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A randomized, placebo-controlled study on efficacy and safety of combinational administration of mangosteen pericarps extracts and lychee fruit pericarps extracts in patients with metabolic syndrome

A randomized, placebo-controlled study on efficacy and safety of combinational administration of mangosteen pericarps extracts and lychee fruit pericarps extracts in patients with metabolic syndrome - Efficacy and safety of the combinational administration of mangosteen pericarps extracts and lychee fruit pericarps extracts for metabolic syndrome

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000014525
Enrollment
60
Registered
2014-07-31
Start date
2012-08-17
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metabolic syndrome

Interventions

Ingestion of placebo capsules for 12 consecutive week Ingestion of capsules include extract of pericarp of mangosteen and extract of lychee for 12 consecutive weeks Ingestion of capsules include extr

Sponsors

Total Technological Consultant Co., Ltd.(TTC)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Japanese males and females between the ages of 35 and 65 2. abdominal circumference greater or equal 85cm in males and 90 cm in female on preliminary examination 3. applicable to more than two of three following indexes on preliminary examination; blood pressure greater or equal 130/85 mm Hg, triglycerides greater or equal 150mg/dL or serum high-density lipoprotein cholesterol (HDL-C) less 40 mg/dL, blood glucose greater or equal 110 mg/dL, body weight less100 kg, or body mass index greater or equal 25 kg/m2

Exclusion criteria

Exclusion criteria: 1. having exercise or diets for reducing body weight 2. having the medicines or dietary supplements affecting body fat, serum triglyceride, or lipid metabolism potentially 3. having foods fortified with mangosteen or lychee extracts 4. with severe abnormalities of blood pressure or blood test 5. excessive habitual smoker or alcohol addict or extremely irregular food habits person 6. with severe disease receiving treatment 7. needing emergent treatment to diabetes, hepatopathy, renal or heart disease 8. having possibilities of emerging allergy related to the study 9. with pregnant (including with pregnant in plan), or in the lactation period 10. judged to be inadequate by the questionnaire of lifestyles 11. judged to be inadequate by biochemical assessment in blood on preliminary examination 12. taking part in other clinical trials within a month from the initiation of this clinical trial 13. judged to be inadequate by the doctors responsible for this clinical study.

Design outcomes

Primary

MeasureTime frame
Visceral fat area, body weight(body mass index), abdominal circumstance, blood pressure, triglyceride, HDL-cholesterol, blood glucose

Secondary

MeasureTime frame
Subcutaneous fat area, total fat area, adiponectin, HMW adiponectin, leptin, adiponectin/ leptin, HMW adiponectin/ total adiponectin, HMW adiponectin/ leptin, questionnaire

Countries

Japan

Contacts

Public ContactMuneaki Iizuka

Total Technological Consultant Co., Ltd.(TTC) Clinical Research Planning Dept.

m.iizuka@ttc-tokyo.co.jp03-5459-5329

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026