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Effects of Irvingia gabonensis kernel extract on fat oxidation rate, body mass, metabolism, oxidative stress, inflammation, and aerobic capacity in overweight or obese individuals

Phase 2
Recruiting
Conditions
Overweight and obese individuals which has BMI more than 30 kg/m2 up to 29.9 kg/m2.
overweight
obese
Registration Number
TCTR20200803005
Lead Sponsor
Blacmores company
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
All
Target Recruitment
72
Inclusion Criteria

1)Men or women age between 30 and 59 years old
2)BMI range between 23 and 29.9 kg/m2
3)Stable weight (within four kilograms changed) at least three months before the supplementation phase
4)Consistency of regular medicine such as hypertension and dyslipidemia drugs
5)SGPT and creatinine levels less than 35 IU/L and 1 mg/dL respectively
6)No attempt to reduce weight at least three months before the randomization
7)Not taking any supplementation at least three months before the randomization.
8)Non-smoker and alcohol drinker

Exclusion Criteria

1)Pregnancy
2)Diagnosed with type 2 diabetes mellitus (fasting blood glucose > 126 mg/dL)
3)Diagnosed with cardiovascular diseases except hypertension
4)Cannot maintain regular medicines
5)Diagnosed with neuromuscular disease
6)Diagnosed with orthopedic problems and history of bone fracture
7)Diagnosed with liver and kidney diseases
8)Diagnosed with autonomic neuropathy
9)Chronic infections (HIV, TB, Hepatitis)
10)Diagnosed with endocrine diseases, thyroid conditions, polycystic ovary syndrome (PCOS)
11)Had history with drug or natural ingredients allergy which was contained in the tablet

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Fat oxidation rate day 91, 175 indirect calorimetry
Secondary Outcome Measures
NameTimeMethod
CHO oxidation rate day 91, 175 indirect calorimetry,Adiposity day 91, 112, 133, 175 Dual-energy X-ray absorptiometry (DXA),Resting metabolic rate day 91, 175 indirect calorimetry,Lipid profiles day 1, 91, 112, 133, 175 Refloton Plus, U.S.,Plasma malondialdehyde day 91, 112, 133, 175 Depler method,Plasma vitamin c day 91, 112, 133, 175 Zhang's method,hs-CRP day 91, 112, 133, 175 Cobas,Adiponectin 4 times human adiponectin enzyme immunoassay kit (Cayman, USA),Leptin day 91, 112, 133, 175 human leptin enzyme immunoassay kit (Cayman, USA),Liver and kidney function day 91, 112, 133, 175 Refloton Plus, U.S.,Exercise capacity day 91, 175 ergometer,Telomere length day 91, 175 RT-PCR
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