High-intensity Interval Training Versus Moderate Intensity Continuous Training on Gut Microbiota in Non-alcoholic Fatty Liver

NCT07697313 | Not Yet Recruiting

• 1 other identifier: Heba-Phd
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

To compare High-Intensity Interval Training versus moderate intensity continuous training on gut microbiota in Non- Alcoholic Fatty Liver.

Conditions

Non-alcoholic Fatty Liver

Outcome Measures

Primary Outcomes (2)

• assessment of short chain free fatty acids butyrate and acetate

  For short chain free fatty acids analyses, fecal sample will be separated. Applying four analytes, including total Short Chain Fatty Acids, acetate, propionate, and butyrate, will be targeted. Final concentrations will be calculated based on internal standards and are expressed as micromoles per gram of wet feces (μmol/g). Techniques and predictive approaches will be used across. gas chromatography will be used to quantify Short Chain Fatty Acids from fecal samples

  at baseline and after 12 weeks

• assessment of lipid profile

  Fasting blood samples were collected after an overnight fast, and serum lipid levels were analyzed using standard enzymatic methods with an automated biochemical analyzer. The lipid profile included triglycerides, total cholesterol, low-density lipoprotein cholesterol, and high-density lipoprotein cholesterol to assess lipid metabolism and cardiovascular risk.

  at baseline and after 12 weeks

Secondary Outcomes (1)

• assessment of quality of life

  at baseline and after 12 weeks

Study Arms (3)

high intensity interval training and Mediterranean diet

EXPERIMENTAL

This study will involve 20 patients with Non-alcoholic Fatty Liver disease undergoing individualized High-Intensity Interval Training for 12 weeks. The exercise regimen includes 3 sessions per week, featuring 3 sets of 3 minutes of high-intensity intervals at 70-90% heart rate reserve, with 2 minutes of active recovery between intervals. All exercise will be supervised on a treadmill, complemented by a Mediterranean diet.

Other: High intensity interval training; Other: Mediterranean diet

moderate intensity continous training and Mediterranean diet

EXPERIMENTAL

This group will include 20 patients with non-alcoholic Fatty Liver disease they will receive moderate intensity continous training protocol consisted of 3× 3 min of moderate -intensity intervals at 40- 60% heart rate reserve for 30 min, in addition to Mediterranean diet.

Other: moderate intensity continuous training; Other: Mediterranean diet

Mediterranean Diet

ACTIVE COMPARATOR

It is characterized by a high consumption of plant-based foods, such as vegetables, fruits, whole grains, seeds, nuts and legumes, and moderate consumption of protein-source foods such as fish and poultry. This diet is rich in monounsaturated fatty acids primarily from olive oil and olives, reduced fat dairy products and low red meat intake.

Other: Mediterranean diet

Interventions

High intensity interval training OTHER

Patients will engage in high-intensity interval training using heart rate reserve (HRR) to determine exercise intensity. The program includes three sessions per week for 12 weeks, featuring three 3-minute high-intensity intervals at 70-90% HRR, with 2 minutes of active recovery in between. Each 30-minute session will be treadmill-based under supervision, incorporating warm-up and cool-down periods. Participants will also follow a Mediterranean diet.

high intensity interval training and Mediterranean diet

moderate intensity continuous training OTHER

The program will be in form of: * Frequency: 3 sessions/week for 12 weeks. * Intensity: Moderate intensity continues training at 40- 60% HRR. * Duration: the session will last 30 minutes per session. Patients will be instructed to follow Mediterranean Diet.

moderate intensity continous training and Mediterranean diet

Mediterranean diet OTHER

the composition of the Mediterranean diet, emphasizing that vegetables and fruits make up the largest portion at 35%, followed by whole grains (20%) and fish and seafood (15%). Legumes and nuts account for 10%, while olive oil and dairy products (cheese and yogurt) each contribute 7%. Smaller portions include poultry and eggs (4%) and red meat and sweets (2%), reflecting the diet's focus on plant-based foods, healthy fats, whole grains, and moderate consumption of animal products, with minimal intake of red meat and sugary foods.

Mediterranean Diet; high intensity interval training and Mediterranean diet; moderate intensity continous training and Mediterranean diet

Eligibility Criteria

• Age: 40 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients from both genders aged 40 - 60 years old diagnosed with Non-alcoholic Fatty Liver disease by ultrasonography.
• Body mass index will range from 30 to 34.9 kg/m².
• Patients with central obesity (waist circumference 90 cm for men and 85 cm for women).
• Patients who have taken no regular exercise in the last year (\<3 times/week and 30 min/time.
• No antibiotic or probiotic use for at least last 3 months.
• Medical drugs such as metformin, sulfonylureas, statins, and blood pressure medication were eligible, as well as stable.

You may not qualify if:

• History of liver cirrhosis or other chronic liver diseases.
• Use of medications affecting gut microbiota (e.g., laxatives, metformin, proton pump inhibitors).
• Recent gastrointestinal infections or surgeries.
• Diabetes Mellitus type 1 or uncontrolled type 2.
• Cardiovascular, respiratory, or musculoskeletal disorders limiting exercise capacity.
• Active smokers.
• Pregnancy or breastfeeding.
• Uncontrolled hypertension.
• Communication disorders.
• Bleeding disorders.

Sponsors & Collaborators

• Horus University: lead

Study Sites (1)

out-patient clinic, faculty of physical therapy, Horus university

Cairo, Egypt

Location

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Interventions

High-Intensity Interval Training; Diet, Mediterranean

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Diet, Plant-Based; Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Central Study Contacts

Heba Yasser Bihery, Assistant lecturer

CONTACT

01065015529; hyasser@horus.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 5, 2026
• First Posted: July 13, 2026
• Study Start: July 10, 2026
• Primary Completion: September 10, 2026
• Study Completion (Estimated): October 10, 2026
• Last Updated: July 13, 2026

Record last verified: 2026-07

Locations

EG (1)