Effect of NUTRIOSE®FB 06 (dietary ingredient) on lipid profile and other associated parameters

Phase 4

• Conditions: Health Condition 1: null- Hypercholesterolemia

• Registration Number: CTRI/2012/11/003134
• Lead Sponsor: Roquette Lestrem

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 90

Inclusion Criteria

1.Female subjects aged 30-65 of years of age

2.Female subjects of childbearing potential must have negative pregnancy test at screening and must use an appropriate method of contraception

3.LDL-cholesterol level 1.3g/L to 1.89g/L

4.Non-diabetic subjects

5.BMI: 25-30 kg/m2

6.Willingness to sign informed consent

Exclusion Criteria

1.History of metabolic disorders (at least 3 of the following is required):

a.Waist circumference greator than 35 inches

b.Plasma triglycerides greator than 150 mg/dL

c.HDL-C less than 50 mg/dL

d.Blood pressure greator than or equal to 130/85 mm Hg

e.Fasting plasma glucose 110-125 mg/dL

2.Severe disease able to influence the results (e.g. nephritic syndrome or cholestasis or any other condition which in PIâ??s discretion would otherwise alter trial results)

3.Subjects with high serum triglycerides (defined by more than 250 mg/dL)

4.Subjects with high blood pressure (defined by more than 160/100 mm Hg)

5.History of severe cardiac disease within the past 6 months

6.History of gastrointestinal disease (chronic inflammatory disease, irritable bowel syndrome, inflammatory bowel disease, current diarrhoea, constipation and liver diseases like hepatitis)

7.Use of laxatives during previous 2 weeks

8.Pregnant and lactating females

9.Subjects on oral contraceptives/hormonal/IUCD

10.Subjects consuming corticosteroids

11.People receiving lipid-lowering drugs (including statins, fibrates, etc.)

12.Subjects undergoing excessive physical activity (more than 7 hours per week)

13.Subjects known to be allergic to any ingredient present in the study product

14.Participation in any other investigational study within the entire study period including the follow-up period

15.Consumption of dietary supplements or food containing ingredients with cholesterol lowering effects (e.g.: phytosterols, omega 3, soya beans, etc.)

16.Subjects using any alternative treatment like ayurvedic medicine, homeopathic medicine for cholesterol reduction

Study & Design

• Study Type: PMS
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary endpoint is to determine the effect of NUTRIOSE®FB 06 in decreasing LDL C till Week 12.Timepoint: Week 12.

Secondary Outcome Measures

Name	Time	Method
The secondary end points of the study are to determine the effects of NUTRIOSE®FB 06 in the levels of: <br/ ><br>�Total cholesterol <br/ ><br>�HDL-Cholesterol <br/ ><br>�VLDL-Cholesterol <br/ ><br>�Triglycerides <br/ ><br>�Adiponectin <br/ ><br>�Apolipoprotein A1 and apolipoprotein B <br/ ><br>�Blood Glucose (Fasting and Post Prandial) <br/ ><br>�HbA1C <br/ ><br>�Blood Insulin levels <br/ ><br>�CRP <br/ ><br>�Blood pressure <br/ ><br>�BMI <br/ ><br>�Weight <br/ ><br>�Waist circumference <br/ ><br>�Adverse events, if any <br/ ><br>Timepoint: Time point for all endpoints: Week 12