Overweight and ObesityTIMEXNCT05768958
Hedonic and Homeostatic Appetite Control in Obesity and Type 2 Diabetes in the Context of Meal and Exercise Timing
A study testing Exercise in people with Overweight and Obesity and Type 2 Diabetes, run by Steno Diabetes Center Copenhagen at 1 site in Denmark.
Trial summary
The overall aim is to investigate effects of acute exercise on ad libitum energy intake and study whether this differs between morning and evening in individuals with overweight/obesity with or without type 2 diabetes (T2D). Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight and Obesity, Type 2 Diabetes
- What is being tested?
- Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteDenmark
- Study dates
- 22 Mar 2023to 31 Jul 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults with overweight or obesity (BMI >25 kg/m2) with and without T2D
- HbA1c ≥48 mmol/mol for people with T2D
Who cannot join
- Not able to eat ad libitum meal
- Not able to perform the exercise bout
- Daily smoking
- For women: Pregnancy / planned pregnancy (within the study period) / lactating
- Self-reported history of an eating disorder in the past 3 years
- Self-reported weight change (>5 kg) within three months prior to inclusion
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- Treatment with antidepressants
- Treatment with fast acting insulin, combination insulin products and sulfonylureas
- Alcohol/drug abuse or in treatment with disulfiram (antabus) at time of inclusion
- Uncontrolled medical issues including but not limited to cardiovascular pulmonary, rheumatologic, hematologic, oncologic, infectious, gastrointestinal, or psychiatric disease; diabetes or other endocrine disease; immunosuppression
- Current treatment with medication which significantly affect appetite or energy balance (e.g., GLP-1 receptor agonists)
- Bariatric surgery
- Unable to understand the informed consent and the study procedures
- Concomitant participation in intervention studies
- Incapable of understanding Danish
Trial locations and contacts
1 site in 1 country.
About this study
The overall aim is to investigate effects of acute exercise on ad libitum energy intake and study whether this differs between morning and evening in individuals with overweight/obesity with or without type 2 diabetes (T2D). Furthermore, the aim is to examine the role of hedonic and homeostatic drivers of appetite control in obesity and T2D in the context of meal and exercise timing.
Read the detailed description
Fifty-eight adults (age 18 - 75 years old) with overweight/obesity (BMI >25 kg/m2) and with/without T2D will participate in this randomized cross-over study. Participants will complete two visits in the morning and two in the evening with a minimum of 3 days washout. The visits will include ratings of subjective appetite and blood samples in the fasted state followed by either a 45 min exercise bout or rest for the same duration. 15 min after the termination of the exercise bout/rest period the participants will be presented with an ad libitum meal for assessment of energy intake (primary outcome). Then the participants will complete the Steno Biometric Food Preference Task (SBFPT); A computerized task measuring food choice, explicit liking, and implicit and explicit wanting with concomitant biometric measurements. Throughout the visits, subjective appetite will be rated using visual analogue scales and blood will be collected for assessment of appetite-related hormones and metabolites.
(Time: -60 minutes (fasting), -45 minutes (start exercise/rest), 0 minutes (finish exercise/rest), 15 minutes (ad libitum meal), 30 minutes (finish al libitum meal), 60 minutes (end of visit)
Descriptive data will be collected at a visit prior to the test days. These data include body weight (kg), Body Mass Index (BMI, kg/m2), fat mass (kg), fat free mass (kg), fat percentage (%), HbA1c (mmol/mol and %), waist circumference (cm), VO2-0peak and ECG. The participants will furthermore fill in questionnaires regarding the following: Socio-Economic Status (SES), Control Over Eating (CoEQ), Munich Chronotype Questionnaire (MCTQ), Physical Activity Questionnaires (IPAQ), Pittsburgh Sleep Quality Index (PSQI). In addition to the outcomes listed below, markers of liver function (Alanine aminotransferase (ALAT), Aspartate Transaminase (ASAT)), HbA1c, sodium, and potassium will be measured in the fasting state on the first morning visit.
