Lipid Lowering Effect of a Cereal Based Snack Bar With Added Plant Stanol Ester

NCT03284918 | Completed

• 1 other identifier: MFRA004
• Study Type: interventional
• Target: 71
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of the study is to investigate the cholesterol lowering efficacy of a cereal based snack bar with added plant stanol ester when used between meals as part of a habitual diet by subjects with mild to moderate hypercholesterolemia.

Conditions

Hypercholesterolemia; Hyperlipidemias; Dyslipidemias

Outcome Measures

Primary Outcomes (1)

• Percentage change in serum LDL cholesterol

  4 weeks

Secondary Outcomes (2)

• Absolute change in serum LDL cholesterol (mmol/l)

  4 weeks

• Absolute and percentage change in serum total, HDL- and non-HDL cholesterol and serum total triglycerides

  4 weeks

Study Arms (2)

Plant stanol ester

EXPERIMENTAL

Cereal based snack bar with added plant stanol ester (0.8 g plant stanols/bar). Two bars consumed daily as a snack, between meals, for 4 weeks (1.6 g plant stanols/d).

Dietary Supplement: Plant stanol ester

Placebo

PLACEBO COMPARATOR

Cereal based snack bar without plant stanol ester. Two bars consumed daily as a snack, between meals, for 4 weeks (0 g plant stanols/d).

Dietary Supplement: Placebo

Interventions

Plant stanol ester DIETARY_SUPPLEMENT

Plant stanol ester

Placebo DIETARY_SUPPLEMENT

Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Serum total cholesterol 5.2-8.5 mmol/l
• Serum triglycerides \< 3 mmol/l
• Signed written informed consent

You may not qualify if:

• Abnormal liver, kidney and thyroid function
• Use of lipid lowering medication
• Consumption of other plant sterol or plant stanol containing food products or supplements, or other foods or supplements for cholesterol lowering 1 month prior to visit 2
• History of unstable coronary artery disease (myocardial infarction, coronary artery bypass graft (CABG), percutaneous transluminal coronary angioplasty (PTCA) within the previous 6 months
• Diagnosed type 1 or type 2 diabetes requiring medical treatment
• History of recent temporal ischemic attack or malignant diseases (\< 5 yrs)
• Celiac disease, or allergy or intolerance to the ingredients of the test products
• Medically prescribed diet/medication for slimming or a special diet like very low calorie diet or obesity drug, or vegan and gluten-free diet
• Subjects with alcohol abuse (\> 4 portion per day)
• Pregnancy or planned pregnancy or lactating

Sponsors & Collaborators

• Raisio Group: lead
• Oy Medfiles Ltd: collaborator

Related Publications (1)

• Sarkkinen E, Lyyra M, Nieminen S, Kuusisto P, Wester I. Cereal-Based Snack Bar with Added Plant Stanol Ester (Benecol(R)) Consumed between Meals Lowers Serum Total and LDL Cholesterol Effectively in Mildly to Moderately Hypercholesterolemic Subjects. Cholesterol. 2018 May 2;2018:1463628. doi: 10.1155/2018/1463628. eCollection 2018.

  PMID: 29854447 DERIVED

MeSH Terms

Conditions

Hypercholesterolemia; Hyperlipidemias; Dyslipidemias

Interventions

plant stanol ester

Condition Hierarchy (Ancestors)

Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

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

Study Record Dates

• First Submitted: September 13, 2017
• First Posted: September 15, 2017
• Study Start: January 1, 2016
• Primary Completion: March 1, 2016
• Study Completion: September 1, 2016
• Last Updated: September 15, 2017

Record last verified: 2017-09