ObesityNCT06676605
Impact of Ashwagandha in Obesity Parameters from Mexican Adults
A study testing Withania somnifera in people with Obesity and Overweight, run by Ivan Luzardo-Ocampo at 1 site in Mexico.
Trial summary
This clinical trial aimed to assess the impact of ashwagandha supplementation on serum lipid concentrations and body composition in Mexican adults with overweight and obesity. It was a double-blind, placebo-controlled pilot study, including adult patients who consumed ashwagandha pills for 40 days after giving… Read more about this study
- Who is it for?
- Ages 29 to 38 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Overweight
- What is being tested?
- Withania somnifera
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 34 participants
- Where
- 1 siteMexico
- Study dates
- 10 Jan 2023to 30 Jan 2024
- Phase
- Interventional
- 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 29 to 38 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Participants who are willing to comply with the study guidelines for a 40-day period.
- Individuals who consent to undergo initial anthropometric and biochemical analyses.
- Participants willing to follow personalized meal plans.
- Individuals who agree to receive reminders and monitoring communication via email and/or text messages.
Who cannot join
- Individuals with known allergies or intolerances to Withania somnifera or starch rice.
- Participants who are unable or unwilling to follow the daily supplementation regimen.
- Individuals with medical conditions that might interfere with the study results or pose a health risk when taking the supplement.
- Participants currently taking any other supplements or medications that could interfere with the study outcomes.
Trial locations and contacts
1 site in 1 country.
Mexico1 site
Nutrition Department at Universidad Autonoma de Nuevo Leon
Monterrey, Nuevo León, 66238
About this study
Official title: Assessment of Ashwagandha Pills Consumption in the Amelioration of Obesity-associated Parameters in Mexican Adults with Overweight and Obesity
This clinical trial aimed to assess the impact of ashwagandha supplementation on serum lipid concentrations and body composition in Mexican adults with overweight and obesity. It was a double-blind, placebo-controlled pilot study, including adult patients who consumed ashwagandha pills for 40 days after giving informed consent. Two groups were part of the study: an experimental group receiving the supplement and a placebo group. Measurements conducted included anthropometric parameters and blood biochemical parameters.
Read the detailed description
This clinical trial aimed to assess the impact of ashwagandha supplementation on serum lipid concentrations and body composition in Mexican adults with overweight and obesity through a double-blind, randomized, placebo-controlled protocol. The study included adult patients who met inclusion such as a Body Mass Index (BMI) of 25 kg/m^2 or higher, glucose levels around 100 mg/dL, LDL-C levels of 160 mg/dL or higher, total cholesterol levels of 200 mg/dL or higher, HDL-C levels lower than 40 mg/dL, and triglyceride levels exceeding 150 mg/dL). Patients were excluded if they were pregnant, had diabetes mellitus, hypertension, or hypersensitivity to Solanaceae products.
Volunteers signed an informed consent form as per NOM-012-SSA3-2012 guidelines, detailing the study's purpose and terms. Participants adhered to a prescribed dietary plan that included Ashwagandha (Withania somnifera) supplementation and consented to monitoring of their dietary intake and biochemical parameters measurement.
The ashwagandha supplementation involved 500 mg capsules taken daily for 40 days, with an intervention group (W. somnifera supplementation, 500 mg/day, n=17) and a placebo group (starch rice capsule/tablet/day, n=17). Both groups received personalized meal plans to ensure that observed changes were directly attributable to the supplements.
Anthropometric measurements included body weight, waist circumference, and BMI. Blood samples were extracted after 12 hours of fasting using a vacutainer system, and biochemical determinations were processed the same day with semi-automated equipment via COBAS® colorimetric methods. Parameters such as glucose, triglycerides, cholesterol, LDL-c, HDL-c, and VLDL-c were analyzed.
Sociodemographic data were described by gender, while clinical and anthropometric variables were categorized by intervention and control groups. Quantitative variables were compared using the student's t-test for related samples. Significant differences between baseline and experimental groups were found for total cholesterol, HDL, LDL, VLDL, the LDL/HDL-c ratio, and triglycerides.
