Effect of Metabolaid® on AMPK Activation for Weight Loss
- Conditions
- Metabolic Syndrome
- Interventions
- Dietary Supplement: Metabolaid®Dietary Supplement: Placebo
- Registration Number
- NCT03568877
- Lead Sponsor
- Universidad Miguel Hernandez de Elche
- Brief Summary
The objective of this study was to establish a formulation, containing both Hibiscus sabdariffa L. (HS) and Lippia citriodora L. (LC) extracts (Metabolaid®) that had significant capacity to activate the AMPK-enzyme and to reduce triglyceride accumulation in the hypertrophied adipocyte model. Then, we assessed the efficacy of this combination in light-to-moderate-overweight subjects under risk of developing metabolic syndrome.
- Detailed Description
AMP-activated protein kinase (AMPK) has been postulated as a molecular target in the amelioration of obesity-related diseases, where most therapeutic approaches have failed. Plant-polyphenols have shown the capacity to ameliorate obesity-induced metabolic disturbances. A combination of polyphenols (LC-HS) derived from Hibiscus sabdariffa L. (HS) and Lippia citriodora L. (LC) (lemon verbena) (Metabolaid®) was assessed for triglyceride accumulation and AMPK activation in the hypertrophied adipocyte model 3T3-L1. A dietary supplement containing 500 mg of LC-HS was evaluated in a double blind, placebo-controlled and randomized trial in 56 overweight subjects for two months. Anthropometric and circulating biochemical parameters were determined.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 46
- Participants with a body mass index (BMI) from 24 to 34 kg/m2
- total cholesterol lower than 200 mg/dL.
- use of prescription medication for cholesterol or hypertension.
- presence of any obesity-related pathology.
- hormone replacement therapy.
- consumption of antioxidant supplements/drugs.
- alcohol addiction.
- women who were pregnant or lactating.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Dietetic Supplement Group Metabolaid® 2 Capsules per day of Metabolaid® (each capsule contains 250 mg Metabolaid®, 150 mg cellulose microcrystalline), for 8 weeks Placebo Control Placebo 2 capsules per day, each with 400 mg Cellulose microcrystalline, for 8 weeks
- Primary Outcome Measures
Name Time Method Changes in body Weight, using a weight scale At the beginning, four weeks and end of the intervention, total eight weeks. In Kg
- Secondary Outcome Measures
Name Time Method HDL Cholesterol At the beginning, four weeks and eight weeks Blood Sampling in Fasting conditions, in mg/dl
Total Cholesterol At the beginning, four weeks and eight weeks Blood Sampling in Fasting conditions, in mg/dl
Blood Pressure At the beginning, four weeks and eight weeks Single Blood Pressure measurements, using the Omron M6 Comfort device
Heart rate At the beginning, four weeks and eight weeks Single Blood Pressure measurements, using the Omron M6 Comfort device
Height, using measuring tape At the beginning, four weeks and eight weeks In cm
BMI, calculated based on Weight and Height At the beginning, four weeks and eight weeks in kg/m\^2
Waist Circumference, using a measuring tape At the beginning, four weeks and eight weeks in kg/m\^2
Glucose At the beginning, four weeks and eight weeks Blood Sampling in Fasting conditions, in mg/dl
Tryglicerides At the beginning, four weeks and eight weeks Blood Sampling in Fasting conditions, in mg/dl
LDL Cholesterol At the beginning, four weeks and eight weeks Blood Sampling in Fasting conditions, in mg/dl
Trial Locations
- Locations (1)
Universidad Miguel Hernandez de Elche
🇪🇸Elche, Alicante, Spain