The specific objectives are to:
- Assess whether energy intake during an ad libitum meal differs after an acute bout of exercise compared to a rest condition
- Assess whether energy intake during an ad libitum meal after an acute bout of exercise differs between morning and evening
- Assess whether appetite ratings, food reward, and metabolic markers i.e., hormones and metabolites in response to an acute exercise bout and subsequent ad libitum meal differ between morning and evening
- Examine if the above findings differ between individuals with and without T2D
- Identify circulating biomarkers that can be used to stratify individuals with overweight/obesity into primary hedonic or homeostatic driven in terms of ad libitum food intake
- Conditions
- Overweight and Obesity, Type 2 Diabetes
- Being tested
- Exercise, Control
- Keywords
- Overweight, Obesity, Timing, Acute exercise, Circadian rythm, Appetite, Type 2 diabetes, Metabolism
- Medical subject headings
- Overweight, Obesity, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseOther
45 min exercise bout performed on bicycle ergometer. The exercise bout will consist of a 10 min warm-up period at 40 % Watt max followed by 4 cycles of 4 min at 85 % Watt max and 3 min at 50 % Watt max. A cool-down period (7 min) will be performed at 40 % Watt max.
ControlOther
45 min rest during the same time period as the exercise bout on exercise study visits.
| Study group | Role | What they receive |
|---|---|---|
| Morning exercise | Experimental | Study visit performed in the morning with 45 min exercise. Receives: Other: Exercise |
| Morning control | Experimental | Study visit performed in the morning with 45 min rest period. Receives: Other: Control |
| Evening exercise | Experimental | Study visit performed in the evening with 45 min exercise. Receives: Other: Exercise |
| Evening control | Experimental | Study visit performed in the evening with 45 min rest period. Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ad libitum energy intake (KJ) after exercise compared with rest
Food intake (KJ) is measured after meal completion, exercise compared with rest
Measured: Measured after meal consumption at t = 30 minutes
Secondary outcomes (37)
Ad libitum energy intake (KJ) after exercise in the morning compared with evening
Assess whether energy intake during an ad libitum meal after exercise differs between morning and evening
Measured: Measured after meal consumption at t = 30 minutes
Ad libitum energy intake (KJ) after rest in the morning compared with evening
Assess whether energy intake during an ad libitum meal after rest differs between morning and evening
Measured: Measured after meal consumption at t = 30 minutes
Eating pace (KJ/min)
Energy intake relative to duration of meal consumption
Measured: Measured from start to finish of meal consumption at t = 15 minutes to end of meal, morning and evening, exercise and rest
Glucose (mmol/L)
Concentrations of glucose
Measured: Fasting (t = -60 minutes) and at t = 0, 15, 30, 45, 60 minutes, morning and evening, exercise and rest
Triglyceride (mmol/L)
Concentrations of triglyceride
Measured: Fasting (t = -60 minutes) and at t = 0, 15, 30, 45, 60 minutes, morning and evening, exercise and rest
Total cholesterol (mmol/L)
Concentrations of total cholesterol
Measured: Fasting (t = -60 minutes) and at t = 0, 15, 30, 45, 60 minutes, morning and evening, exercise and rest
LDL cholesterol (mmol/L)
Concentrations of LDL cholesterol
Measured: Fasting (t = -60 minutes) and at t = 0, 15, 30, 45, 60 minutes, morning and evening, exercise and rest
HDL cholesterol (mmol/L)
Concentrations of HDL cholesterol
Measured: Fasting (t = -60 minutes) and at t = 0, 15, 30, 45, 60 minutes, morning and evening, exercise and rest
VLDL cholesterol (mmol/L)
Concentrations of VLDL cholesterol
Measured: Fasting (t = -60 minutes) and at t = 0, 15, 30, 45, 60 minutes, morning and evening, exercise and rest
Free-Fatty Acids (mmol/L)
Concentrations of Free-Fatty Acids.
