Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| University of Alabama at Birmingham | OTHER |
| University of Leeds, Appetite Control and Energy Balance Research | UNKNOWN |
| University of Copenhagen | OTHER |
Not provided
Not provided
Not provided
Not provided
This clinical trial investigates whether a high-protein diet combined with resistance training is more effective than a standard low-calorie diet for maintaining fat mass loss in individuals with obesity.
A total of 60 adults with obesity (BMI ≥30 kg/m²) will be randomly assigned at baseline to one of two groups:
All participants will follow their assigned low-energy diets for the first 10 weeks, which constitutes the weight loss phase. The subsequent 42 weeks comprise the weight maintenance phase, where participants will follow an energy-balanced diet adapted to their individual needs and continue in their assigned group.
The intervention group will also complete supervised resistance training three times per week during the first 10 weeks, with continued follow-up throughout the maintenance phase.
Assessments will take place at baseline, week 11, 6 months, and 12 months, and include measurements of fat and lean mass, resting metabolic rate, appetite hormones, glucose metabolism, inflammation, gut microbiota and its metabolites, hedonic appetite, eating behavior, and quality of life and physical function. Participants will also provide food intake records, physical activity dat.
The primary aim is to determine whether the combined high-protein diet and resistance training intervention results in greater long-term fat mass loss and muscle mass preservation than the control diet. Secondary aims include effects on appetite regulation, eating behavior, metabolic health, and patient-reported outcomes.
The study is conducted at NTNU and St. Olavs Hospital in Trondheim, Norway, and registered under the acronym PRO-FIT.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High-protein diet and resistance training | Experimental | Intervention group: Participants will undergo a low-calorie high-protein diet for 10 weeks, followed by a maintenance phase up to the 1-year mark. This group will also participate in supervised resistance training sessions. |
|
| Balanced control diet | Experimental | Control group: Participants will undergo a balanced low-calorie diet for 10 weeks, followed by a maintenance phase up to the 1-year mark. This group will not receive any active exercise intervention. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| High-protein diet and resistance training | Other | Participants will consume a low-energy high-protein diet for 10 weeks, and participate in supervised resistance training sessions. They will continue a maintenance diet up until the 1 year mark, with bi-monthly follow ups on diet and exercise. |
| Measure | Description | Time Frame |
|---|---|---|
| Fat-mass | Fat-mass will be estimated using a dual-energy absorptiometry (DXA, GE Healthcare Lunar). | From enrollment at baseline , after 10 weeks of weight loss phase, and at 52 weeks. |
| Fat-free mass | Fat-free mass will be estimated using a dual-energy absorptiometry (DXA, GE Healthcare Lunar). | From enrollment at baseline , after 10 weeks of weight loss phase, and at 52 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Body weight and -composition | Body weight and -composition will be estimated with dual-energy absorptiometry (DXA, GE Healthcare Lunar) (primary outcomes) and bioimpedance (InBody 770). Compartments that will be estimated are: total body weight, Fat-mass, fat-free mass, bone mineral density, visceral fat, muscle mass, body water, as well as segmental analysis of body weight and composition. | From enrollment at baseline , after 10 weeks of weight loss phase, 26 and at 52 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Food records | Participants will quantify their daily energy intake by logging self-reported food diaries. Energy intake and macronutrient distribution will be calculated based on reported foods and quantitates. | Before start of intervention, during weight loss phase, at 6 month follow up, and prior to assessments at week 52. |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Norwegian University of Science and Technology | Trondheim | Norway |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000073600 | Diet, High-Protein |
| D055070 | Resistance Training |
| ID | Term |
|---|---|
| D004035 | Diet Therapy |
| D044623 | Nutrition Therapy |
| D013812 | Therapeutics |
| D004032 | Diet |
| D009747 |
Not provided
Not provided
| St. Olavs Hospital |
| OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Balanced control diet | Other | Participants will consume a balanced low-energy diet for 10 weeks, and continue a balanced maintenance diet with bi-monthly follow ups up until the 1-year mark No active exercise intervention. |
|
| Anthropometric variables | Height, hip- and waist circumference will be measured using standardized methods. Body weight and height will be used to calculate body mass index in kg/m^2. Hip-, waist- and height measurements will be used to calculate height/waist- and hip/waist ratio. | From enrollment at baseline , after 10 weeks of weight loss phase, 26 and at 52 weeks. |
