Back to resultsHomeopathy for Overweight and Obesity in Mexican Adolescents
Primary Purpose
Overweight and Obesity
Status
Unknown status
Phase
Phase 2
Locations
Mexico
Study Type
Interventional
Intervention
Homeopathic Medication
Multidisciplinary intervention (Exercise program, diet, motivational support)
Homeopathic placebo
Sponsored by
About this trial
This is an interventional treatment trial for Overweight and Obesity focused on measuring Obesity, Overweight, Homeopathy, Calcarea carbonica ostrearum, Mexico
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.
Sites / Locations
- Hospital Juárez de México
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Multidisciplinary intervention + homeopathic medication
Multidisciplinary intervention + homeopathic placebo
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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).
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
Secondary Outcome Measures
Change from baseline in mean total body mass index (BMI).
Weight/height2 (kg/m2). Overweight (BMI ≥ 85th but <95th percentile based on the Centers for Disease Control and Prevention growth chart) or obese (BMI ≥95th percentile).
Change from baseline in mean total fat mass index
Calculated by dividing fat weight in kilograms by height in meters squared.
Change from baseline in mean total lean body mass (kg).
Calculated by subtracting body fat weight from total body weight: total body weight is lean plus fat
Change from baseline waist-hip ratio.
Calculated as waist measurement divided by hip measurement.
Change from baseline in mean total lean muscle mass (kg).
Calculated by total weight of the body minus all the weight due to the fat mass.
Number and severity of all adverse events
Adverse event will be defined as any untoward medical occurrence in a subject without regard to the possibility of a causal relationship.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03945396
Brief Title
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
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Unknown status
Study Start Date
May 6, 2019 (Actual)
Primary Completion Date
November 30, 2022 (Anticipated)
Study Completion Date
December 30, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital Juarez de Mexico
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight and Obesity
Keywords
Obesity, Overweight, Homeopathy, Calcarea carbonica ostrearum, Mexico
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
A randomized, placebo-controlled, double-blind, parallel, superiority trial with 3 month study duration.
Masking
ParticipantCare ProviderInvestigator
Masking Description
Double-blind
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Multidisciplinary intervention + homeopathic medication
Arm Type
Experimental
Arm Description
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.
Arm Title
Multidisciplinary intervention + homeopathic placebo
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Homeopathic Medication
Other Intervention Name(s)
Calcarea carbonica ostrearum
Intervention Description
A homeopathic mineral medicine, form of impure calcium carbonate, CaCO3, which can be found in nature in different niches, from limestone to eggshells.
Intervention Type
Other
Intervention Name(s)
Multidisciplinary intervention (Exercise program, diet, motivational support)
Other Intervention Name(s)
Combined dietary-behavioral-physical activity intervention
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Homeopathic placebo
Other Intervention Name(s)
Placebo
Intervention Description
A 30 ml bottle of 30% alcohol-distilled water.
Primary Outcome Measure Information:
Title
Change from baseline in mean total weight in kilograms (kg)
Description
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).
Time Frame
At baseline and week 4, 8 and 12.
Title
Change from baseline in percentage of body fat
Description
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
Time Frame
At baseline and week 4, 8 and 12.
Secondary Outcome Measure Information:
Title
Change from baseline in mean total body mass index (BMI).
Description
Weight/height2 (kg/m2). Overweight (BMI ≥ 85th but <95th percentile based on the Centers for Disease Control and Prevention growth chart) or obese (BMI ≥95th percentile).
Time Frame
At baseline and week 4, 8 and 12.
Title
Change from baseline in mean total fat mass index
Description
Calculated by dividing fat weight in kilograms by height in meters squared.
Time Frame
At baseline and week 4, 8 and 12.
Title
Change from baseline in mean total lean body mass (kg).
Description
Calculated by subtracting body fat weight from total body weight: total body weight is lean plus fat
Time Frame
At baseline and week 4, 8 and 12.
Title
Change from baseline waist-hip ratio.
Description
Calculated as waist measurement divided by hip measurement.
Time Frame
At baseline and week 4, 8 and 12.
Title
Change from baseline in mean total lean muscle mass (kg).
Description
Calculated by total weight of the body minus all the weight due to the fat mass.
Time Frame
At baseline and week 4, 8 and 12.
Title
Number and severity of all adverse events
Description
Adverse event will be defined as any untoward medical occurrence in a subject without regard to the possibility of a causal relationship.