Measured: Fasting (t = -60 minutes) and at t = 0, 15, 30, 45, 60 minutes, morning and evening, exercise and rest
Circulating metabolides (metabolomics) (g/mL)
Concentrations of circulating metabolides measured with metabolomic analysis
Measured: Fasting (t = -60 minutes) and at t = 0, 15, 30, 45, 60 minutes, morning and evening, exercise and rest
Circulating lipids (lipidomics) (g/mL)
Concentrations of circulating lipids measured with lipidomic analysis
Measured: Fasting (t = -60 minutes) and at t = 0, 15, 30, 45, 60 minutes, morning and evening, exercise and rest
Circulating proteins (proteomics) (g/mL)
Concentrations of circulating proteins measured with proteomic analysis
Measured: Fasting (t = -60 minutes) and at t = 0, 15, 30, 45, 60 minutes, morning and evening, exercise and rest
Insulin (pmol/L)
Concentrations of insulin
Measured: Fasting (t = -60 minutes) and at t = 0, 15, 30, 45, 60 minutes, morning and evening, exercise and rest
Glucagon (pmol/L)
Concentrations of glucagon
Measured: Fasting (t = -60 minutes) and at t = 0, 15, 30, 45, 60 minutes, morning and evening, exercise and rest
Total ghrelin (pmol/L)
Concentrations of total ghrelin
Measured: Fasting (t = -60 minutes) and at t = 0, 15, 30, 45, 60 minutes, morning and evening, exercise and rest
Acylated ghrelin (pmol/L)
Concentrations of acylated ghrelin
Measured: Fasting (t = -60 minutes) and at t = 0, 15, 30, 45, 60 minutes, morning and evening, exercise and rest
Glucagon-Like Peptide-1 (GLP-1) (pmol/L)
Concentrations of Glucagon-Like Peptide-1 (GLP-1)
Measured: Fasting (t = -60 minutes) and at t = 0, 15, 30, 45, 60 minutes, morning and evening, exercise and rest
Glucose-Dependent Insulinotropic polypeptide (GIP) (pmol/L)
Concentrations of Glucose-Dependent Insulinotropic polypeptide (GIP)
Measured: Fasting (t = -60 minutes) and at t = 0, 15, 30, 45, 60 minutes, morning and evening, exercise and rest
C-peptide (pmol/L)
Concentrations of C-peptide
Measured: Fasting (t = -60 minutes) and at t = 0, 15, 30, 45, 60 minutes, morning and evening, exercise and rest
Peptide YY (PYY) (pmol/L)
Concentrations of Peptide YY (PYY)
Measured: Fasting (t = -60 minutes) and at t = 0, 15, 30, 45, 60 minutes, morning and evening, exercise and rest
Peptide YY (PYY) 3-36 (pmol/L)
Concentrations of Peptide YY (PYY) 3-36
Measured: Fasting (t = -60 minutes) and at t = 0, 15, 30, 45, 60 minutes, morning and evening, exercise and rest
Fibroblast Growth Factor 21 (FGF-21) (pmol/L)
Concentrations of Fibroblast Growth Factor 21 (FGF-21)
Measured: Fasting (t = -60 minutes) and at t = 0, 15, 30, 45, 60 minutes, morning and evening, exercise and rest
Leptin (pmol/L)
Concentrations of Leptin
Measured: Fasting (t = -60 minutes), and at t = 0, 15, 30, 45, 60 minutes, morning and evening, exercise and rest
Growth Differentiation Factor 15 (GDF-15) (pmol/L)
Concentrations of Growth Differentiation Factor 15 (GDF-15)
Measured: Fasting (t = -60 minutes) and at t = 0, 15, 30, 45, 60 minutes, morning and evening, exercise and rest
Cholecystokinin (CCK) (pmol/L)
Concentrations of Cholecystokinin (CCK)
Measured: Fasting (t = -60 minutes) and at t = 0, 15, 30, 45, 60 minutes, morning and evening, exercise and rest
Pancreatic polypeptide (PP) (pmol/L)
Concentrations of Pancreatic polypeptide (PP)
Measured: Fasting (t = -60 minutes), and at t = 0, 15, 30, 45, 60 minutes, morning and evening, exercise and rest
C-reactive protein (CRP) (pmol(L)
Concentrations of C-reactive protein (CRP)
Measured: Fasting (t = -60 minutes), and at t = 0, 15, 30, 45, 60 minutes, morning and evening, exercise and rest
Food choice
Food choice of food items from four combined food categories (high-fat savoury, high-fat sweet, low-fat savoury and low-fat sweet foods) examined from the SBFPT. Food choice is determined based on frequency of selection made within each food category. The scores range from 0-48 i.e. 0 = foods within a specific food category have not been selected at all to 48 = foods within a specific food category have been selected 48 times.
