Clinical trial NCT03568877: Effect of Metabolaid® on AMPK Activation for Weight Loss
Official title: Anti-obesity Effects of Metabolaid® With AMPK-activating Capacity in Overweight Subjects: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Metabolic Syndrome
Lead sponsor: Universidad Miguel Hernandez de Elche
Sponsor class: OTHER
Collaborators: name: Monteloeder SL
First posted: 2018-06-26
Enrollment: 46
Sex: FEMALE
Minimum age (years): 36
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: Inclusion Criteria:

* Participants with a body mass index (BMI) from 24 to 34 kg/m2

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Changes in body Weight, using a weight scale
timeFrame: At the beginning, four weeks and end of the intervention, total eight weeks.
Secondary outcomes:
measure: Height, using measuring tape
timeFrame: At the beginning, four weeks and eight weeks
measure: BMI, calculated based on Weight and Height
timeFrame: At the beginning, four weeks and eight weeks
measure: Waist Circumference, using a measuring tape
timeFrame: At the beginning, four weeks and eight weeks
measure: Glucose
timeFrame: At the beginning, four weeks and eight weeks
measure: Tryglicerides
timeFrame: At the beginning, four weeks and eight weeks
measure: LDL Cholesterol
timeFrame: At the beginning, four weeks and eight weeks
measure: HDL Cholesterol
timeFrame: At the beginning, four weeks and eight weeks
measure: Total Cholesterol
timeFrame: At the beginning, four weeks and eight weeks
measure: Blood Pressure
timeFrame: At the beginning, four weeks and eight weeks
measure: Heart rate
timeFrame: At the beginning, four weeks and eight weeks
Other outcomes:
Locations:
city: Elche
country: Spain
facility: Universidad Miguel Hernandez de Elche
state: Alicante
Study officials:
References: