Clinical trial NCT03945396: Homeopathy for Overweight and Obesity in Mexican Adolescents
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Overweight and Obesity
Keywords: Obesity
Overweight
Homeopathy
Calcarea carbonica ostrearum
Mexico
Lead sponsor: Hospital Juarez de Mexico
Sponsor class: OTHER_GOV
First posted: 2019-05-10
Enrollment: 60
Sex: ALL
Minimum age (years): 12
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A randomized, placebo-controlled, double-blind, parallel, superiority trial with 3 month study duration.
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: Inclusion Criteria:

* 12 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Change from baseline in mean total weight in kilograms (kg)
timeFrame: At baseline and week 4, 8 and 12.
measure: Change from baseline in percentage of body fat
timeFrame: At baseline and week 4, 8 and 12.
Secondary outcomes:
measure: Change from baseline in mean total body mass index (BMI).
timeFrame: At baseline and week 4, 8 and 12.
measure: Change from baseline in mean total fat mass index
timeFrame: At baseline and week 4, 8 and 12.
measure: Change from baseline in mean total lean body mass (kg).
timeFrame: At baseline and week 4, 8 and 12.
measure: Change from baseline waist-hip ratio.
timeFrame: At baseline and week 4, 8 and 12.
measure: Change from baseline in mean total lean muscle mass (kg).
timeFrame: At baseline and week 4, 8 and 12.
measure: Number and severity of all adverse events
timeFrame: After participants consent and enrolled in the study and 15 days after study completion.
Other outcomes:
measure: Change from baseline in mean total fasting serum glucose (mg/dL)
timeFrame: At baseline and week 12.
measure: Change from baseline in mean total fasting serum triglycerides (mg/dL)
timeFrame: At baseline and week 12.
measure: Change from baseline in mean total cholesterol (mg/dL)
timeFrame: At baseline and week 12.
measure: Change from baseline in mean total high-density cholesterol (mg/dL)
timeFrame: At baseline and week 12.
measure: Change from baseline in mean total low-density cholesterol (mg/dL)
timeFrame: At baseline and week 12.
measure: Change from baseline in percentage of glycosylated hemoglobin
timeFrame: At baseline and week 12.
measure: Change from baseline in mean total insulin (mU/ml)
timeFrame: At baseline and week 12.
measure: Change from baseline in mean total thyroid-stimulating hormone (mU/L)
timeFrame: At baseline and week 12.
measure: Change from baseline in mean total HOMA-IR.
timeFrame: At baseline and week 12.
measure: Change from baseline in mean total score of CES-D-R
timeFrame: At baseline and week 12.
measure: Change from baseline in mean total score of Screen for Child Anxiety Related Emotional Disorders (SCARED).
timeFrame: At baseline and week 12.
Locations:
city: Mexico City
country: Mexico
facility: Hospital Juárez de México
Study officials:
References:
citation: 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.