- Conditions
- Obesity, Overweight
- Being tested
- Withania somnifera, Placebo Intervention
- Medical subject headings
- Obesity, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Withania somniferaDietary supplement
Also called Ashwagandha
The experimental supplement administered to patients in this study was Withania somnifera, commonly known as ashwagandha. It is classified as a dietary supplement and is regulated similarly to pharmaceutical medications. The supplement has been authorized for commercialization and use by the Food and Drug Administration (FDA). Participants received the supplement in the form of 500 mg capsules, taken daily over a 40-day period, following the manufacturer's instructions. The range of the recommended daily dose is between 240 and 600 mg. The purpose of administering this supplement was to evaluate its impact on various health parameters, including serum lipid concentrations and body composition, in the study's participants.
Placebo InterventionOther
Also called Pills
The product administered to the placebo group was designed to simulate the appearance and administration of the experimental supplement but without containing any active ingredients. Participants in the placebo group received capsules/tablets filled with starch rice. These capsules were taken daily over the same 40-day period as the experimental group, ensuring that the placebo group followed identical administration and monitoring procedures. The use of starch rice capsules aimed to serve as a neutral control, allowing for a comparison between the effects of the actual Withania somnifera supplement and the placebo.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | The intervention group consisted of 17 participants who were administered a dietary supplement of Withania somnifera, classified as such and subject to FDA regulations comparable to pharmaceutical medications. Over a period of 40 days, participants in this group consumed 500 mg capsules of W. somnifera daily, in accordance with the manufacturer's instructions and within the recommended dose range of 240-600 mg. Prior to the supplementation period, comprehensive anthropometric and biochemical analyses were carried out to establish baseline measurements. Members of this group also received personalized meal plans to ensure that any observed changes were a direct result of the supplementation. Additionally, participants were closely monitored via email and/or text messages to remind them of study guidelines, address any questions or concerns, and watch for potential adverse effects. Receives: Dietary Supplement: Withania somnifera |
| Placebo Group | Placebo comparator | The placebo group also comprised 17 participants who were given a capsule/tablet of starch rice daily for the same 40-day period. Like the intervention group, participants in the placebo group underwent initial anthropometric and biochemical analyses to set baseline measurements before starting the supplementation period. This group similarly received personalized meal plans to ensure that any observed changes could be accurately attributed to the placebo effect. The placebo group participants were monitored via email and/or text messages to reinforce study guidelines, answer any questions or concerns about their meal plans or supplements, and monitor for any potential adverse effects. Receives: Other: Placebo Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body Weight Measurement
Measured body weight did not change between baseline and experimental groups.
Measured: Along with the 40 days
Waist circumference
Measurement of waist circumference, that did not change statistically.
Measured: Along with the 40 days
Diastolic blood pressure
Measurement of diastolic blood pressure, that did not change statistically.
Measured: Along with the 40 days
Blood Glucose
Initial and final blood glucose only changed for the placebo group (p:0.008).
Measured: Along with the 40 days
Blood lipids profile
Initial and final values of blood lipids profile parameters for each group changed statistically (Experimental: Total cholesterol, HDL-c, LDL-cm VLDL-c, LDL/HDL-c ratio, and triglycerides; Placebo: HDL-c, LDL-c, and LDL/HDL-c ratio)
Measured: Along with the 40 days
Body Mass Index Measurement
Quantified body mass index did not change between baseline and experimental groups
Measured: Along with the 40 days]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2024
- Study start10 Jan 2023
- Primary completion31 Mar 2023
- Study completion30 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This clinical trial was a double-blind, randomized, placebo-controlled study conducted in the Nutrition department with the Clinical Analysis Laboratory at University of Monterrey. It aimed to evaluate ashwagandha's effect on serum lipid concentrations and body composition in Mexican adults with overweight and obesity. Eligible participants were adults with a BMI of 25 kg/m\^2 or higher, glucose levels around 100 mg/dL, LDL-C levels of 160 mg/dL or higher, total cholesterol levels of 200 mg/dL or higher, HDL-C levels lower than 40 mg/dL, and triglyceride levels exceeding 150 mg/dL. Participants provided informed consent per NOM-012-SSA3-2012 guidelines. They followed a prescribed dietary plan including 500 mg daily ashwagandha (Withania somnifera), authorized for use by the FDA. The supplementation period lasted 40 days. Participants were randomly assigned to the intervention group (W. somnifera, n=17) or placebo group (starch rice capsule/tablet, n=17).
