Metabolic Flexibility and Metabolic Heath in Human Obesity

NCT07355933 | Completed

• 1 other identifier: 200602001
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

Brief Summary

This interventional study explores the relationship between improvements in metabolic health following weight loss and changes in whole-body fat mass and its distribution. The study focuses on adult men and women with excess body weight undergoing dietary energy restriction over 12 weeks. The primary research question is: Does a greater reduction in fat mass for a given weight loss correlate with more significant improvements in metabolic health?

Conditions

Obesity

Keywords

OBESITY; WEIGHT LOSS; EATING BEHAVIOR; METABOLIC FLEXIBILITY; BODY COMPOSITION

Outcome Measures

Primary Outcomes (1)

• Fasting serum triglyceride concentration

  In overnight fasted individuals, a blood sample will be drawn. Serum will be isolated and stored at -80C until assessment.

  From enrollment to the end of weight maintenance period at 15-20 weeks

Secondary Outcomes (1)

• HOMA-IR

  From enrollment to the end of weight maintenance period at 15-20 weeks.

Study Arms (1)

Weight Loss Intervention

OTHER

Individuals with overweight or obesity will undergo dietary energy restriction aimed to induce 8 to 12% weight loss after 12 weeks. For 3 to 5 weeks, body weight will be maintained.

Other: Body Weight Loss

Interventions

Body Weight Loss OTHER

Individuals will be prescribed a hypocaloric diet (1300 kcal/d). Individuals will receive a booklet detailing the type of meals and foods to be consumed in each mealtime. A dietitian will explain how to enhance dietary compliance. Every two weeks, body weight, vital signs, and adverse events will be monitored. In addition, food recalls will be conducted in order to optimize dietary energy restriction compliance. During weight maintenance, energy intake will be adjusted to energy requirements to maintain weight stability (±2.5 kg) for at least 3 weeks. During weight loss and maintenance, participants will be instructed to maintain their customary physical activity.

Weight Loss Intervention

Eligibility Criteria

• Age: 30 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• males or females
• y old
• physically inactive (\<600 MET´min/wk of self-reported moderate-vigorous physical activity
• stable body weight for at least the past 6 months (±2 kg)
• healthy according to medical history and routine hematology and biochemistry.

You may not qualify if:

• Individuals with physiological (pregnancy, lactation) or pathological (under drug therapy for and/or having cardiovascular, liver, kidney, thyroid diseases)
• conditions affecting energy metabolism or eating behavior
• Subjects having low-fat (\<20% energy) or low-carbohydrate (\<45% energy) diets
• Smokers and alcohol abusers

Sponsors & Collaborators

• Jose Galgani: lead
• Agencia Nacional de Investigación y Desarrollo: collaborator

Study Sites (1)

Avda. Libertador Bernardo O´Higgins 340. Santiago. Chile.

Santiago, Chile

Location

MeSH Terms

Conditions

Obesity; Weight Loss; Feeding Behavior

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Responsible Principal Investigator

Study Record Dates

• First Submitted: July 25, 2025
• First Posted: January 21, 2026
• Study Start: September 23, 2022
• Primary Completion: January 6, 2025
• Study Completion: January 6, 2025
• Last Updated: February 27, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

CL (1)