| Resting metabolic rate | Resting metabolic rate will be measured in the fasted state using an indirect calorimetry (Quark RMR, Cosmed). | From enrollment at baseline , after 10 weeks of weight loss phase, and at 52 weeks. |
| Leeds food preference questionnaire | Food reward and -preferences will be assessed with the Leeds Food Preference Questionnaire (LFPQ), in the fasted state and immediately after the test meal. The LFPQ is a computerized behavioral task that provides measures of 'explicit liking' and explicit and 'implicit wanting' for sensory and nutrient dimensions of foods using food images. | From enrollment at baseline , after 10 weeks of weight loss phase, and at 52 weeks. |
| Dutch Eating Behavior Questionnaire | The Dutch Eating Behavior Questionnaire measures restrained, external and emotional eating. Emotional eating can be divided into two sub-categories: diffuse emotions and clearly labelled emotions. The greater score, the greater external/emotional eating. | From enrollment at baseline , after 10 weeks of weight loss phase, and at 26 and 52 weeks. |
| Power of Food Scale | The Power of food scale is a psychometric evaluation that measures an individual's preoccupation with wanting of highly palatable foods. The PFS consists of a 15-item list that measures hedonic hunger (food-related thoughts that are unrelated to homeostatic need). The higher the PFS score, the greater the hedonic hunger. | From enrollment at baseline , after 10 weeks of weight loss phase, and at 26 and 52 weeks. |
| Three Factor Eating Questionnaire | The Three Factor Eating Questionnaire measures three different dimensions: restraint, disinhibition, and hunger. The greater score, the stronger is the trait/behavior. | From enrollment at baseline , after 10 weeks of weight loss phase, and at 26 and 52 weeks. |
| Ghrelin | Blood will be collected in the fasted state (minute 0), and then at intervals after a standardized breakfast (minute 15, 30, 45, 60, 90, 120 and 150) and analyzed for acylated ghrelin concentrations. | From enrollment at baseline , after 10 weeks of weight loss phase, and at 52 weeks. |
| GLP-1 | Blood will be collected in the fasted state (minute 0), and then at intervals after a standardized breakfast (minute 15, 30, 45, 60, 90, 120 and 150) and analyzed for total GLP-1 concentrations. | From enrollment at baseline , after 10 weeks of weight loss phase, and at 52 weeks. |
| CCK | Blood will be collected in the fasted state (minute 0), and then at intervals after a standardized breakfast (minute 15, 30, 45, 60, 90, 120 and 150) and analyzed for CCK concentrations. | From enrollment at baseline , after 10 weeks of weight loss phase, and at 52 weeks. |
| PYY | Blood will be collected in the fasted state (minute 0), and then at intervals after a standardized breakfast (minute 15, 30, 45, 60, 90, 120 and 150) and analyzed for total PYY concentrations. | From enrollment at baseline , after 10 weeks of weight loss phase, and at 52 weeks. |
| Insulin | Blood will be collected in the fasted state (minute 0), and then at intervals after a standardized breakfast (minute 15, 30, 45, 60, 90, 120 and 150) and analyzed for insulin concentrations. | From enrollment at baseline , after 10 weeks of weight loss phase, and at 52 weeks. |
| C-peptide | Blood will be collected in the fasted state (minute 0), and then at intervals after a standardized breakfast (minute 15, 30, 45, 60, 90, 120 and 150) and analyzed for c-peptide concentrations. | From enrollment at baseline , after 10 weeks of weight loss phase, and at 52 weeks. |
| Glucose | Blood will be collected in the fasted state (minute 0), and then at intervals after a standardized breakfast (minute 15, 30, 45, 60, 90, 120 and 150) and analyzed for glucose concentrations. | From enrollment at baseline , after 10 weeks of weight loss phase, and at 52 weeks. |
| GIP | Blood will be collected in the fasted state (minute 0), and then at intervals after a standardized breakfast (minute 15, 30, 45, 60, 90, 120 and 150). Plasma samples will be stored and analyzed for GIP concentrations depending on additional funding. | From enrollment at baseline , after 10 weeks of weight loss phase, and at 52 weeks. |
| Glucagon | Blood will be collected in the fasted state (minute 0), and then at intervals after a standardized breakfast (minute 15, 30, 45, 60, 90, 120 and 150). Plasma samples will be stored and analyzed for glucagon concentrations depending on additional funding. | From enrollment at baseline , after 10 weeks of weight loss phase, and at 52 weeks. |
| IL-6 | Blood will be collected and plasma samples will be stored and analyzed for IL-6 concentrations depending on additional funding. | From enrollment at baseline , after 10 weeks of weight loss phase, and at 52 weeks. |
| TNF-alfa | Blood will be collected and plasma samples will be stored and analyzed for TNF-alfa concentrations depending on additional funding. | From enrollment at baseline , after 10 weeks of weight loss phase, and at 52 weeks. |
| CRP | Blood will be collected in the fasted state (minute 0), and analyzed for CRP. | From enrollment at baseline , after 10 weeks of weight loss phase, and at 52 weeks. |