Measured: Measured before exercise/rest (t = -60 minutes) and after meal consumption (t= 30 minutes), morning and evening, exercise and rest
Attention
Measured using eye tracking in response to looking at food pictures during the computerized Leeds Food Preference Questionnaire.
Includes the following parameters: Gaze: Time spent (ms and %) and revisits (n); and fixations: Time to first fixation (ms), time spent (ms and %), fixation count (n), first fixation duration (ms), average fixation duration (ms). Distance to screen (mm), and gaze direction bias (ratio) which is calculated as the number of trials in which the first fixation was directed to a food image as a proportion to all trials. A bias score ˃0.5 indicates attention towards one food image, a bias score equal to 0.5 indicates no bias, and a bias score <0.5 indicates attention towards the other food images.
Measured: Measured before exercise/rest (t = -60 minutes) and after meal consumption (t= 30 minutes), morning and evening, exercise and rest
Reaction time (ms)
Reaction time during forced food choice of food items from four combined food categories (high-fat savoury, high-fat sweet, low-fat savoury and low-fat sweet foods) examined from the computerized Leeds Food Preference Questionnaire.
Measured: Measured before exercise/rest (t = -60 minutes) and after meal consumption (t= 30 minutes), morning and evening, exercise and rest
Explicit liking
Explicit liking of 16 food items from four combined food categories (high-fat savoury, high-fat sweet, low-fat savoury and low-fat sweet foods) examined from the SBFPT. Explicit liking is rated using visual analogue scales and the range is 0-100. Each end represents the extremes e.g. Question: "how pleasant would it be to taste this food right now?" Answer: "not at all" (rated 0 on the 0-100 scale) to "extremely" (rated 100 on the 0-100 scale).
Measured: Measured before exercise/rest (t = -60 minutes) and after meal consumption (t= 30 minutes), morning and evening, exercise and rest
Implicit wanting
Implicit wanting of food items from four combined food categories (high-fat savoury, high-fat sweet, low-fat savoury and low-fat sweet foods) examined from the SBFPT. Implicit wanting is assessed based on food choice and response time for selected and non-selected food items as well as mean response time (a frequency-weighted algorithm).
In this frequency-weighted algorithm a positive score indicates a more rapid preference for a food type over another food type and a negative score indicates the opposite. A score of zero indicates that food types are equally preferred. The frequency weighted algorithm is used so the implicit wanting score is influenced by both selection (positively contributing to the score) and non-selection (negatively contributing to the score) of food type. Scores for implicit wanting typically range from -100-100 (due to reaction time there is no fixed min-max value)
Measured: Measured before exercise/rest (t = -60 minutes) and after meal consumption (t= 30 minutes), morning and evening, exercise and rest
Explicit wanting
Explicit wanting of 16 food items from four combined food categories (high-fat savoury, high-fat sweet, low-fat savoury and low-fat sweet foods) examined from the SBFPT. Explicit wanting is rated using visual analogue scales and the range is 0-100. Each end represents the extremes e.g. Question: "how much do you want some of this food now?" Answer: "not at all" (rated 0 on the 0-100 scale) to "extremely" (rated 100 on the 0-100 scale).
