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Randomized controlled trial to examine efficacy on body fat reduction and safety of amino acid mixture during physical activity promotion in overweight adults

Phase 3
Conditions
Overweight
Registration Number
JPRN-UMIN000025186
Lead Sponsor
KSO Corporation
Brief Summary

A-mix supplementation in combination with physical activity promotion facilitated abdominal fat reduction in overweight adults.

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete: follow-up complete
Sex
All
Target Recruitment
200
Inclusion Criteria

Not provided

Exclusion Criteria

1. Constant use of oral medication potentially affecting body weight and lipid metabolism 2. Those who have severe hepatic disorder, cardiovascular disorder, breathing disorder, endocrine disorder, metabolism disorder, or food allergy 3. Those who cannot stop use of health food products or supplements potentially affecting body weight and lipid metabolism 4. Current or past history of drug or alcohol dependence 5. Those who cannot abstain from alcohol drinking for 2 days before measurements 6. Those who have some metal implanted in their abdominal site 7. With cardiac pacemaker or implanted defibrillator 8. Diagnosed with phenylketonuria or hyperphenylalaninemia 9. Diagnosed with familial hyperlipidemia 10. Those who are currently pregnant or nursing or desire pregnancy during the study 11. Those who have extremely irregular dietary habits or lifecycle such as midnight work 12. Those who participate or are willing to participate clinical trials of other food products, drugs, or beauty products. 13. Those who have claustrophobia 14. Those who are judged as unsuitable for the study by the principal investigator for other reasons

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
3-month changes in abdominal fat areas
Secondary Outcome Measures
NameTimeMethod
3-month changes in body weight, percent body fat, waist circumference, hip circumference, waist-hip ratio, blood pressure, BMI, triglyceride, total cholesterol, high-density lipoprotein cholesterol, low-density lipoprotein cholesterol, fasting plasma glucose, HbA1c, insulin, and HOMA-R
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