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ivan Luzardo-Ocampo
- Sponsor type
- University, hospital or other
- Collaborators
- Tecnologico de Monterrey, Universidad Autonoma de Nuevo Leon
- Responsible party
- Sponsor-investigator, Ivan Luzardo-Ocampo, Universidad Autonoma de Queretaro
- Investigators
- Cindy Joanna Caballero-Prado, Ph. D., Principal investigator, Universidad Autonoma de Nuevo Leon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06676605
- Sponsor's protocol ID
- 202301
- Status last verified
- Nov 2024
- First submitted
- 1 Nov 2024
- Last updated
- 6 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data will be shared after reasonable request and under permission by Bioethics Committee Board
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Ashwagandha Pills Consumption in the Amelioration of Obesity-associated Parameters in Mexican Adults with Overweight and Obesity
- ClinicalTrials.gov ID
- NCT06676605
- Acronym / sponsor ID
- 202301
- Conditions
- Obesity, Overweight
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Ivan Luzardo-OcampoUniversity, hospital or other
- Collaborators
- Tecnologico de Monterrey, Universidad Autonoma de Nuevo Leon
- Study start
- 10 Jan 2023 (actual)
- Primary completion
- 31 Mar 2023 (actual)
- Study completion
- 30 Jan 2024 (actual)
- First posted
- 6 Nov 2024 (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 clinical trial aimed to assess the impact of ashwagandha supplementation on serum lipid concentrations and body composition in Mexican adults with overweight and obesity. It was a double-blind, placebo-controlled pilot study, including adult patients who consumed ashwagandha pills for 40 days after giving informed consent. Two groups were part of the study: an experimental group receiving the supplement and a placebo group. Measurements conducted included anthropometric parameters and blood biochemical parameters.
Detailed description
This clinical trial aimed to assess the impact of ashwagandha supplementation on serum lipid concentrations and body composition in Mexican adults with overweight and obesity through a double-blind, randomized, placebo-controlled protocol. The study included adult patients who met inclusion such as a Body Mass Index (BMI) of 25 kg/m^2 or higher, glucose levels around 100 mg/dL, LDL-C levels of 160 mg/dL or higher, total cholesterol levels of 200 mg/dL or higher, HDL-C levels lower than 40 mg/dL, and triglyceride levels exceeding 150 mg/dL). Patients were excluded if they were pregnant, had diabetes mellitus, hypertension, or hypersensitivity to Solanaceae products.
Volunteers signed an informed consent form as per NOM-012-SSA3-2012 guidelines, detailing the study's purpose and terms. Participants adhered to a prescribed dietary plan that included Ashwagandha (Withania somnifera) supplementation and consented to monitoring of their dietary intake and biochemical parameters measurement.
The ashwagandha supplementation involved 500 mg capsules taken daily for 40 days, with an intervention group (W. somnifera supplementation, 500 mg/day, n=17) and a placebo group (starch rice capsule/tablet/day, n=17). Both groups received personalized meal plans to ensure that observed changes were directly attributable to the supplements.
Anthropometric measurements included body weight, waist circumference, and BMI. Blood samples were extracted after 12 hours of fasting using a vacutainer system, and biochemical determinations were processed the same day with semi-automated equipment via COBAS® colorimetric methods. Parameters such as glucose, triglycerides, cholesterol, LDL-c, HDL-c, and VLDL-c were analyzed.
Sociodemographic data were described by gender, while clinical and anthropometric variables were categorized by intervention and control groups. Quantitative variables were compared using the student's t-test for related samples. Significant differences between baseline and experimental groups were found for total cholesterol, HDL, LDL, VLDL, the LDL/HDL-c ratio, and triglycerides.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This clinical trial was a double-blind, randomized, placebo-controlled study conducted in the Nutrition department with the Clinical Analysis Laboratory at University of Monterrey. It aimed to evaluate ashwagandha's effect on serum lipid concentrations and body composition in Mexican adults with overweight and obesity. Eligible participants were adults with a BMI of 25 kg/m^2 or higher, glucose levels around 100 mg/dL, LDL-C levels of 160 mg/dL or higher, total cholesterol levels of 200 mg/dL or higher, HDL-C levels lower than 40 mg/dL, and triglyceride levels exceeding 150 mg/dL. Participants provided informed consent per NOM-012-SSA3-2012 guidelines. They followed a prescribed dietary plan including 500 mg daily ashwagandha (Withania somnifera), authorized for use by the FDA. The supplementation period lasted 40 days. Participants were randomly assigned to the intervention group (W. somnifera, n=17) or placebo group (starch rice capsule/tablet, n=17).
