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Obesity (Body Mass Index >30 kg/m2)PRO-FITNCT07113561

Effects of a High-protein Diet and Resistance Training on Fat-mass Loss Maintenance

A study testing High-protein diet and resistance training in people with Obesity (Body Mass Index >30 kg/m2), run by Norwegian University of Science and Technology at 1 site in Norway.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

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: 1. Read more about this study

Who is it for?
Ages 18 to 50 years
Conditions the study is for
Obesity (Body Mass Index >30 kg/m2)
What is being tested?
High-protein diet and resistance training
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteNorway
Study dates
16 Sep 2025to Dec 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

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 50 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • BMI equal to or above 30
  • Sedentary lifestyle (<150 minutes moderate physical activity per week and no habitual resistance training (< once weekly)
  • < 2 kg body weight change in the 3 months prior to study commencement
  • high motivation for lifestyle change
  • not currently enrolled in any other obesity or behavioral change program

Who cannot join

  • Previous or planned bariatric surgery
  • Current or planned usage of medications or anti-obesity drugs known to influence energy metabolism or appetite
  • Diabetes (type 1 and 2)
  • Women in menopause or post-menopausal women
  • Existing cancer diagnosis
  • Renal disease
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  • Substance abuse
  • Eating disorders
  • Allergies, or intolerances to ingredients in meal packs/supplements intended for use in the study
  • Mobility/physical constrains or musculoskeletal issues that could impede participation in the resistance training program

Trial locations and contacts

1 site in 1 country.

Norway1 site
  • Norwegian University of Science and Technology

    Trondheim

Other trials in Norway

About this study

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:

Read more
  1. A control group receiving a balanced low-calorie diet.
  2. An intervention group receiving a high-protein, low-calorie diet and supervised resistance training.

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.

Being tested
High-protein diet and resistance training, Balanced control diet
Medical subject headings
Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • High-protein diet and resistance trainingOther

    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.

  • Balanced control dietOther

    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.

Study groups in NCT07113561
Study groupRoleWhat they receive
High-protein diet and resistance trainingExperimentalIntervention 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.
Receives: Other: High-protein diet and resistance training
Balanced control dietExperimentalControl 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.
Receives: Other: Balanced control diet

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Fat-mass

    Fat-mass will be estimated using a dual-energy absorptiometry (DXA, GE Healthcare Lunar).

    Measured: From enrollment at baseline , after 10 weeks of weight loss phase, and at 52 weeks.

Secondary outcomes (33)
  1. 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.

    Measured: From enrollment at baseline , after 10 weeks of weight loss phase, 26 and at 52 weeks.

  2. Resting metabolic rate

    Resting metabolic rate will be measured in the fasted state using an indirect calorimetry (Quark RMR, Cosmed).

    Measured: From enrollment at baseline , after 10 weeks of weight loss phase, and at 52 weeks.

  3. 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.

    Measured: From enrollment at baseline , after 10 weeks of weight loss phase, and at 52 weeks.

  4. 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.

    Measured: From enrollment at baseline , after 10 weeks of weight loss phase, and at 26 and 52 weeks.

  5. 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.

    Measured: From enrollment at baseline , after 10 weeks of weight loss phase, and at 26 and 52 weeks.

  6. 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.

    Measured: From enrollment at baseline , after 10 weeks of weight loss phase, and at 26 and 52 weeks.

  7. 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.

    Measured: From enrollment at baseline , after 10 weeks of weight loss phase, and at 52 weeks.

  8. 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.

    Measured: From enrollment at baseline , after 10 weeks of weight loss phase, and at 52 weeks.

  9. 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.

    Measured: From enrollment at baseline , after 10 weeks of weight loss phase, and at 52 weeks.

  10. 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.

    Measured: From enrollment at baseline , after 10 weeks of weight loss phase, and at 52 weeks.

  11. 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.

    Measured: From enrollment at baseline , after 10 weeks of weight loss phase, and at 52 weeks.

  12. 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.

    Measured: From enrollment at baseline , after 10 weeks of weight loss phase, and at 52 weeks.

  13. 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.

    Measured: From enrollment at baseline , after 10 weeks of weight loss phase, and at 52 weeks.

  14. 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.

    Measured: From enrollment at baseline , after 10 weeks of weight loss phase, and at 52 weeks.

  15. 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.

    Measured: From enrollment at baseline , after 10 weeks of weight loss phase, and at 52 weeks.

  16. IL-6

    Blood will be collected and plasma samples will be stored and analyzed for IL-6 concentrations depending on additional funding.