| Triglycerides | Blood will be collected in the fasted state (minute 0), and analyzed for triglycerides. | From enrollment at baseline , after 10 weeks of weight loss phase, and at 52 weeks. |
| HbA1C | Blood will be collected in the fasted state (minute 0), and analyzed for HbA1C | From enrollment at baseline , after 10 weeks of weight loss phase, and at 52 weeks. |
| HDL | Blood will be collected in the fasted state (minute 0), and analyzed for high-density lipoprotein | From enrollment at baseline , after 10 weeks of weight loss phase, and at 52 weeks. |
| LDL | Blood will be collected in the fasted state (minute 0), and analyzed for low-density lipoprotein | From enrollment at baseline , after 10 weeks of weight loss phase, and at 52 weeks. |
| Total cholesterol | Blood will be collected in the fasted state (minute 0), and analyzed for total choesterol. | From enrollment at baseline , after 10 weeks of weight loss phase, and at 52 weeks. |
| Hemoglobin | Blood will be collected in the fasted state (minute 0), and analyzed for hemoglobin. | From enrollment at baseline , after 10 weeks of weight loss phase, and at 52 weeks. |
| Gut microbiota | Fecal samples will be collected and comprehensive microbiota profiling using DNA-based sequencing will be performed. | From enrollment at baseline , after 10 weeks of weight loss phase, and at 52 weeks. |
| Short-chain fatty-acids | Fecal samples will be collected and acetate, propionate, and butyrate will be quantified by gas chromatography-mass spectrometry (GC-MS) | From enrollment at baseline , after 10 weeks of weight loss phase, and at 52 weeks. |
| IWQOL-lite | The Impact of Weight on Quality of Life (IWQOL)-Lite questionnaire will be used to assess obesity-specific quality of life and includes 5 subcategories: physical function, self-compassion, sexual life, public distress and work. In addition, the total quality of life score will be assessed. Higher score, better quality of life. | From enrollment at baseline , after 10 weeks of weight loss phase, and at 52 weeks. |
| Short Form-36 (SF-36) | The SF-36, or Short Form 36, is a 36-item questionnaire used to assess a person's self-reported health-related quality of life. It measures eight health concepts: physical functioning, role limitations due to physical health, bodily pain, general health, vitality, social functioning, role limitations due to emotional health, and mental health where a higher score represents better health. | From enrollment at baseline , after 10 weeks of weight loss phase, and at 52 weeks. |
| Estimated one-repetition maximum (1RM) | 1RM will be calculated using submaximal lifts performed to muscular failure within 4-8 repetitions. | From enrollment at baseline , after 10 weeks of weight loss phase, and at 26- and 52 weeks. |
| Patient specific functional Scale | The Patient Specific Functional Scale is a patient-specific instrument. This means that the patient selects activities (three to five) that they have difficulty performing due to their illness or injury, and then rates their ability to perform these activities. | From enrollment at baseline , after 10 weeks of weight loss phase, and at 52 weeks. |
| Force development- and peak force | A one-repetition max tests and a force development- and peak force task will be undertaken on a force platform (Kistler, Switzerland) installed on a leg press device. | From enrollment at baseline , after 10 weeks of weight loss phase, and at 52 weeks. |
| Subjective appetite | Subjective ratings of appetite (hunger, fullness, desire to eat, and prospective food consumption) will be measured in fasting (minute 0) and then at minute 15, 30, 60, 90, 120 and 150 after the standardized test meal. | From enrollment at baseline , after 10 weeks of weight loss phase, and at 52 weeks. |
| Blood pressure | Blood pressure will be measured in units of millimeters of mercury (mmHg) | From enrollment at baseline , after 10 weeks of weight loss phase, and at 52 weeks. |
| Ketone bodies |
In addition to food logs, ketone bodies will be measured for compliance to diet and to account for potential nutritional induced ketosis. Acetoacetate will be measured in urine using Bayer ketostix and betahydroxtbutyrate using a freestyle libre ketone meter. |
| At baseline assessments, during weight loss phase( baseline to week 11), at week 11 assessments, at 6 months and assessments at week 52 |
| Plasma samples | Plasma samples will also be stored for exploratory analyses later | From enrollment at baseline , after 10 weeks of weight loss phase, and at 52 weeks. |
| Adherence to exercise intervention | Attendance to scheduled training sessions will be recorded, together with type of exercise, sets, reps and loads. | During weight loss phase( baseline to week 11), and during maintenance phase up until week 52 |
| Physical activity levels | Physical activity levels will be estimated using actigraphs for 7-day periods. | Before and during weight loss phase( baseline to week 11), at 26 and 52 weeks |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D005081 | Exercise Therapy |
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
| D005791 | Patient Care |
| D026741 | Physical Therapy Modalities |
| D064797 | Physical Conditioning, Human |
| D015444 | Exercise |
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |