Skip to content

The Efficacy and Safety of Phaeodactylum tricornutum extract on reducing body weight and body fat of overweight or obesity subjects

Efficacy and Safety of Phaeodactylum tricornutum extract on reducing body weight and body fat of overweight or obesity subjects; A 12 week, Randomized, Double-blind, Placebo-Controlled Clinical Trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CRIS
Registry ID
KCT0003979
Enrollment
100
Registered
2019-05-23
Start date
2018-11-28
Completion date
Unknown
Last updated
2019-06-17

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 : Subjects will be randomized to receive Phaeodactylum tricornutum or Placebo. Subjects will take 1 capsule once a day for 12weeks.

Sponsors

H Plus Yangji Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Subjects between 20 ~65 years of age 2) BMI of 25.0-31.9 kg/m2 3) Subjects who agree the particpation in the trial and submit informed and consent before the beginning of the trial.

Exclusion criteria

Exclusion criteria: 1) The Patients with severe cerebrovascular disease, cardiac disease (If that patient's clinical status is stable, they can participate in the clinical trial according to investgator) within recent 6 months. 2) Subejects who have taken drugs such as absorption inhibitors and apetite suppressants, health functional foods/supplements related to obesity improvement, psychiatric drugs such as drpression, beta blockers, diuetics, birth control pills, steroids, female hormone within recent a month. 3) Subjects with systolicBP = 160 mmHg or diastolicBP = 100 mmHg(Subjects measure after 10 minutes stabilization) 4) Subjects with diabetes(use of hypoglycemic agent or insulin)or fasting blood glucose = 126 mg/dL or random blood glucose = 200 mg/dL. 5) Subjects with TSH = 0.1 µU/ml or TSH = 10 µU/ml. 6) Creatinine is more than twice the normal upper limit 7) AST(GOT) or ALT(GPT) is more than three times the normal upper limit 8) Subjects who have difficulty in taking test materials because of the severe gastrointestinal disturbances 9) Subjects who are admitted to hospital, medication or rehabilitation due to alcohol, heart disese, central nervous disorder 10) Those who are judged to be unable to exercise due to musculoskeletal disorders 11) Subjects who loss weight wihtin recent a month 12) Those who participated in the commercial obesity program within the last 3 months 13) Those who participated or will participate in other clinical trials within the past month. 14) A person who is pregnant or who has a pregnancy plan during the period of the test 15) Those who are sensitive or allergic to foods related to green algae, microalgae and brown algae. 16) Subjects which in the opinion investigator could affect preclude evluation of response

Design outcomes

Primary

MeasureTime frame
Body fat percentage, fat mass through DEXA

Secondary

MeasureTime frame
Body weight;waist circumference, hip circumference, waist/hip circumference ratio;body mass index;Fat content through DEXA;Total cholesterol, HDL-cholesterol, LDL-cholesterol, triglyceride, Adiponectin, Leptin, hs-CRP;Visceral fat area, subcutaneous fat area, total abdominal fat area, visceral/subcutaneous fat area through CT

Countries

Korea, Republic of

Contacts

Public ContactKang seung hyun

H Plus Yangji Hospital

juspa@naver.com+82-70-4665-9490

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Feb 4, 2026