes that occur after fasting and eating.

The goal is to identify distinct metabolic patterns. Some individuals may have a "thrifty" metabolism that conserves energy, making weight loss more challenging, whereas others may have a "spendthrift" metabolism that expends more energy, potentially explaining difficulty in gaining weight. Understanding these differences could lead to more personalized and effective weight management strategies.

This study is conducted under strict safety and ethical standards to ensure minimal risk to participants. By examining the relationship between metabolism and weight control, the findings may pave the way for improved treatments for obesity and related weight issues.

02

Conditions studied

  • Obesity and Overweight

Keywords

  • obesity
  • metabolic phenotype
  • thrifty
  • spendthrift
  • diet-induced thermogenesis
  • fasting
  • indirect calorimetry
03

In context

Obesity

11,522 studies on the registry are indexed under Obesity; 2,033 are open to participants now.

This study's enrollment of 20 is below the median of 114 across 2,154 observational studies indexed under Obesity.

Browse Obesity studies →

Lead sponsor

University Hospital Schleswig-Holstein is the lead sponsor of 163 studies on the registry; 25 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Participants will be recruited from the general adult population, focusing on two specific groups:

  1. Lean individuals (BMI 18.5-22.0 kg/m²) who struggle to gain weight
  2. Individuals with obesity (BMI >30 kg/m²) who struggle to lose weight

All participants must be generally healthy, between 18 and 70 years old, and report a stable body weight (less than 5% fluctuation) in the last six months. Recruitment will occur via community outreach, advertisements, and existing volunteer registries. Potential participants with conditions or circumstances that could affect appetite, energy expenditure, or study compliance will be excluded.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Group 1 (Lean): 18.5-22.0 kg/m², reporting difficulty gaining weight
  • Group 2 (Obese): BMI >30 kg/m², reporting difficulty losing weight
  • Healthy status as determined by medical history, physical examination, and laboratory tests
  • Stable weight (less than 5% fluctuation) over the past 6 months

Exclusion criteria

Exclusion Criteria:

  • Prediabetes ( >5.6% or fasting blood glucose >100 mg/dL) or diabetes mellitus
  • Conditions affecting appetite or energy expenditure (e.g., Cushing's syndrome, uncontrolled hyper-/hypothyroidism)
  • Gastrointestinal disorders that impact nutrient absorption (e.g., inflammatory bowel disease, malabsorption syndromes, ulcers)
  • Psychiatric conditions influencing eating behavior (e.g., active depression, anorexia nervosa, bulimia nervosa, borderline personality disorder)
  • Acute, unstable cardiovascular disease requiring hospitalization within the last 6 months (e.g., stent placement)
  • Cancer that required treatment in the past 5 years
  • Chronic kidney disease (Stage IV or higher, per NKF criteria)
  • Active infectious disease (e.g., , hepatitis)
  • Current nicotine use or nicotine use within the last month prior to screening
  • Illicit drug use (e.g., amphetamines, cocaine, heroin, marijuana)
  • Regular high-intensity physical activity (≥1 hour/day)
  • Non-MRI-compatible metallic implants (e.g., artificial joints, metal plates)
  • Pregnancy or breastfeeding
  • Use of weight-loss medications
  • claustrophobia
  • Any other condition not mentioned above that, in the opinion of the investigator, could interfere with study participation or compromise patient safety
Terms in these criteria, in plain language(4)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

HbA1c

A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
20 participants (actual)
Patient registry
No
Biospecimen retention
Samples without dna

Groups and cohorts

  • Lean individual with weight gain difficulties

    Participants in this group are lean individuals (BMI 18.5-22.0 kg/m²) who have difficulty gaining weight. They will undergo a 24-hour fasting period followed by a controlled low-protein, high-calorie meal test. Researchers will measure their resting metabolic rate before and after fasting, as well as the body's response to the test meal. By comparing these results to those of other groups, the study aims to identify metabolic factors that influence weight gain difficulties and guide future personalized treatments.

  • Individuals with obesity and weight loss difficulties

    Participants in this group are individuals with obesity (BMI \>30 kg/m²) who have difficulty losing weight. They will undergo a 24-hour fasting period followed by a controlled low-protein, high-calorie meal test. Researchers will measure their resting metabolic rate before and after fasting, as well as the body's response to the test meal. By comparing these findings with those of other groups, the study seeks to uncover metabolic factors that contribute to weight loss difficulties and guide more personalized treatment approaches.

