Antioxidant Effect, Body Composition, Body Weight, Cardiovascular Diseases, Densitometry, Diet, Mediterranean
Conditions
Brief summary
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.
Interventions
DIETARY_SUPPLEMENTMetabolaid(R)
The participating subjects will have to follow the intake of the nutraceutical for 3 months, as well as attend the stipulated visits. Participants will be given a register to control their daily intake of the nutraceutical. They should not change their daily habits. The nutraceutical has been elaborated by Monteloeder, S.L. It is a combination of Hibiscus sabdariffa flowers and Lippia citriodora leaves. The dose that the participants of the experimental group will receive will be 300mg plus 20mg of microcrystalline cellulose. The product is presented in an unflavored capsule, it is a reddish-brown powder with a characteristic odor and a slightly bitter taste. The manufacturing date of the product was 01/12/2022 and the expiration date was 30/11/2024.
DIETARY_SUPPLEMENTNutraceutical placebo
The participating subjects will have to follow the intake of the nutraceutical for 3 months, as well as attend the stipulated visits. Participants will be given a register to control their daily intake of the nutraceutical. They should not change their daily habits. Nutraceutical placebo contains microcystalline cellulose (185mg) and maltodextrin (185mg).
Sponsors
University of Alicante
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| WEIGHT | 12 weeks | The weight of the subjects will be obtained using the TANITA (Tokyo, Japan). |
| HEIGHT | 12 weeks | The height of the subjects will be measured with the SECA 123 stadiometer (Hamburg, Germany). |
| BLOOD PREASURE | 12 weeks | Measurement of blood pressure (systolic and diastolic) with a digital tensiometer. |
| FAT MASS | 12 weeks | Assessment of body composition by DXA and bioimpedance to obtain fat mass results. |
| HEART RATE | 12 weeks | Measurement of heart rate with a digital tensiometer. |
| SATIETY | 12 weeks | Scores will be obtained through validated questionnaires for the study of satiety of the participating subjects. |
| BLOOD CHOLESTEROL LEVEL | 12 weeks | Cholesterol blood values will be obtained using the flexible and portable accutrend® plus |
| TRIGLICERIDES | 12 weeks | Triglicerides blood values will be obtained using the flexible and portable accutrend® plus |
| BLOOD GLUCOSE LEVEL | 12 weeks | Glucose blood values will be obtained using the flexible and portable accutrend® plus |
Countries
Spain
Outcome results
None listed