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临床试验/NCT05906771
NCT05906771已完成不适用

Study of the Effect of the Combined Extract of Lemon Verbena and Hibiscus on Health Indicators

University of Alicante1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2023年7月1日最近更新:
适应症
干预措施

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

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

Placebo Comparator

Nutraceutical placebo intake group

干预措施: Nutraceutical placebo (Dietary Supplement)

EXPERIMENTAL GROUP

Experimental

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Prof. Dr. Alejandro Martínez-Rodríguez

Full Professor

University of Alicante

研究点 (1)

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