Overweight and ObesityPhase 2NCT03945396
Homeopathy for Overweight and Obesity in Mexican Adolescents
A Phase 2 study testing Homeopathic Medication and Multidisciplinary intervention (Exercise program, diet, motivational support) in people with Overweight and Obesity, run by Hospital Juarez de Mexico at 1 site in Mexico.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 19 years
- Conditions the study is for
- Overweight and Obesity
- What is being tested?
- Homeopathic Medication and Multidisciplinary intervention (Exercise program, diet, motivational support)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteMexico
- Study dates
- 6 May 2019to 30 Dec 2022
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 19 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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
- Being tested
- Homeopathic Medication, Multidisciplinary intervention (Exercise program, diet, motivational support), Homeopathic placebo
- Keywords
- Obesity, Overweight, Homeopathy, Calcarea carbonica ostrearum, Mexico
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Homeopathic MedicationDrug
Also called Calcarea carbonica ostrearum
A homeopathic mineral medicine, form of impure calcium carbonate, CaCO3, which can be found in nature in different niches, from limestone to eggshells.
Multidisciplinary intervention (Exercise program, diet, motivational support)Other
Also called Combined dietary-behavioral-physical activity intervention
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.
Homeopathic placeboDrug
Also called Placebo
A 30 ml bottle of 30% alcohol-distilled water.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Multidisciplinary intervention (Exercise program, diet, motivational support); Drug: Homeopathic placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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
Measured: At baseline and week 4, 8 and 12.
Secondary outcomes (6)
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).
Measured: At baseline and week 4, 8 and 12.
Change from baseline in mean total fat mass index
Calculated by dividing fat weight in kilograms by height in meters squared.
Measured: At baseline and week 4, 8 and 12.
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
Measured: At baseline and week 4, 8 and 12.
Change from baseline waist-hip ratio.
Calculated as waist measurement divided by hip measurement.
Measured: At baseline and week 4, 8 and 12.
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.
Measured: At baseline and week 4, 8 and 12.
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.
Measured: After participants consent and enrolled in the study and 15 days after study completion.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2019
- Study start6 May 2019
- Primary completion30 Nov 2022 (estimated)
- Study completion30 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Overweight and ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A randomized, placebo-controlled, double-blind, parallel, superiority trial with 3 month study duration.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Juarez de Mexico
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Emma del Carmen Macías-Cortés, MD, PhD, Hospital Juarez de Mexico
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03945396
- Sponsor's protocol ID
- HJM 0572/19-1
- Status last verified
- Aug 2021
- First submitted
- 7 May 2019
- Last updated
- 25 Aug 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 31958867
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03945396
- Acronym / sponsor ID
- HJM 0572/19-1
- Conditions
- Overweight and Obesity
- Keywords
- Obesity, Overweight, Homeopathy, Calcarea carbonica ostrearum, Mexico
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Hospital Juarez de MexicoOther government
- Study start
- 6 May 2019 (actual)
- Primary completion
- 30 Nov 2022 (estimated)
- Study completion
- 30 Dec 2022 (estimated)
- First posted
- 10 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- A randomized, placebo-controlled, double-blind, parallel, superiority trial with 3 month study duration.
| Arm | Type | Receives |
|---|---|---|
| Multidisciplinary intervention + homeopathic medication | Experimental | Drug: Homeopathic Medication, Other: Multidisciplinary intervention (Exercise program, diet, motivational support)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 + homeopathic placebo | Active comparator | Other: Multidisciplinary intervention (Exercise program, diet, motivational support), Drug: Homeopathic placeboMultidisciplinary 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. |
Who may qualify
- Ages
- 12 to 19 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- 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%.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Homeopathic MedicationAlso: Calcarea carbonica ostrearumA homeopathic mineral medicine, form of impure calcium carbonate, CaCO3, which can be found in nature in different niches, from limestone to eggshells. | Drug | Multidisciplinary intervention + homeopathic medication |
| Multidisciplinary intervention (Exercise program, diet, motivational support)Also: Combined dietary-behavioral-physical activity interventionExercise 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. | Other | Multidisciplinary intervention + homeopathic medication, Multidisciplinary intervention + homeopathic placebo |
| Homeopathic placeboAlso: PlaceboA 30 ml bottle of 30% alcohol-distilled water. | Drug | Multidisciplinary intervention + homeopathic placebo |
Primary outcome
Change from baseline in mean total weight in kilograms (kg)
Time frame: At baseline and week 4, 8 and 12.
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
Time frame: At baseline and week 4, 8 and 12.
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
6 secondary outcomes
Change from baseline in mean total body mass index (BMI).
Time frame: At baseline and week 4, 8 and 12.
Change from baseline in mean total fat mass index
Time frame: At baseline and week 4, 8 and 12.
Change from baseline in mean total lean body mass (kg).
Time frame: At baseline and week 4, 8 and 12.
Change from baseline waist-hip ratio.
Time frame: At baseline and week 4, 8 and 12.
Change from baseline in mean total lean muscle mass (kg).
Time frame: At baseline and week 4, 8 and 12.
Number and severity of all adverse events
Time frame: After participants consent and enrolled in the study and 15 days after study completion.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2021.
- Derived from this study: PubMed 31958867Macias-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Homeopathic Medication and Multidisciplinary intervention (Exercise program, diet, motivational support) in people with Overweight and Obesity, run by Hospital Juarez de Mexico at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in mean total weight in kilograms (kg) (time frame: At baseline and week 4, 8 and 12.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03945396, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2021.