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Dietary Supplement: Withania somniferaThe intervention group consisted of 17 participants who were administered a dietary supplement of Withania somnifera, classified as such and subject to FDA regulations comparable to pharmaceutical medications. Over a period of 40 days, participants in this group consumed 500 mg capsules of W. somnifera daily, in accordance with the manufacturer's instructions and within the recommended dose range of 240-600 mg. Prior to the supplementation period, comprehensive anthropometric and biochemical analyses were carried out to establish baseline measurements. Members of this group also received personalized meal plans to ensure that any observed changes were a direct result of the supplementation. Additionally, participants were closely monitored via email and/or text messages to remind them of study guidelines, address any questions or concerns, and watch for potential adverse effects. |
| Placebo Group | Placebo comparator | Other: Placebo InterventionThe placebo group also comprised 17 participants who were given a capsule/tablet of starch rice daily for the same 40-day period. Like the intervention group, participants in the placebo group underwent initial anthropometric and biochemical analyses to set baseline measurements before starting the supplementation period. This group similarly received personalized meal plans to ensure that any observed changes could be accurately attributed to the placebo effect. The placebo group participants were monitored via email and/or text messages to reinforce study guidelines, answer any questions or concerns about their meal plans or supplements, and monitor for any potential adverse effects. |
Who may qualify
- Ages
- 29 to 38 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Participants who are willing to comply with the study guidelines for a 40-day period.
- Individuals who consent to undergo initial anthropometric and biochemical analyses.
- Participants willing to follow personalized meal plans.
- Individuals who agree to receive reminders and monitoring communication via email and/or text messages.
Key exclusion criteria (4 listed)
- Individuals with known allergies or intolerances to Withania somnifera or starch rice.
- Participants who are unable or unwilling to follow the daily supplementation regimen.
- Individuals with medical conditions that might interfere with the study results or pose a health risk when taking the supplement.
- Participants currently taking any other supplements or medications that could interfere with the study outcomes.
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 |
|---|---|---|
| Withania somniferaAlso: AshwagandhaThe experimental supplement administered to patients in this study was Withania somnifera, commonly known as ashwagandha. It is classified as a dietary supplement and is regulated similarly to pharmaceutical medications. The supplement has been authorized for commercialization and use by the Food and Drug Administration (FDA). Participants received the supplement in the form of 500 mg capsules, taken daily over a 40-day period, following the manufacturer's instructions. The range of the recommended daily dose is between 240 and 600 mg. The purpose of administering this supplement was to evaluate its impact on various health parameters, including serum lipid concentrations and body composition, in the study's participants. | Dietary supplement | Intervention Group |
| Placebo InterventionAlso: PillsThe product administered to the placebo group was designed to simulate the appearance and administration of the experimental supplement but without containing any active ingredients. Participants in the placebo group received capsules/tablets filled with starch rice. These capsules were taken daily over the same 40-day period as the experimental group, ensuring that the placebo group followed identical administration and monitoring procedures. The use of starch rice capsules aimed to serve as a neutral control, allowing for a comparison between the effects of the actual Withania somnifera supplement and the placebo. | Other | Placebo Group |
Primary outcome
Body Weight Measurement
Time frame: Along with the 40 days
Measured body weight did not change between baseline and experimental groups.
Waist circumference
Time frame: Along with the 40 days
Measurement of waist circumference, that did not change statistically.
Diastolic blood pressure
Time frame: Along with the 40 days
Measurement of diastolic blood pressure, that did not change statistically.
Blood Glucose
Time frame: Along with the 40 days
Initial and final blood glucose only changed for the placebo group (p:0.008).
Blood lipids profile
Time frame: Along with the 40 days
Initial and final values of blood lipids profile parameters for each group changed statistically (Experimental: Total cholesterol, HDL-c, LDL-cm VLDL-c, LDL/HDL-c ratio, and triglycerides; Placebo: HDL-c, LDL-c, and LDL/HDL-c ratio)
Body Mass Index Measurement
Time frame: Along with the 40 days]
Quantified body mass index did not change between baseline and experimental groups
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2024.
- Individual participant dataSharing planned: No. Data will be shared after reasonable request and under permission by Bioethics Committee Board
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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.
Cindy Joanna Caballero-Prado, Ph. D. principal investigator
Universidad Autonoma de Nuevo Leon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Withania somnifera in people with Obesity and Overweight, run by Ivan Luzardo-Ocampo 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 4 inclusion and 4 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: finished, as of the sponsor's last update on 6 Nov 2024. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Body Weight Measurement (time frame: Along with the 40 days). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Nov 2024.