Clinical trial NCT06676605: Impact of Ashwagandha in Obesity Parameters from Mexican Adults
Official title: Assessment of Ashwagandha Pills Consumption in the Amelioration of Obesity-associated Parameters in Mexican Adults with Overweight and Obesity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Overweight
Lead sponsor: Universidad Autonoma de Queretaro
Sponsor class: OTHER
Collaborators: name: Tecnologico de Monterrey
name: Universidad Autonoma de Nuevo Leon
First posted: 2024-11-06
Enrollment: 34
Sex: ALL
Minimum age (years): 29
Maximum age (years): 38
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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).
Primary purpose: TREATMENT

Brief 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 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.

Eligibility criteria: Inclusion Criteria:

1. Participants who are willing to comply with the study guidelines for a 40-day period.
2. Individuals who consent to undergo initial anthropometric and biochemical analyses.
3. Participants willing to follow personalized meal plans.
4. Individuals who agree to receive reminders and monitoring communication via email and/or text messages.

Exclusion Criteria:

1. Individuals with known allergies or intolerances to Withania somnifera or starch rice.
2. Participants who are unable or unwilling to follow the daily supplementation regimen.
3. Individuals with medical conditions that might interfere with the study results or pose a health risk when taking the supplement.
4. Participants currently taking any other supplements or medications that could interfere with the study outcomes.

Primary outcomes:
measure: Body Weight Measurement
timeFrame: Along with the 40 days
measure: Waist circumference
timeFrame: Along with the 40 days
measure: Diastolic blood pressure
timeFrame: Along with the 40 days
measure: Blood Glucose
timeFrame: Along with the 40 days
measure: Blood lipids profile
timeFrame: Along with the 40 days
measure: Body Mass Index Measurement
timeFrame: Along with the 40 days]
Secondary outcomes:
Other outcomes:
Locations:
city: Monterrey
country: Mexico
facility: Nutrition Department at Universidad Autonoma de Nuevo Leon
state: Nuevo Leon
Study officials:
affiliation: Universidad Autonoma de Nuevo Leon
name: Cindy Joanna Caballero-Prado, Ph. D.
role: PRINCIPAL_INVESTIGATOR
References: