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

University of Alicante

Status: Completed

Conditions: Antioxidant Effect; Diet, Mediterranean; Cardiovascular Diseases; Densitometry; Body Weight; Body Composition

Treatments: Dietary Supplement: Nutraceutical placebo; Dietary Supplement: Metabolaid(R)

Study type: Interventional

Funder types: Other

Identifiers

NCT05906771

UA-2023-05-08

Details and patient eligibility

About

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.

Enrollment: 60 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Elderly (< 18 years)
• Overweight (body mass index 25-29.9 kg/m2)

Exclusion criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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60 participants in 2 patient groups, including a placebo group

CONTROL GROUP

Placebo Comparator group

Description:

Nutraceutical placebo intake group

Treatment:

Dietary Supplement: Nutraceutical placebo

EXPERIMENTAL GROUP

Experimental group

Description:

Intake of natural herbal dietary supplement composed of a combination of Hibiscus sabdariffa flowers and Lippia citriodora leaves.

Treatment:

Dietary Supplement: Metabolaid(R)