A Clinical Study for Evaluating the Safety of a Plant Sterol-enriched Fermented Dairy Product in Japanese Healthy Adults

NCT02278393 | Completed

• 1 other identifier: NU360
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

Brief Summary

Investigate the safety of excessive consumption of plant sterol-enriched fermented dairy product over a 4-week period in Japanese healthy adults

Conditions

Healthy Volunteers

Keywords

Japanese healthy volunteers; High LDL-C; dairy drinks; phytosterols

Outcome Measures

Primary Outcomes (1)

• Adverse Events

  Number of subjects with at least one adverse event by study group

  From baseline to 6 weeks (4-week consumption + 2-week follow-up periods)

Secondary Outcomes (5)

• Adverse Events

  From baseline to 6 weeks (4-week consumption + 2-week follow-up periods)

• Vital signs

  From baseline to 6 weeks (4-week consumption + 2-week follow-up periods)

• Vital signs

  From baseline to 6 weeks (4-week consumption + 2-week follow-up periods)

• Laboratory measurements

  From baseline to 6 weeks (4-week consumption + 2-week follow-up periods)

• Laboratory measurements

  From baseline to 6 weeks (4-week consumption + 2-week follow-up periods)

Study Arms (2)

1-Fermented Dairy Product with Phytosterols (test)

ACTIVE COMPARATOR

one arm active = 3 bottles of test product/day with 1,6g of phytosterols each

Other: 1-Fermented Dairy Product with Phytosterols (test)

2-Fermented dairy Product with No Phytosterols (control)

PLACEBO COMPARATOR

one arm control product= 3 bottles test productl/day with no Phytosterols

Other: 2-Fermented dairy Product with No Phytosterols (control)

Interventions

1-Fermented Dairy Product with Phytosterols (test) OTHER

1- 3 bottles of test product/day

1-Fermented Dairy Product with Phytosterols (test)

2-Fermented dairy Product with No Phytosterols (control) OTHER

2-3 bottles of control product/day

2-Fermented dairy Product with No Phytosterols (control)

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• II 01: Male/female subject, aged from 20 to 55 years (bounds included).
• II 02: Subject with body mass index (BMI) between 18.5 kg/m2 (bound included) and 30 kg/m2 (bound excluded).
• II 03: Subject with LDL-cholesterol plasma level under 140 mg/dL (3.6 mmol/L) (bound excluded).
• II 04: Subject with triglycerides under 200 mg/dL (2.3 mmol/L) (bound included).
• II 05: Non hypertensive subject defined with Systolic Blood Pressure (SBP) \<140mmHg and Diastolic Blood Pressure (DBP) \<90 mmHg.
• II 06: Subject agreeing not to consume any supplements/excessive plant sterols and plant stanols in any form during the study period.
• II 07: If of childbearing potential, female subject must be using or complying with one of the following medically approved methods of contraception such as, but not exclusively:
• Oral birth control pills (at least 1 full monthly cycle prior to study product administration);
• Intra-uterine device (IUD);
• Double barrier methods (such as condoms and spermicide); OR female subject must be postmenopausal for at least 12 months prior to trial entry or surgically sterile (i.e. hysterectomy, bilateral oophorectomy or bilateral tubal ligation).
• II 08: Subject covered by social security or covered by similar system.
• II 09: Subject, upon briefing of the content of the present study, fully understanding and agreeing to its objective; and being able to personally sign a written informed consent.
• II 10: Subject having given written (dated and signed) inform consent to take part in the study.
• II 11: Asian subjects originating from Japan
• II12: Subject who is able to communicate well with the investigator and to comply with the requirements of the entire study.

You may not qualify if:

• IE 01: Subject having experienced any cardiovascular event (cardiac infarction, angina attack, surgical or endoscopic coronary angioplasty, stroke, arterial disease, etc.).
• IE 02: Subject suffering from any serious or chronic liver, renal, cardiovascular, respiratory, endocrine or metabolic disorders.
• IE 03: Subject with gastro-intestinal disorders (such as diarrhoea, constipation, irritable bowel syndrome) or using laxatives.
• IE 04: Subject with diabetes Type I and Type II or Fasting Blood Sugar test (FBS) \> 125 mg/dL at screening visit.
• IE 05: Subject with active liver disease or hepatic dysfunction as defined by elevations in liver enzymes: \[alanine aminotransferase (ALT), aspartate aminotransferase (AST), gamma glutamyl transferase (GGT) \> 3X the upper limit of normal (ULN).
• IE 08: Subject taking any hypocholesterolemic drugs or products (statins, ezetimibe, sequesterants, niacin, nicotinates, probucol, omega-3 fatty acids (EPA-DHA, ALA…), and fibrates).
• IE 09: Subjects having stopped their hypocholesterolemic drugs or products for less than 3 months
• IE 10: Subject with known lactose intolerance.
• IE 11: Subject with known allergy or hypersensitivity to plant sterols and to any component of the study product (milk protein for example).
• IE 12: Subjects having sitosterolemia.
• IE 13: Subject who had any surgery or intervention requiring a general anaesthesia in the preceding 4 weeks, or who plans to have one during the course of the study.
• IE 14: Subject receiving (currently or in the 4 last weeks) systemic treatment or topical treatment likely to interfere with evaluation of the study parameters.
• IE 16 Subject having blood sample of 200 mL or more taken (e.g., donated blood) within 1 month, or 400 mL or more within 3 months before the start of the present study.
• IE 17: Subject with heavy alcohol intake (\> 60 g/day).
• IE 18: Subject taking any treatment for anorexia, weight loss, or any form of treatment likely to interfere with metabolism or dietary habits (e.g. hypolipemic, hypoglycaemic treatments).

Sponsors & Collaborators

• Danone Japan: lead

Study Sites (1)

Yaesu Sakura-dori Clinic

Tokyo, 103-0028, Japan

Location

MeSH Terms

Interventions

Phytosterols

Intervention Hierarchy (Ancestors)

Sterols; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Membrane Lipids; Lipids; Phytochemicals; Biological Factors

Study Officials

• Christine MRINI, MD, PHD

  Danone Research Life Sciences

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 16, 2014
• First Posted: October 30, 2014
• Study Start: February 1, 2014
• Primary Completion: May 1, 2014
• Study Completion: May 1, 2014
• Last Updated: October 30, 2014

Record last verified: 2014-10

Locations

JP (1)