NCT02221973

Brief Summary

The aim of LipiDown (Hawthorn + Phytosterol) clinical trial is to test the blood lipids reduction effect of plant sterols and hawthorn in milk powder in a pilot human trial: demonstrate potential to reduce total blood cholesterol more than 10% and/or total triglycerides more than 15%, as required by State food and drug administration (SFDA) regulation.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2013

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2013

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

August 19, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 21, 2014

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2014

Completed
Last Updated

November 13, 2015

Status Verified

August 1, 2014

Enrollment Period

1.3 years

First QC Date

August 19, 2014

Last Update Submit

November 11, 2015

Conditions

Primary Dyslipidemia

Outcome Measures

Primary Outcomes (1)

  • serum concentration of Total Cholesterol (TC),

    after 7 weeks of treatment.

Secondary Outcomes (5)

  • other lipid and lipoprotein parameters in serum samples that could reveal cardiovascular disease (CVD) risk etc.

    at 4 and 7 weeks of treatment

  • biomarkers of lipid oxidation and inflammation

    after 7 weeks of treatment

  • phytosterol metabolism parameters

    after 7 weeks of treatment

  • predictive marker for cardiovascular disease

    after 7 weeks of treatment

  • safety parameters

    after 7 weeks of treatment

Study Arms (3)

milk with 1.2g/d sterols and 8g/d hawthorn powder

EXPERIMENTAL
Dietary Supplement: sterols and hawthorn powder

milk with 1.8g/d sterols and 8g/d hawthorn powder

EXPERIMENTAL
Dietary Supplement: sterols and hawthorn powder

milk without sterols and hawthorn powder

ACTIVE COMPARATOR
Dietary Supplement: sterols and hawthorn powder

Interventions

sterols and hawthorn powderDIETARY_SUPPLEMENT

there are two dose level of sterols (1.2g/d; 1/8g/d)

milk with 1.2g/d sterols and 8g/d hawthorn powdermilk with 1.8g/d sterols and 8g/d hawthorn powdermilk without sterols and hawthorn powder

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Chinese male or female 18 to 65 years old (inclusive). Fasting Serum TC: 5.18-6.21mmol/L (equals to 200-241 mg/dl) AND Serum TG: 1.7-5.65mmol/L (equals to 150- 500 mg/dl) for at least 1 time tested by central laboratory in the past 2 weeks prior to recruitment.
  • Primary dyslipidemia.
  • The subject demonstrates an understanding of the given information and ability to record the requested data.
  • Having obtained his/her informed consent

You may not qualify if:

  • BMI above 32 kg/m2 ( morbid obesity).
  • Pregnant or lactating women or intent to get pregnant.
  • Menopause women on hormonal replacement therapy.
  • Familial hyperlipidemia.
  • Identified food allergy to dairy product or lactose intolerance.
  • Severe diseases in heart, liver, kidney or hematopoietic system before admission.
  • History of angina, myocardial infarction, coronary artery bypass, heart failure or other cardiovascular instability during the last 6 months.
  • History of diabetes, GI, renal, pulmonary, hepatic and biliary, hypothyroidism, mental disease no self-control capacity or no articulate.
  • Subject who are currently taking drugs that interfere with lipid profiles, including but not limited to statin, nicotinic acid, bile acid sequestrant, fibric acids, policosanol tablets.
  • Subject who has received any anti-hyperlipidemia medication in the past 4 weeks.
  • Subject who regularly takes supplements with the function of lipid reduction in the past 3 months or will take during the study (e.g. plant sterols, omega-3 fish oil, beta-glucan, nut-rich diet, soy protein, soluble oat fiber, red yeast rice or other cholesterol reducing functional ingredients).
  • In-patient hyperlipidemia subjects.
  • Alcohol \> 3 glasses wine, or 2 beers, or 1 shot hard alcohol/day.
  • Subject who cannot be expected to comply with the study procedures.
  • Subject who is currently participating or having participated in another clinical trial during the last 4 weeks prior to the beginning of this study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Anzhen Hospital, Capital University of Medical Sciences

Beijing, China

Location

Chao Yang 2nd Hospital

Beijing, China

Location

Chui Yang Liu Hospital

Beijing, China

Location

MeSH Terms

Interventions

Sterols

Intervention Hierarchy (Ancestors)

CholestanesSteroidsFused-Ring CompoundsPolycyclic CompoundsMembrane LipidsLipids

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 19, 2014

First Posted

August 21, 2014

Study Start

July 1, 2013

Primary Completion

October 1, 2014

Study Completion

October 1, 2014

Last Updated

November 13, 2015

Record last verified: 2014-08

Locations

CN(3)