Measured: Measured before exercise/rest (t = -60 minutes) and after meal consumption (t= 30 minutes), morning and evening, exercise and rest
Subjective appetite
Rated using visual analogue scales and includes sensations of: Hunger, fullness, satiety, prospective food consumption, wellbeing, nausea, thirst, desire to eat meat, salty, and sweet. The scale range is 0-100 and each end represent the extremes e.g. hunger rating: "I am not hungry at all" to "I have never been this hungry before".
Measured: Fasting (t = -60, 0 minutes) and at t = 0, 15, 30, 45, 60 minutes, morning and evening, exercise and rest
Energy intake (KJ)
Assessed from diet records
Measured: Registered 24 hours after the test days, morning and evening, exercise and rest
Borg RPE
Subjective rating of the level of exertion during exercise is collected through the Borg Rating of Percieved Exertion (RPE) at baseline and post exercise, and compared between visits.
Measured: Measured after exercise (t = 0 minutes) , morning and evening
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2023
- Study start22 Mar 2023
- Primary completion21 Aug 2024
- Study completion31 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Overweight and ObesityStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Steno Diabetes Center Copenhagen
- Sponsor type
- University, hospital or other
- Collaborators
- University of Leeds, Novo Nordisk A/S
- Responsible party
- Sponsor
- Investigators
- Kristine Færch, PhD, Principal investigator, Steno Diabetes Center Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05768958
- Sponsor's protocol ID
- H-22019913
- Acronym
- TIMEX
- Status last verified
- Oct 2026
- First submitted
- 15 Feb 2023
- Last updated
- 19 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data from the trial will not be made publicly available as individual data from participants are protected by EU's GDPR (General Data Protection Regulation) laws and Danish Data Protection laws. Study results can be made available upon reasonable request from the corresponding author.
Publications
Launbo NP, Jalking L, Jensen MM, Beaulieu K, Finlayson G, Blond MB, Wiggers A, Rungby J, Nilsson M, Wewer Albrechtsen NJ, Gerstenberg MK, Pedersen HE, Faerch K, Grunnet LG, Salling J. Effects of exercise and exercise timing on energy intake and appetite control: a randomised crossover trial in people with overweight or obesity with and without type 2 diabetes. EBioMedicine. 2026 Jul;129:106353. doi: 10.1016/j.ebiom.2026.106353. Epub 2026 Jul 1.
PubMed 42385612Jalking L, Launbo NP, Jensen MM, Pedersen HE, Blond MB, Gerstenberg MK, Finlayson G, Beaulieu K, Faerch K, Grunnet LG, Quist JS. Effects of exercise and exercise timing on energy intake and appetite control in Danish individuals with overweight or obesity with and without type 2 diabetes: a protocol for a randomised controlled cross-over trial. BMJ Open. 2025 Feb 6;15(2):e092683. doi: 10.1136/bmjopen-2024-092683.
PubMed 39915022
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hedonic and Homeostatic Appetite Control in Obesity and Type 2 Diabetes in the Context of Meal and Exercise Timing
- ClinicalTrials.gov ID
- NCT05768958
- Acronym / sponsor ID
- TIMEX / H-22019913
- Conditions
- Overweight and Obesity, Type 2 Diabetes
- Keywords
- Overweight, Obesity, Timing, Acute exercise, Circadian rythm, Appetite, Type 2 diabetes, Metabolism
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Steno Diabetes Center CopenhagenUniversity, hospital or other
- Collaborators
- University of Leeds, Novo Nordisk A/S
- Study start
- 22 Mar 2023 (actual)
- Primary completion
- 21 Aug 2024 (actual)
- Study completion
- 31 Jul 2026 (actual)
- First posted
- 15 Mar 2023 (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.
The overall aim is to investigate effects of acute exercise on ad libitum energy intake and study whether this differs between morning and evening in individuals with overweight/obesity with or without type 2 diabetes (T2D). Furthermore, the aim is to examine the role of hedonic and homeostatic drivers of appetite control in obesity and T2D in the context of meal and exercise timing.
