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

NCT07113561 | Active Not Recruiting

• 1 other identifier: 592611
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Conditions

Obesity (Body Mass Index >30 kg/m2)

Outcome Measures

Primary Outcomes (2)

• 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.

Secondary Outcomes (34)

• Body weight and -composition

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

• Anthropometric variables

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

• Resting metabolic rate

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

• Leeds food preference questionnaire

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

• Dutch Eating Behavior Questionnaire

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

Other Outcomes (5)

• Food records

  Before start of intervention, during weight loss phase, at 6 month follow up, and prior to assessments at week 52.

• Ketone bodies

  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

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

Study Arms (2)

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.

Other: High-protein diet and resistance training

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.

Other: Balanced control diet

Interventions

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.

High-protein diet and resistance training

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.

Balanced control diet

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Norwegian University of Science and Technology: lead
• University of Alabama at Birmingham: collaborator
• University of Leeds, Appetite Control and Energy Balance Research: collaborator
• University of Copenhagen: collaborator
• St. Olavs Hospital: collaborator

Study Sites (1)

Norwegian University of Science and Technology

Trondheim, Norway

Location

MeSH Terms

Conditions

Obesity

Interventions

Diet, High-Protein; Resistance Training

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Physical Therapy Modalities; Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2025
• First Posted: August 8, 2025
• Study Start: September 16, 2025
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: January 30, 2026

Record last verified: 2026-01

Locations

NO (1)