06

What researchers measure

Primary outcomes

  1. Identification of Metabolic Phenotypes in Lean vs. Obese Individuals

    We aim to determine whether individuals with obesity (BMI \>30 kg/m²) exhibit a more "thrifty" metabolic phenotype (lower resting metabolic rate \[RMR\] after 24-hour fasting and reduced diet-induced thermogenesis \[DIT\]) compared to lean individuals (BMI 18.5-22 kg/m²) who have trouble gaining weight, hypothesized to show a more "spendthrift" metabolic phenotype (increased RMR after fasting and higher DIT). RMR is measured via indirect calorimetry before and after a 24-hour fast, followed by a high-calorie, low-protein meal test to assess DIT.

    Time frame: Measured at baseline (Day 1) and after 24-hour fasting (Day 2)

Secondary outcomes

  1. Correlation Between Fasting-Induced Energy Expenditure Changes and Diet-Induced Thermogenesis

    Evaluate how the change in resting metabolic rate (RMR) after a 24-hour fast relates to diet-induced thermogenesis (DIT) following a high-calorie, low-protein meal. This will clarify the interaction between fasting adaptation and meal-related energy expenditure in lean vs. obese individuals.

    Time frame: Baseline (Day 1), post-fasting (Day 2), and after the meal test (Day 2)

  2. Assessment of Metabolic Flexibility via Respiratory Quotient

    Determine whether individuals with obesity show a smaller shift in their respiratory quotient (RQ) after fasting and the meal test, indicating lower metabolic flexibility compared to lean participants.

    Time frame: Baseline (Day 1), post-fasting (Day 2), and after the meal test (Day 2)

  3. Correlation Between Weight Gain at 12-Month Follow-Up and Initial Metabolic Phenotype

    Body weight (in kilograms) will be measured at baseline and again after 12 months using a calibrated scale. The correlation between weight change over this period and the initial metabolic phenotype (classified as "thrifty" or "spendthrift") will be assessed. The metabolic phenotype is determined by changes in resting metabolic rate (RMR) and diet-induced thermogenesis (DIT), both measured via indirect calorimetry.

    Time frame: 12-month follow-up

  4. Correlation Between Weight Gain at 12-Month Follow-Up and Diet-Induced Thermogenesis

    Body weight (in kilograms) will be measured at baseline and again after 12 months using a calibrated scale. The correlation between weight change over this period and the magnitude of diet-induced thermogenesis (DIT) will be assessed. DIT is determined via indirect calorimetry after a controlled, low-protein meal. This assessment will help identify whether higher or lower DIT predicts long-term weight change.

    Time frame: 12-month follow-up

  5. Correlation Between Meal Test Diet-Induced Thermogenesis and Fibroblast Growth Factor 21 (FGF-21) Secretion

    Fibroblast Growth Factor 21 (FGF-21) levels (in picograms per milliliter) will be measured in blood samples collected after the high-calorie, low-protein meal. The correlation between FGF-21 levels and diet-induced thermogenesis (DIT) will be assessed. DIT is measured using indirect calorimetry to quantify energy expenditure following the meal. This analysis will help determine whether FGF-21 may serve as a biomarker of metabolic adaptation.

    Time frame: After the meal test (Day 2)

  6. Correlation Between Gut Hormones and Changes in Energy Expenditure

    Serum levels of gut hormones (e.g., ghrelin, glucagon-like peptide-1 \[GLP-1\]) will be measured in picograms per milliliter. Resting metabolic rate (RMR) and diet-induced thermogenesis (DIT) will be assessed via indirect calorimetry before and after a 24-hour fast, as well as after a high-calorie, low-protein meal. The correlation between gut hormone levels and changes in energy expenditure (RMR and DIT) will be evaluated to investigate hormonal influences on metabolic responses.

    Time frame: Baseline (Day 1), after 24-hour fast (Day 2), and after the meal test (Day 2)

07

Study locations

1 site
  • University Hospital Schleswig-Holstein
    Kiel, Schleswig-Holstein 24105, Germany
08

References and documents

Individual participant data

Plan to share: Undecided

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Sep 2024 to primary completion in Mar 2026, 17 months.

Of 791 non-industry observational studies under Obesity, half reached primary completion within 40 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 106. This study's 17 months is below that.

Counting every sponsor, half of 836 studies reached it within 39 months; a quarter within 17 and three quarters within 96.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 28, 2025
First posted
Mar 6, 2025
StartActual
Sep 16, 2024
Primary completionActual
Mar 1, 2026
CompletionActual
Mar 1, 2026
Last update
Jul 7, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 7, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06860776
Responsible party
Tim Hollstein (Principal Investigator, University Hospital Schleswig-Holstein) — Principal investigator
First posted
Mar 6, 2025
Start date
Sep 16, 2024
Primary completion
Mar 1, 2026
Completion
Mar 1, 2026
Last update
Jul 7, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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