NCT03945396

Homeopathy for Overweight and Obesity in Mexican Adolescents

Efficacy of a Multidisciplinary Intervention and Homeopahy for Overweight or Obesity in Mexican Adolescents: a Study Protocol for a Randomized Double-blind, Placebo-controlled Trial

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Hospital Juarez de Mexico · Other Government
• Sex: All
• Age: 12 Years – 19 Years
• Healthy volunteers: Not accepted

Summary

This study evaluates the efficacy of a multidisciplinary intervention (diet, exercise, motivational support and homeopathy or placebo) for overweight and obesity in Mexican adolescents. Half of study participants will receive the multidisciplinary intervention plus Calcarea carbonica ostrearum, a homeopathic medicine, while the other half will receive the same multidisciplinary intervention plus placebo.

Detailed description

Overweight and obesity in children and adolescents are a major public health issue in Mexico. Whilst many factors (genetic, cultural, socioeconomic and environmental) contribute to develop obesity during childhood, a multidisciplinary intervention (nutritional, behavioral and exercise) is the best approach to improve weight loss. In Mexico, the use of homeopathy for obesity is widespread. Although there are some homeopathic medicines used for obese individuals, there is a lack of well-designed clinical trials to demonstrate its efficacy in weight loss. Calcarea carbonica ostrearum is a homeopathic mineral medicine. Previously, it has been demonstrated that Calcarea carbonica has an effect in reducing the percentage of fat in adolescents. Therefore, a randomized, placebo-controlled, double-blind, parallel, superiority trial with a 3 month study duration, will be conducted to prove the efficacy and safety of Calcarea carbonica ostrearum in reducing weight, body mass index (BMI) and fat percentage, as well as, to prove its effect on the lipid profile, fasting serum glucose, glycosylated hemoglobin and insulin.

Conditions

• Overweight and Obesity

Interventions

Type	Name	Description
DRUG	Homeopathic Medication	A homeopathic mineral medicine, form of impure calcium carbonate, CaCO3, which can be found in nature in different niches, from limestone to eggshells.
OTHER	Multidisciplinary intervention (Exercise program, diet, motivational support)	Exercise program: includes a five-times per week routine: warm-up during 10 to 15 minutes, then 40 minutes of aerobic exercise that will be increased progressively until reaching 60 minutes. Thereafter, muscular strength initiating 5%, and increasing until 10 to 15% of body weight. Then, 10 to 15 minutes of stretching. Finally, 5 min cool-down. Diet: Subjects will receive a balance diet calculated based on energetic needs according FAO: 15-20% of proteins, 50-60% of carbohydrate, 20-25% of fat per day. Motivational support: 50 min session where empathy and neutral understanding of the perspective and feelings of the adolescent, and his family, are fostered to motivate the change and to state realistic goals in reducing weight.
DRUG	Homeopathic placebo	A 30 ml bottle of 30% alcohol-distilled water.

Timeline

• Start date: 2019-05-06
• Primary completion: 2022-11-30
• Completion: 2022-12-30
• First posted: 2019-05-10
• Last updated: 2021-08-25

Locations

1 site across 1 country: Mexico