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A human study to evaluate effectiveness of Solidago virgaurea extraction

A human study to evaluate effectiveness of Solidago virgaurea extraction on body fat level and related metabolism in obese adults : a randomized, double-blind, parallel, placebo-controlled study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CRIS
Registry ID
KCT0002027
Enrollment
80
Registered
2016-08-26
Start date
2016-10-04
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 material: Capsule that contains the extract of Solidago virgaurea subsp. Gigantea Taking 2 capsules/time, 3 times/ day with sufficient water.duration: 1

Sponsors

Hallym University Medical Center- Chuncheon
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Subject who voluntarily agree to participate and signs informed consent form 2) 20 years= Age <65 years 3) 25kg/m2= body mass index> < 30kg/m2 4) 90 cm (male), 85 cm (female) = Waist circumference 5) Subject who can comply with dietary/exercise guidelines for intervention period

Exclusion criteria

Exclusion criteria: 1) Administration of medicine that affect body weight, metabolism of blood glucose, inflammatory response within 6 weeks of first visit. : Appetite suppressants/accelerators, diuretics, beta-blocker, contraceptive, steroid drug, tricyclic antidepressant, postmenopausal hormone medicine, laxatives, antidepressant, anti-inflammatory agent et al 2) Experience of commercial obesity program or calorie-restricted therapy within three months before the first visit 3) Consistent consumption of dietary supplements, oriental medicine or drug for body weight control or medication related with hepatic cirrhosis or hepatitis within one month before the first visit. 4) Subject with change of body weight more than 3kg within three months before the first visit 5) Subject with experience of Gastroplasty or intestinal resection for management body weight 6) Subject with experience of severe depression (in case of hospitalization or suicidal attempt) 7) Subject with experience of epilepsy or eating disorder 8) Subject with following diseases: ? Hypertension (Systolic blood pressure=140 mmHg or diastolic blood pressure =100 mmHg) ? Diabetes (use of hypoglycemic drug or fasting blood glucose= 180mg/dl) ? Liver dysfunction (Alanine transaminase or Aspartate Aminotransferase > 80 IU/L) ? Renal dysfunction (creatinine > 1.2 mg/dL) ? Hyperthyroidism or hypothyroidism ? Malignant tumor, heart disease, Cushing's disease, tuberculosis 9) Subjects with hypersensitivity to the test food/placebo or their component or experience of severe food allergy 10) Participation in other human study within one month before the first visit 11) Pregnant or lactating women 12) Subject with difficulty of using smart phone 13) Any condition that the principal investigator believes may put the subjects at undue risk

Design outcomes

Secondary

MeasureTime frame
Level of blood lipid(triglyceride, total cholesterol, HDL-cholesterol, and LDL-cholesterol), and insulin resistence markers(fasting blood glocose, insulin, and HOMA-IR );markers related with lipid metabolism (leptin, and adiponectin), and inflammatory markers (CRP, TNF-a, IL-6);Gene expression related with body fat, metabolism of blood glucose and inflammatory response.

Primary

MeasureTime frame
Area of abdominal fat, body composition ;Anthropometry (body weight, BMI, WC, and waist to hip ratio)

Countries

Korea, Republic of

Contacts

Public ContactJeong-Hyeon Kim

Hallym University Medical Center- Chuncheon

next1203@hanmail.net+82-31-240-5311

Outcome results

None listed

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