Time Frame
After participants consent and enrolled in the study and 15 days after study completion.
Other Pre-specified Outcome Measures:
Title
Change from baseline in mean total fasting serum glucose (mg/dL)
Description
Blood samples will be collected by venipuncture in the antecubital region of patients after 10-12 hours of overnight fasting and centrifuged within 30-45 min of collection, using an automated chemical analyzer (Advia®1200). Glucose will be assayed by the glucose-oxidase method.
Time Frame
At baseline and week 12.
Title
Change from baseline in mean total fasting serum triglycerides (mg/dL)
Description
Blood samples will be collected by venipuncture in the antecubital region of patients after 10-12 hours of overnight fasting and centrifuged within 30-45 min of collection, using an automated chemical analyzer (Advia®1200).
Time Frame
At baseline and week 12.
Title
Change from baseline in mean total cholesterol (mg/dL)
Description
Blood samples will be collected by venipuncture in the antecubital region of patients after 10-12 hours of overnight fasting and centrifuged within 30-45 min of collection, using an automated chemical analyzer (Advia®1200).
Time Frame
At baseline and week 12.
Title
Change from baseline in mean total high-density cholesterol (mg/dL)
Description
Blood samples will be collected by venipuncture in the antecubital region of patients after 10-12 hours of overnight fasting and centrifuged within 30-45 min of collection, using an automated chemical analyzer (Advia®1200).
Time Frame
At baseline and week 12.
Title
Change from baseline in mean total low-density cholesterol (mg/dL)
Description
Blood samples will be collected by venipuncture in the antecubital region of patients after 10-12 hours of overnight fasting and centrifuged within 30-45 min of collection, using an automated chemical analyzer (Advia®1200).
Time Frame
At baseline and week 12.
Title
Change from baseline in percentage of glycosylated hemoglobin
Description
Blood samples will be collected by venipuncture in the antecubital region of patients after 10-12 hours of overnight fasting and centrifuged within 30-45 min of collection, using an automated chemical analyzer (Advia®1200).
Time Frame
At baseline and week 12.
Title
Change from baseline in mean total insulin (mU/ml)
Description
Blood samples will be collected by venipuncture in the antecubital region of patients after 10-12 hours of overnight fasting and centrifuged within 30-45 min of collection, using a chemiluminescence technique (Immulite®2000TSH Third Generation).
Time Frame
At baseline and week 12.
Title
Change from baseline in mean total thyroid-stimulating hormone (mU/L)
Description
Blood samples will be collected by venipuncture in the antecubital region of patients after 10-12 hours of overnight fasting and centrifuged within 30-45 min of collection, using a chemiluminescence technique (Immulite®2000TSH Third Generation).
Time Frame
At baseline and week 12.
Title
Change from baseline in mean total HOMA-IR.
Description
The homeostasis model assessment (HOMA), an epidemiologic method for assessing insulin resistance [HOMA-IR=insulin (mU/ml) X glucose (mg/dl)/405] will be used as surrogate measure of insulin sensitivity
Time Frame
At baseline and week 12.
Title
Change from baseline in mean total score of CES-D-R
Description
CESDR scale measure symptoms of depression in nine different groups as defined by the American Psychiatric Association Diagnostic and Statistical Manual, fifth edition. The Total CESD-R Score is calculated as a sum of responses to all 20 questions. The range of possible scores is between 0 (for those who say 'not at all or less than one day to all 20 questions' and 60 (for those who say '5-7 days' or 'nearly every day for 2 weeks' for all 20 questions). No clinical significance: a total CESD-R score less than 16 across all 20 questions.
Time Frame
At baseline and week 12.
Title
Change from baseline in mean total score of Screen for Child Anxiety Related Emotional Disorders (SCARED).
Description
Appropriate screening tool to aid the diagnosis of anxiety disorders in adolescents attending an outpatient clinic.It consists of 41 items that are rated from 0 to 2, being 0 never, 1 sometimes and 2 always. The cut-off point is 25, that is, there is a probability of at least 70% that the child or adolescent has an anxiety disorder.
Time Frame
At baseline and week 12.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Hospital Juárez de México
City
Mexico City
ZIP/Postal Code
07760
Country
Mexico
12. IPD Sharing Statement
Citations:
PubMed Identifier
31958867
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.
Results Reference
derived
Learn more about this trial
Homeopathy for Overweight and Obesity in Mexican Adolescents
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