Study of the Effect of the Combined Extract of Lemon Verbena and Hibiscus on Health Indicators
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- WEIGHT
研究概览
简要总结
Plant polyphenols have demonstrated the ability to ameliorate metabolic alterations induced by overweight and obesity, both in cellular and animal models, where most therapeutic approaches have failed. These have demonstrated the ability to improve appetite sensation, leading to improved body weight control, in addition to reducing fat accumulation and improving plasma glycemic and lipid profiles, as well as inflammatory process and vascular dysfunction. The plant polyphenols on which the extract to be studied will be based will be hibiscus and lemon verbena. A randomized controlled trial will be carried out in overweight or obese subjects from the province of Alicante. An electronic randomization will be carried out based on a two-branch design, therefore, there will be a control group (no intervention) and an experimental group (nutraceutical intake). Participants will have to ingest the nutraceutical for 3 months, as well as attend the agreed visits. Different satiety questionnaires, circulating parameters measured in capillaries (cholesterol, triglycerides and glucose), blood pressure and body composition measured by bone densitometry (DXA) will be collected. All variables will be measured at 4 different time points (baseline, 30 days, 60 days and 90 days). All these will be analyzed as a function of time; at the beginning and end of each intervention (intra-group analysis), as well as comparing the control group with the experimental group (inter-group analysis). A multidisciplinary team formed by physicians, nurses and nutritionists will be involved.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Elderly (< 18 years)
- •Overweight (body mass index 25-29.9 kg/m2)
排除标准
- •Pregnant or lactating subjects
- •Who have participated in another study with similar characteristics in the last 3 months.
- •Subjects with pathologies.
- •Consumption of drugs and/or supplements
- •Subjects with food intolerances/allergies.
- •Subjects with muscle or joint injury.
- •Subjects with impossibility to follow up the intervention.
- •Refusal of informed consent
研究组 & 干预措施
CONTROL GROUP
Nutraceutical placebo intake group
干预措施: Nutraceutical placebo (Dietary Supplement)
EXPERIMENTAL GROUP
Intake of natural herbal dietary supplement composed of a combination of Hibiscus sabdariffa flowers and Lippia citriodora leaves.
干预措施: Metabolaid(R) (Dietary Supplement)
结局指标
主要结局
WEIGHT
时间窗: 12 weeks
The weight of the subjects will be obtained using the TANITA (Tokyo, Japan).
HEIGHT
时间窗: 12 weeks
The height of the subjects will be measured with the SECA 123 stadiometer (Hamburg, Germany).
HEART RATE
时间窗: 12 weeks
Measurement of heart rate with a digital tensiometer.
BLOOD PREASURE
时间窗: 12 weeks
Measurement of blood pressure (systolic and diastolic) with a digital tensiometer.
FAT MASS
时间窗: 12 weeks
Assessment of body composition by DXA and bioimpedance to obtain fat mass results.
TRIGLICERIDES
时间窗: 12 weeks
Triglicerides blood values will be obtained using the flexible and portable accutrend® plus
BLOOD GLUCOSE LEVEL
时间窗: 12 weeks
Glucose blood values will be obtained using the flexible and portable accutrend® plus
SATIETY
时间窗: 12 weeks
Scores will be obtained through validated questionnaires for the study of satiety of the participating subjects.
BLOOD CHOLESTEROL LEVEL
时间窗: 12 weeks
Cholesterol blood values will be obtained using the flexible and portable accutrend® plus
次要结局
未报告次要终点
研究者
Prof. Dr. Alejandro Martínez-Rodríguez
Full Professor
University of Alicante
