Homeopathy for Overweight and Obesity in Mexican Adolescents

NCT03945396 | Unknown Phase 2 DMC

• 1 other identifier: HJM 0572/19-1
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Overweight and Obesity

Keywords

Obesity; Overweight; Homeopathy; Calcarea carbonica ostrearum; Mexico

Outcome Measures

Primary Outcomes (2)

• Change from baseline in mean total weight in kilograms (kg)

  Weight measured with the participants barefooted and lightly dressed, with a Tanita scale Fitscan BC-545 F segmental body composition monitor. The scale has an eight electrode body composition monitor that displays twenty readings; ten whole body and ten segmental (arms, legs and trunk area).

  At baseline and week 4, 8 and 12.

• Change from baseline in percentage of body fat

  Body fat measured with Tanita scale Fitscan BC-545 F segmental body composition monitor. Values greater than 30% for females, and 25% for males, are considered high and of risk

  At baseline and week 4, 8 and 12.

Secondary Outcomes (6)

• Change from baseline in mean total body mass index (BMI).

  At baseline and week 4, 8 and 12.

• Change from baseline in mean total fat mass index

  At baseline and week 4, 8 and 12.

• Change from baseline in mean total lean body mass (kg).

  At baseline and week 4, 8 and 12.

• Change from baseline waist-hip ratio.

  At baseline and week 4, 8 and 12.

• Change from baseline in mean total lean muscle mass (kg).

  At baseline and week 4, 8 and 12.

Other Outcomes (11)

• Change from baseline in mean total fasting serum glucose (mg/dL)

  At baseline and week 12.

• Change from baseline in mean total fasting serum triglycerides (mg/dL)

  At baseline and week 12.

• Change from baseline in mean total cholesterol (mg/dL)

  At baseline and week 12.

Study Arms (2)

Multidisciplinary intervention + homeopathic medication

EXPERIMENTAL

Multidisciplinary intervention (diet, exercise program, motivational support) and Calcarea carbonica ostrearum 30c. A single dose of Calcarea carbonica ostrearum 30C dissolved in a 30 ml bottle of 30% alcohol-distilled water. Patients will receive 8 drops PO three times per day prior agitation.

Drug: Homeopathic Medication; Other: Multidisciplinary intervention (Exercise program, diet, motivational support)

Multidisciplinary intervention + homeopathic placebo

ACTIVE COMPARATOR

Multidisciplinary intervention (diet, exercise program, motivational support) and placebo. Placebo will be prepared with 30% alcohol-distilled water only, in the same 30 ml bottle. Patients will receive 8 drops PO three times per day prior agitation.

Other: Multidisciplinary intervention (Exercise program, diet, motivational support); Drug: Homeopathic placebo

Interventions

Homeopathic Medication DRUG

A homeopathic mineral medicine, form of impure calcium carbonate, CaCO3, which can be found in nature in different niches, from limestone to eggshells.

Also known as: Calcarea carbonica ostrearum

Multidisciplinary intervention + homeopathic medication

Multidisciplinary intervention (Exercise program, diet, motivational support) OTHER

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.

Also known as: Combined dietary-behavioral-physical activity intervention

Multidisciplinary intervention + homeopathic medication; Multidisciplinary intervention + homeopathic placebo

Homeopathic placebo DRUG

A 30 ml bottle of 30% alcohol-distilled water.

Also known as: Placebo

Multidisciplinary intervention + homeopathic placebo

Eligibility Criteria

• Age: 12 Years - 19 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• to 19 years old.
• At least elementary school.
• Overweight (BMI ≥ 85th but \<95th percentile based on the Centers for Disease Control and Prevention growth chart) or obese (BMI ≥95th percentile).
• Fasting serum glucose \<126 mg/dl.
• Glycosylated hemoglobin \<6.5%.
• With symptoms that match with Calcarea carbonica ostrearum.
• Willingness to participate, and verbal and written consent.

You may not qualify if:

• Pregnancy or breastfeeding.
• Cases already undergoing treatment (homeopathic, nutritional or structured physical activity) for obesity within last three months.
• Currently use of metformin, orlistat, insulin, other antidiabetic medication, contraceptive pills, medications with effects on lipid metabolism \[thiazide and loop diuretics, β and α receptor blockers, antiepileptic drugs (carbamazepine, phenytoin, valproic acid, phenobarbital), antipsychotics (clozapine), protease inhibitors (amprenavir, indinavir, nelfinavir, ritonavir, saquinavir), tamoxifen, raloxifene, isotretinoin, acitretin, ciclosporin, azathioprine, sirolimus\].
• Any condition that prevents physical exercise.
• Diabetes, hypertension, thyroid diseases, Down syndrome, mental retardation.

Sponsors & Collaborators

• Hospital Juarez de Mexico: lead

Study Sites (1)

Hospital Juárez de México

Mexico City, 07760, Mexico

Location

Related Publications (1)

• Macias-Cortes E, Arellano-Alvarez S, Vega-Monroy S, Vera-Perez V, Llanes-Gonzalez L, Sanchez-Navarrete P, Enciso-Gonzalez D. Efficacy of Homeopathy in Addition to a Multidisciplinary Intervention for Overweight or Obesity in Mexican Adolescents: Study Protocol for a Randomized, Double-Blind, Placebo-Controlled Trial. Homeopathy. 2020 May;109(2):87-96. doi: 10.1055/s-0039-1697927. Epub 2020 Jan 20.

  PMID: 31958867 DERIVED

MeSH Terms

Conditions

Overweight; Obesity

Interventions

Diet

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Double-blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of homeopathy outpatient service

Model Details: A randomized, placebo-controlled, double-blind, parallel, superiority trial with 3 month study duration.

Study Record Dates

• First Submitted: May 7, 2019
• First Posted: May 10, 2019
• Study Start: May 6, 2019
• Primary Completion: November 30, 2022
• Study Completion: December 30, 2022
• Last Updated: August 25, 2021

Record last verified: 2021-08

Locations

ME (1)