Detailed description
Fifty-eight adults (age 18 - 75 years old) with overweight/obesity (BMI >25 kg/m2) and with/without T2D will participate in this randomized cross-over study. Participants will complete two visits in the morning and two in the evening with a minimum of 3 days washout. The visits will include ratings of subjective appetite and blood samples in the fasted state followed by either a 45 min exercise bout or rest for the same duration. 15 min after the termination of the exercise bout/rest period the participants will be presented with an ad libitum meal for assessment of energy intake (primary outcome). Then the participants will complete the Steno Biometric Food Preference Task (SBFPT); A computerized task measuring food choice, explicit liking, and implicit and explicit wanting with concomitant biometric measurements. Throughout the visits, subjective appetite will be rated using visual analogue scales and blood will be collected for assessment of appetite-related hormones and metabolites.
(Time: -60 minutes (fasting), -45 minutes (start exercise/rest), 0 minutes (finish exercise/rest), 15 minutes (ad libitum meal), 30 minutes (finish al libitum meal), 60 minutes (end of visit)
Descriptive data will be collected at a visit prior to the test days. These data include body weight (kg), Body Mass Index (BMI, kg/m2), fat mass (kg), fat free mass (kg), fat percentage (%), HbA1c (mmol/mol and %), waist circumference (cm), VO2-0peak and ECG. The participants will furthermore fill in questionnaires regarding the following: Socio-Economic Status (SES), Control Over Eating (CoEQ), Munich Chronotype Questionnaire (MCTQ), Physical Activity Questionnaires (IPAQ), Pittsburgh Sleep Quality Index (PSQI). In addition to the outcomes listed below, markers of liver function (Alanine aminotransferase (ALAT), Aspartate Transaminase (ASAT)), HbA1c, sodium, and potassium will be measured in the fasting state on the first morning visit.
The specific objectives are to:
- Assess whether energy intake during an ad libitum meal differs after an acute bout of exercise compared to a rest condition
- Assess whether energy intake during an ad libitum meal after an acute bout of exercise differs between morning and evening
- Assess whether appetite ratings, food reward, and metabolic markers i.e., hormones and metabolites in response to an acute exercise bout and subsequent ad libitum meal differ between morning and evening
- Examine if the above findings differ between individuals with and without T2D
- Identify circulating biomarkers that can be used to stratify individuals with overweight/obesity into primary hedonic or homeostatic driven in terms of ad libitum food intake
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Morning exercise | Experimental | Other: ExerciseStudy visit performed in the morning with 45 min exercise. |
| Morning control | Experimental | Other: ControlStudy visit performed in the morning with 45 min rest period. |
| Evening exercise | Experimental | Other: ExerciseStudy visit performed in the evening with 45 min exercise. |
| Evening control | Experimental | Other: ControlStudy visit performed in the evening with 45 min rest period. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adults with overweight or obesity (BMI >25 kg/m2) with and without T2D
- HbA1c ≥48 mmol/mol for people with T2D
Key exclusion criteria (15 listed)
- Not able to eat ad libitum meal
- Not able to perform the exercise bout
- Daily smoking
- For women: Pregnancy / planned pregnancy (within the study period) / lactating
- Self-reported history of an eating disorder in the past 3 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise45 min exercise bout performed on bicycle ergometer. The exercise bout will consist of a 10 min warm-up period at 40 % Watt max followed by 4 cycles of 4 min at 85 % Watt max and 3 min at 50 % Watt max. A cool-down period (7 min) will be performed at 40 % Watt max. | Other | Evening exercise, Morning exercise |