    Measured: From enrollment at baseline , after 10 weeks of weight loss phase, and at 52 weeks.

  17. TNF-alfa

    Blood will be collected and plasma samples will be stored and analyzed for TNF-alfa concentrations depending on additional funding.

    Measured: From enrollment at baseline , after 10 weeks of weight loss phase, and at 52 weeks.

  18. CRP

    Blood will be collected in the fasted state (minute 0), and analyzed for CRP.

    Measured: From enrollment at baseline , after 10 weeks of weight loss phase, and at 52 weeks.

  19. Triglycerides

    Blood will be collected in the fasted state (minute 0), and analyzed for triglycerides.

    Measured: From enrollment at baseline , after 10 weeks of weight loss phase, and at 52 weeks.

  20. HbA1C

    Blood will be collected in the fasted state (minute 0), and analyzed for HbA1C

    Measured: From enrollment at baseline , after 10 weeks of weight loss phase, and at 52 weeks.

  21. HDL

    Blood will be collected in the fasted state (minute 0), and analyzed for high-density lipoprotein

    Measured: From enrollment at baseline , after 10 weeks of weight loss phase, and at 52 weeks.

  22. LDL

    Blood will be collected in the fasted state (minute 0), and analyzed for low-density lipoprotein

    Measured: From enrollment at baseline , after 10 weeks of weight loss phase, and at 52 weeks.

  23. Total cholesterol

    Blood will be collected in the fasted state (minute 0), and analyzed for total choesterol.

    Measured: From enrollment at baseline , after 10 weeks of weight loss phase, and at 52 weeks.

  24. Hemoglobin

    Blood will be collected in the fasted state (minute 0), and analyzed for hemoglobin.

    Measured: From enrollment at baseline , after 10 weeks of weight loss phase, and at 52 weeks.

  25. Gut microbiota

    Fecal samples will be collected and comprehensive microbiota profiling using DNA-based sequencing will be performed.

    Measured: From enrollment at baseline , after 10 weeks of weight loss phase, and at 52 weeks.

  26. Short-chain fatty-acids

    Fecal samples will be collected and acetate, propionate, and butyrate will be quantified by gas chromatography-mass spectrometry (GC-MS)

    Measured: From enrollment at baseline , after 10 weeks of weight loss phase, and at 52 weeks.

  27. 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.

    Measured: From enrollment at baseline , after 10 weeks of weight loss phase, and at 52 weeks.

  28. 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.

    Measured: From enrollment at baseline , after 10 weeks of weight loss phase, and at 52 weeks.

  29. Estimated one-repetition maximum (1RM)

    1RM will be calculated using submaximal lifts performed to muscular failure within 4-8 repetitions.

    Measured: From enrollment at baseline , after 10 weeks of weight loss phase, and at 26- and 52 weeks.

  30. 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.

    Measured: From enrollment at baseline , after 10 weeks of weight loss phase, and at 52 weeks.

  31. 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.

    Measured: From enrollment at baseline , after 10 weeks of weight loss phase, and at 52 weeks.

  32. 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.

    Measured: From enrollment at baseline , after 10 weeks of weight loss phase, and at 52 weeks.

  33. Blood pressure

    Blood pressure will be measured in units of millimeters of mercury (mmHg)

    Measured: From enrollment at baseline , after 10 weeks of weight loss phase, and at 52 weeks.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Aug 2025
  2. Study start16 Sep 2025
  3. Primary completionJan 2027 (estimated)
  4. Study completionDec 2027 (estimated)

Resources

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
Parallel groups
Masking
None (open label)
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07113561
Sponsor's protocol ID
592611
Acronym
PRO-FIT
Status last verified
Oct 2026
First submitted
8 Jul 2025
Last updated
23 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Participant-level data will not be made publicly available due to the sensitive nature of the health-related and biological data collected. Data may be shared with approved collaborators for analyses within the scope of the project, subject to applicable ethical approvals, participant consent, institutional procedures, and data-sharing agreements. Any use beyond the approved project scope will require additional approvals and, where applicable, new participant consent.

Questions about this trial

What is this clinical trial studying?

A study testing High-protein diet and resistance training in people with Obesity (Body Mass Index &gt;30 kg/m2), run by Norwegian University of Science and Technology at 1 site in Norway.

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 5 inclusion and 10 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: under way, not looking for participants, as of the sponsor's last update on 23 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 Norway. 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?

This study is still under way. Results are not available in the source record yet.

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?

Fat-mass (time frame: From enrollment at baseline , after 10 weeks of weight loss phase, and at 52 weeks.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 23 Oct 2026.

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