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| Name | Class |
|---|---|
| University of Leeds | OTHER |
| Novo Nordisk A/S | INDUSTRY |
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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.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Morning exercise | Experimental | Study visit performed in the morning with 45 min exercise. |
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| Morning control | Experimental | Study visit performed in the morning with 45 min rest period. |
|
| Evening exercise | Experimental | Study visit performed in the evening with 45 min exercise. |
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| Evening control | Experimental | Study visit performed in the evening with 45 min rest period. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exercise | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Ad libitum energy intake (KJ) after exercise compared with rest | Food intake (KJ) is measured after meal completion, exercise compared with rest | Measured after meal consumption at t = 30 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| 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 after meal consumption at t = 30 minutes |
| Ad libitum energy intake (KJ) after rest in the morning compared with evening |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kristine Færch, PhD | Steno Diabetes Center Copenhagen | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Steno Diabetes Center Copenhagen | Herlev | DK-2730 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42385612 | Derived | 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 1;129:106353. doi: 10.1016/j.ebiom.2026.106353. Online ahead of print. | |
| 39915022 |
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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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| ID | Term |
|---|---|
| D050177 | Overweight |
| D009765 | Obesity |
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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| ID | Term |
|---|---|
| D015444 | Exercise |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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|
| Control | Other | 45 min rest during the same time period as the exercise bout on exercise study visits. |
|
Assess whether energy intake during an ad libitum meal after rest differs between morning and evening |
| Measured after meal consumption at t = 30 minutes |
| Eating pace (KJ/min) | Energy intake relative to duration of meal consumption | 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 | 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 | 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 | 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 | 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 | 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 | 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. | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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) | 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) | 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 | 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) | 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 | 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) | 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 | 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) | 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) | 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) | 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) | 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 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 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 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 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 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 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". | 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 | 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 after exercise (t = 0 minutes) , morning and evening |
| Derived |
| Jalking 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. |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D004700 | Endocrine System Diseases |