A study to evaluate the efficacy of D-Ppsicose on weight reduction in overweight subjects

A randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of D-Ppsicose on weight or body fat reduction in overweight or obese subjects

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CRIS

Registry ID

KCT0002081

Enrollment

Registered

2016-09-29

Start date

2014-11-05

Completion date

Unknown

Last updated

2019-03-11

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

Conditions

None listed

Interventions

Dietary Supplement : Study drugs and placebo were administered as powder that were identical in size and appearance. The test substance used in this study was 6 g of D-psicose packaged in aluminum foi

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - 99 overweight or obese patients (body mass index [BMI] between 23 kg/m2 and 30 kg/m2 ) aged between 19 and 65 years - For women of childbearing age , negative pregnancy test during screening - individuals agreed to participate in the study voluntarily after sufficient explanation regarding the purpose and content of study

Exclusion criteria

Exclusion criteria: The exclusion criteria included (1) Current or past history of any malignant diseases during the past 5 years ; (2) hypersensitivity to D-psicose; (3) Current psychiatric illness or psychotropic medication; (4) History of participation in any weight loss program 3 months before screening; (5) Pregnancy or breast feeding; (6) weight stable (±5%) for 3 months prior to their study participation; 7) Current use of drug that can affect the weight (weight-loss drugs, Dietary Supplements, oral corticosteroid, thyroid hormon, cyproheptadine, phenothiazine, oral contraceptive; (8) abnormal renal function or hepatic function test: and (9) The presence of diabetes or unstable cardiovascular disease.

Design outcomes

Primary

Measure	Time frame
body fat mass change	—

Secondary

Measure	Time frame
visceral and liver fat assessed by CT;Waist circumference;body mass index (BMI, kg/m2) and body weight;cardiovascular risk factors: fasting lipid concentrations (total cholesterol, highdensity lipoprotein [HDL] cholesterol, low-density lipoprotein [LDL] cholesterol, and triglycerides [TG]), glucose, insulin, and C-reactive protein;adverse events and safety	—

Countries

Korea, Republic of

Contacts

Public Contactsehong Kim

The Catholic University of Korea

iron1600@naver.com

Outcome results