| Control45 min rest during the same time period as the exercise bout on exercise study visits. | Other | Evening control, Morning control |
Primary outcome
Ad libitum energy intake (KJ) after exercise compared with rest
Time frame: Measured after meal consumption at t = 30 minutes
Food intake (KJ) is measured after meal completion, exercise compared with rest
37 secondary outcomes
Ad libitum energy intake (KJ) after exercise in the morning compared with evening
Time frame: Measured after meal consumption at t = 30 minutes
Ad libitum energy intake (KJ) after rest in the morning compared with evening
Time frame: Measured after meal consumption at t = 30 minutes
Eating pace (KJ/min)
Time frame: Measured from start to finish of meal consumption at t = 15 minutes to end of meal, morning and evening, exercise and rest
Glucose (mmol/L)
Time frame: Fasting (t = -60 minutes) and at t = 0, 15, 30, 45, 60 minutes, morning and evening, exercise and rest
Triglyceride (mmol/L)
Time frame: Fasting (t = -60 minutes) and at t = 0, 15, 30, 45, 60 minutes, morning and evening, exercise and rest
Total cholesterol (mmol/L)
Time frame: Fasting (t = -60 minutes) and at t = 0, 15, 30, 45, 60 minutes, morning and evening, exercise and rest
LDL cholesterol (mmol/L)
Time frame: Fasting (t = -60 minutes) and at t = 0, 15, 30, 45, 60 minutes, morning and evening, exercise and rest
HDL cholesterol (mmol/L)
Time frame: Fasting (t = -60 minutes) and at t = 0, 15, 30, 45, 60 minutes, morning and evening, exercise and rest
VLDL cholesterol (mmol/L)
Time frame: Fasting (t = -60 minutes) and at t = 0, 15, 30, 45, 60 minutes, morning and evening, exercise and rest
Free-Fatty Acids (mmol/L)
Time frame: Fasting (t = -60 minutes) and at t = 0, 15, 30, 45, 60 minutes, morning and evening, exercise and rest
Circulating metabolides (metabolomics) (g/mL)
Time frame: Fasting (t = -60 minutes) and at t = 0, 15, 30, 45, 60 minutes, morning and evening, exercise and rest
Circulating lipids (lipidomics) (g/mL)
Time frame: Fasting (t = -60 minutes) and at t = 0, 15, 30, 45, 60 minutes, morning and evening, exercise and rest
Circulating proteins (proteomics) (g/mL)
Time frame: Fasting (t = -60 minutes) and at t = 0, 15, 30, 45, 60 minutes, morning and evening, exercise and rest
Insulin (pmol/L)
Time frame: Fasting (t = -60 minutes) and at t = 0, 15, 30, 45, 60 minutes, morning and evening, exercise and rest
Glucagon (pmol/L)
Time frame: Fasting (t = -60 minutes) and at t = 0, 15, 30, 45, 60 minutes, morning and evening, exercise and rest
Total ghrelin (pmol/L)
Time frame: Fasting (t = -60 minutes) and at t = 0, 15, 30, 45, 60 minutes, morning and evening, exercise and rest
Acylated ghrelin (pmol/L)
Time frame: Fasting (t = -60 minutes) and at t = 0, 15, 30, 45, 60 minutes, morning and evening, exercise and rest
Glucagon-Like Peptide-1 (GLP-1) (pmol/L)
Time frame: Fasting (t = -60 minutes) and at t = 0, 15, 30, 45, 60 minutes, morning and evening, exercise and rest
Glucose-Dependent Insulinotropic polypeptide (GIP) (pmol/L)
Time frame: Fasting (t = -60 minutes) and at t = 0, 15, 30, 45, 60 minutes, morning and evening, exercise and rest
C-peptide (pmol/L)
Time frame: Fasting (t = -60 minutes) and at t = 0, 15, 30, 45, 60 minutes, morning and evening, exercise and rest
Peptide YY (PYY) (pmol/L)
Time frame: Fasting (t = -60 minutes) and at t = 0, 15, 30, 45, 60 minutes, morning and evening, exercise and rest
Peptide YY (PYY) 3-36 (pmol/L)
Time frame: Fasting (t = -60 minutes) and at t = 0, 15, 30, 45, 60 minutes, morning and evening, exercise and rest
Fibroblast Growth Factor 21 (FGF-21) (pmol/L)
Time frame: Fasting (t = -60 minutes) and at t = 0, 15, 30, 45, 60 minutes, morning and evening, exercise and rest
Leptin (pmol/L)
Time frame: Fasting (t = -60 minutes), and at t = 0, 15, 30, 45, 60 minutes, morning and evening, exercise and rest
Growth Differentiation Factor 15 (GDF-15) (pmol/L)
Time frame: Fasting (t = -60 minutes) and at t = 0, 15, 30, 45, 60 minutes, morning and evening, exercise and rest
Cholecystokinin (CCK) (pmol/L)
