Impact of Ashwagandha in Obesity Parameters from Mexican Adults

NCT06676605 | Completed

• 1 other identifier: 202301
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity; Overweight

Outcome Measures

Primary Outcomes (6)

• Body Weight Measurement

  Measured body weight did not change between baseline and experimental groups.

  Along with the 40 days

• Waist circumference

  Measurement of waist circumference, that did not change statistically.

  Along with the 40 days

• Diastolic blood pressure

  Measurement of diastolic blood pressure, that did not change statistically.

  Along with the 40 days

• Blood Glucose

  Initial and final blood glucose only changed for the placebo group (p:0.008).

  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)

  Along with the 40 days

• Body Mass Index Measurement

  Quantified body mass index did not change between baseline and experimental groups

  Along with the 40 days]

Study Arms (2)

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.

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.

Other: Placebo Intervention

Interventions

Withania somnifera DIETARY_SUPPLEMENT

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.

Also known as: Ashwagandha

Intervention Group

Placebo Intervention OTHER

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.

Also known as: Pills

Placebo Group

Eligibility Criteria

• Age: 29 Years - 38 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ivan Luzardo-Ocampo: lead
• Tecnologico de Monterrey: collaborator
• Universidad Autonoma de Nuevo Leon: collaborator

Study Sites (1)

Nutrition Department at Universidad Autonoma de Nuevo Leon

Monterrey, Nuevo León, 66238, Mexico

Location

MeSH Terms

Conditions

Obesity; Overweight

Interventions

Ashwagandha

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Cindy Joanna Caballero-Prado, Ph. D.

  Universidad Autonoma de Nuevo Leon

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: In this double-blind study, rigorous masking procedures were implemented to ensure the integrity of the results. None of the participants knew or met each other, and they had no prior information about the researcher conducting the study. Participants were instructed not to discuss their experiences, feelings, or outcomes with each other throughout the study duration. Furthermore, the researchers who processed the data were blinded to the participants' identities; they only analyzed the biochemical and anthropometric parameters without knowing which patient each set of data belonged to or any personal background information. This ensured that the analysis remained unbiased and confidential.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor Researcher

Model Details: 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).

Study Record Dates

• First Submitted: November 1, 2024
• First Posted: November 6, 2024
• Study Start: January 10, 2023
• Primary Completion: March 31, 2023
• Study Completion: January 30, 2024
• Last Updated: November 6, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)