Assessment of Ashwagandha Pills Consumption in the Amelioration of Obesity-associated Parameters in Mexican Adults with Overweight and Obesity
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- Body Weight Measurement
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 29 Years 至 38 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Placebo Group
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.
干预措施: Placebo Intervention (Other)
Intervention Group
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.
干预措施: Withania somnifera (Dietary Supplement)
结局指标
主要结局
Body Weight Measurement
时间窗: Along with the 40 days
Measured body weight did not change between baseline and experimental groups.
Waist circumference
时间窗: Along with the 40 days
Measurement of waist circumference, that did not change statistically.
Diastolic blood pressure
时间窗: Along with the 40 days
Measurement of diastolic blood pressure, that did not change statistically.
Blood Glucose
时间窗: Along with the 40 days
Initial and final blood glucose only changed for the placebo group (p:0.008).
Blood lipids profile
时间窗: 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
时间窗: Along with the 40 days]
Quantified body mass index did not change between baseline and experimental groups
次要结局
未报告次要终点
研究者
Ivan Luzardo-Ocampo
Professor Researcher
Universidad Autonoma de Queretaro