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Impact of Ashwagandha in Obesity Parameters from Mexican Adults

NCT06676605 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2024-11-06

No results posted yet for this study

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

Interventions

DIETARY_SUPPLEMENT

Withania somnifera

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.

OTHER

Placebo Intervention

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.

Sponsors & Collaborators

  • Tecnologico de Monterrey

    collaborator OTHER

  • Universidad Autonoma de Nuevo Leon

    collaborator OTHER

  • Ivan Luzardo-Ocampo

    lead OTHER

Principal Investigators

  • Cindy Joanna Caballero-Prado, Ph. D. · Universidad Autonoma de Nuevo Leon

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
29 Years
Max Age
38 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-01-10
Primary Completion
2023-03-31
Completion
2024-01-30

Countries

  • Mexico

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06676605 on ClinicalTrials.gov