Effects of a High-protein Diet and Resistance Training on Fat-mass Loss Maintenance (PRO-FIT)

Norwegian University of Science and Technology

Status: Active, not recruiting

Conditions: Obesity (Body Mass Index >30 kg/m2)

Treatments: Other: Balanced control diet; Other: High-protein diet and resistance training

Study type: Interventional

Funder types: Other

Identifiers

NCT07113561

592611

Details and patient eligibility

About

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. 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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
• 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 design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

60 participants in 2 patient groups

High-protein diet and resistance training

Experimental group

Description:

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.

Treatment:

Other: High-protein diet and resistance training

Balanced control diet

Experimental group

Description:

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.

Treatment:

Other: Balanced control diet