Effects of a High-protein Diet and Resistance Training on Fat-mass Loss Maintenance
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Fat-mass
Study Overview
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:
- A control group receiving a balanced low-calorie diet.
- 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 50 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
High-protein diet and resistance training
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.
Intervention: High-protein diet and resistance training (Other)
Balanced control diet
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.
Intervention: Balanced control diet (Other)
Outcomes
Primary Outcomes
Fat-mass
Time Frame: From enrollment at baseline , after 10 weeks of weight loss phase, and at 52 weeks.
Fat-mass will be estimated using a dual-energy absorptiometry (DXA, GE Healthcare Lunar).
Fat-free mass
Time Frame: From enrollment at baseline , after 10 weeks of weight loss phase, and at 52 weeks.
Fat-free mass will be estimated using a dual-energy absorptiometry (DXA, GE Healthcare Lunar).
Secondary Outcomes
- Glucose(From enrollment at baseline , after 10 weeks of weight loss phase, and at 52 weeks.)
- 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.)
- Power of Food Scale(From enrollment at baseline , after 10 weeks of weight loss phase, and at 26 and 52 weeks.)
- Three Factor Eating Questionnaire(From enrollment at baseline , after 10 weeks of weight loss phase, and at 26 and 52 weeks.)
- Ghrelin(From enrollment at baseline , after 10 weeks of weight loss phase, and at 52 weeks.)
- GLP-1(From enrollment at baseline , after 10 weeks of weight loss phase, and at 52 weeks.)
- CCK(From enrollment at baseline , after 10 weeks of weight loss phase, and at 52 weeks.)
- PYY(From enrollment at baseline , after 10 weeks of weight loss phase, and at 52 weeks.)
- Insulin(From enrollment at baseline , after 10 weeks of weight loss phase, and at 52 weeks.)
- C-peptide(From enrollment at baseline , after 10 weeks of weight loss phase, and at 52 weeks.)
- GIP(From enrollment at baseline , after 10 weeks of weight loss phase, and at 52 weeks.)
- Glucagon(From enrollment at baseline , after 10 weeks of weight loss phase, and at 52 weeks.)
- IL-6(From enrollment at baseline , after 10 weeks of weight loss phase, and at 52 weeks.)
- TNF-alfa(From enrollment at baseline , after 10 weeks of weight loss phase, and at 52 weeks.)
- CRP(From enrollment at baseline , after 10 weeks of weight loss phase, and at 52 weeks.)
- Triglycerides(From enrollment at baseline , after 10 weeks of weight loss phase, and at 52 weeks.)
- HbA1C(From enrollment at baseline , after 10 weeks of weight loss phase, and at 52 weeks.)
- HDL(From enrollment at baseline , after 10 weeks of weight loss phase, and at 52 weeks.)
- LDL(From enrollment at baseline , after 10 weeks of weight loss phase, and at 52 weeks.)
- Total cholesterol(From enrollment at baseline , after 10 weeks of weight loss phase, and at 52 weeks.)
- Hemoglobin(From enrollment at baseline , after 10 weeks of weight loss phase, and at 52 weeks.)
- Gut microbiota(From enrollment at baseline , after 10 weeks of weight loss phase, and at 52 weeks.)
- Short-chain fatty-acids(From enrollment at baseline , after 10 weeks of weight loss phase, and at 52 weeks.)
- IWQOL-lite(From enrollment at baseline , after 10 weeks of weight loss phase, and at 52 weeks.)
- Short Form-36 (SF-36)(From enrollment at baseline , after 10 weeks of weight loss phase, and at 52 weeks.)
- Estimated one-repetition maximum (1RM)(From enrollment at baseline , after 10 weeks of weight loss phase, and at 26- and 52 weeks.)
- Patient specific functional Scale(From enrollment at baseline , after 10 weeks of weight loss phase, and at 52 weeks.)
- Force development- and peak force(From enrollment at baseline , after 10 weeks of weight loss phase, and at 52 weeks.)
- Subjective appetite(From enrollment at baseline , after 10 weeks of weight loss phase, and at 52 weeks.)
- Blood pressure(From enrollment at baseline , after 10 weeks of weight loss phase, and at 52 weeks.)