Effect of Metabolaid® on AMPK Activation for Weight Loss
Anti-obesity Effects of Metabolaid® With AMPK-activating Capacity in Overweight Subjects: A Randomized Controlled Trial
1 other identifier
interventional
46
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Mar 2015
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2015
CompletedFirst Submitted
Initial submission to the registry
May 30, 2018
CompletedFirst Posted
Study publicly available on registry
June 26, 2018
CompletedJune 27, 2018
June 1, 2018
4 months
May 30, 2018
June 25, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Changes in body Weight, using a weight scale
In Kg
At the beginning, four weeks and end of the intervention, total eight weeks.
Secondary Outcomes (10)
Height, using measuring tape
At the beginning, four weeks and eight weeks
BMI, calculated based on Weight and Height
At the beginning, four weeks and eight weeks
Waist Circumference, using a measuring tape
At the beginning, four weeks and eight weeks
Glucose
At the beginning, four weeks and eight weeks
Tryglicerides
At the beginning, four weeks and eight weeks
- +5 more secondary outcomes
Study Arms (2)
Placebo Control
PLACEBO COMPARATOR2 capsules per day, each with 400 mg Cellulose microcrystalline, for 8 weeks
Dietetic Supplement Group
EXPERIMENTAL2 Capsules per day of Metabolaid® (each capsule contains 250 mg Metabolaid®, 150 mg cellulose microcrystalline), for 8 weeks
Interventions
Eligibility Criteria
You may qualify if:
- Participants with a body mass index (BMI) from 24 to 34 kg/m2
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Universidad Miguel Hernandez de Elchelead
- Monteloeder SLcollaborator
Study Sites (1)
Universidad Miguel Hernandez de Elche
Elche, Alicante, 03202, Spain
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, CARE PROVIDER
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
May 30, 2018
First Posted
June 26, 2018
Study Start
March 1, 2015
Primary Completion
July 1, 2015
Study Completion
July 1, 2015
Last Updated
June 27, 2018
Record last verified: 2018-06
Data Sharing
- IPD Sharing
- Will not share