Time frame: Fasting (t = -60 minutes) and at t = 0, 15, 30, 45, 60 minutes, morning and evening, exercise and rest
Pancreatic polypeptide (PP) (pmol/L)
Time frame: Fasting (t = -60 minutes), and at t = 0, 15, 30, 45, 60 minutes, morning and evening, exercise and rest
C-reactive protein (CRP) (pmol(L)
Time frame: Fasting (t = -60 minutes), and at t = 0, 15, 30, 45, 60 minutes, morning and evening, exercise and rest
Food choice
Time frame: Measured before exercise/rest (t = -60 minutes) and after meal consumption (t= 30 minutes), morning and evening, exercise and rest
Attention
Time frame: Measured before exercise/rest (t = -60 minutes) and after meal consumption (t= 30 minutes), morning and evening, exercise and rest
Reaction time (ms)
Time frame: Measured before exercise/rest (t = -60 minutes) and after meal consumption (t= 30 minutes), morning and evening, exercise and rest
Explicit liking
Time frame: Measured before exercise/rest (t = -60 minutes) and after meal consumption (t= 30 minutes), morning and evening, exercise and rest
Implicit wanting
Time frame: Measured before exercise/rest (t = -60 minutes) and after meal consumption (t= 30 minutes), morning and evening, exercise and rest
Explicit wanting
Time frame: Measured before exercise/rest (t = -60 minutes) and after meal consumption (t= 30 minutes), morning and evening, exercise and rest
Subjective appetite
Time frame: Fasting (t = -60, 0 minutes) and at t = 0, 15, 30, 45, 60 minutes, morning and evening, exercise and rest
Energy intake (KJ)
Time frame: Registered 24 hours after the test days, morning and evening, exercise and rest
Borg RPE
Time frame: Measured after exercise (t = 0 minutes) , morning and evening
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2026.
- Derived from this study: PubMed 42385612Launbo NP, Jalking L, Jensen MM, Beaulieu K, Finlayson G, Blond MB, Wiggers A, Rungby J, Nilsson M, Wewer Albrechtsen NJ, Gerstenberg MK, Pedersen HE, Faerch K, Grunnet LG, Salling J. Effects of exercise and exercise timing on energy intake and appetite control: a randomised crossover trial in people with overweight or obesity with and without type 2 diabetes. EBioMedicine. 2026 Jul;129:106353. doi: 10.1016/j.ebiom.2026.106353. Epub 2026 Jul 1.
- Derived from this study: PubMed 39915022Jalking L, Launbo NP, Jensen MM, Pedersen HE, Blond MB, Gerstenberg MK, Finlayson G, Beaulieu K, Faerch K, Grunnet LG, Quist JS. Effects of exercise and exercise timing on energy intake and appetite control in Danish individuals with overweight or obesity with and without type 2 diabetes: a protocol for a randomised controlled cross-over trial. BMJ Open. 2025 Feb 6;15(2):e092683. doi: 10.1136/bmjopen-2024-092683.
- Individual participant dataSharing planned: Yes. Data from the trial will not be made publicly available as individual data from participants are protected by EU's GDPR (General Data Protection Regulation) laws and Danish Data Protection laws. Study results can be made available upon reasonable request from the corresponding author.
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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. This study is not recruiting at the moment.
Kristine Færch, PhD principal investigator
Steno Diabetes Center Copenhagen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise in people with Overweight and Obesity and Type 2 Diabetes, run by Steno Diabetes Center Copenhagen at 1 site in Denmark.
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 15 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: finished, as of the sponsor's last update on 19 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 Denmark. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ad libitum energy intake (KJ) after exercise compared with rest (time frame: Measured after meal consumption at t = 30 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05768958, which also lists 2 linked publications.
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 19 Oct 2026.