Cholesterol Lowering Treatment With Psyllium Husks and Isolated Soy Protein in Hypercholesterolemia

NCT01251991 | Completed Phase 4

• 1 other identifier: 2010-022822-34
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

Brief Summary

Despite improved treatment, cardiovascular disease remains one of the most common diseases and causes of death in the Western world. Hypercholesterolemia is a well known risk factor for developing cardiovascular disease. Prevention and treatment are based in part on lowering LDL cholesterol. Dietary and lifestyle changes always play an important part of the treatment and preventive effort, and conversion to a heart-healthy diet reduces LDL cholesterol by a mean 10%. Further lowering of LDL cholesterol by means of food supplements have been demonstrated in numerous studies. Cholesterol lowering food supplements include isolated soy protein and water soluble dietary fibre such as psyllium husks. Postulated mechanisms of action responsible for the cholesterol lowering in these two food supplements are different, so there is a reason to expect an additive cholesterol lowering effect during concomitant treatment with both substances. The investigators want to investigate whether concomitant treatment with psyllium husks and isolated soy protein in addition to a heart-healthy diet results in a significantly greater reduction of LDL cholesterol in hypercholesterolemia, than single treatment with each of the substances.

Conditions

Hypercholesterolemia

Outcome Measures

Primary Outcomes (1)

• Change from baseline in LDL cholesterol at 6 weeks

  3rd and 4th visits equal the ends of the 1st and 2nd intervention period at +6 weeks and +16 weeks from baseline respectively (4 week wash-out period in between the intervention periods). 2nd visit includes randomization and baseline measurement, while 1st visit @ -4 weeks compared to baseline includes screening and inclusion

  3rd and 4th visits at the investigational site

Secondary Outcomes (8)

• Change from baseline in total cholesterol at 6 weeks

  3rd and 4th visits at the investigational site

• Change from baseline in HDL cholesterol at 6 weeks

  3rd and 4th visits at the investigational site

• Change from baseline in triglycerides at 6 weeks

  3rd and 4th visits at the investigational site

• Change from baseline in fasting plasma glucose at 6 weeks

  3rd and 4th visits at the investigational site

• Change from baseline in body weight at 6 weeks

  3rd and 4th visits at the investigational site

Study Arms (4)

Combinatorial treatment

EXPERIMENTAL

Drug: Psyllium husks; Dietary Supplement: Isolated soy protein

Single treatment: Psyllium husks

ACTIVE COMPARATOR

Drug: Psyllium husks; Dietary Supplement: Isolated whey protein

Single treatment: Isolated soy protein

ACTIVE COMPARATOR

Dietary Supplement: Isolated soy protein; Other: Microcrystalline cellulose

Control

PLACEBO COMPARATOR

Dietary Supplement: Isolated whey protein; Other: Microcrystalline cellulose

Interventions

Psyllium husks DRUG

Oral suspension, oral use, two daily dosages consisting of 5 grams each

Combinatorial treatment; Single treatment: Psyllium husks

Isolated soy protein DIETARY_SUPPLEMENT

Oral suspension, oral use, 30 grams once per day

Combinatorial treatment; Single treatment: Isolated soy protein

Isolated whey protein DIETARY_SUPPLEMENT

Oral suspension, oral use, 30 grams once per day

Control; Single treatment: Psyllium husks

Microcrystalline cellulose OTHER

Oral suspension, oral use, two daily dosages consisting of 5 grams each

Control; Single treatment: Isolated soy protein

Eligibility Criteria

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

You may qualify if:

• BMI 18,5 - 35 kg/m2
• LDL cholesterol \> 3,5 mmol/l

You may not qualify if:

• Triglycerides \> 5,0 mmol/l
• Use of phytosterols, food supplements containing soy protein or water soluble fiber supplements
• Cardiovascular disease
• Diabetes mellitus
• Gastrointestinal disease
• Liver- og kidney disease
• Electrolyte imbalance
• Orlistat treatment
• Alcohol abuse
• Hypersensitivity to the interventional substances
• Pregnancy and nursing

Sponsors & Collaborators

• Aalborg University Hospital: lead

Study Sites (1)

The Lipid Clinic, Aalborg Hospital

Aalborg, RN, 9000, Denmark

Location

MeSH Terms

Conditions

Hypercholesterolemia

Interventions

Soybean Proteins; microcrystalline cellulose

Condition Hierarchy (Ancestors)

Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Plant Proteins; Proteins; Amino Acids, Peptides, and Proteins; Plant Proteins, Dietary; Dietary Proteins; Food; Diet, Food, and Nutrition; Physiological Phenomena; Soy Foods; Vegetable Products; Vegetables; Food and Beverages

Study Officials

• Erik B. Schmidt, Professor, MD

  Lipidklinikken, Aalborg Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical dietitian

Study Record Dates

• First Submitted: December 1, 2010
• First Posted: December 2, 2010
• Study Start: January 1, 2011
• Primary Completion: January 1, 2012
• Study Completion: January 1, 2012
• Last Updated: January 29, 2014

Record last verified: 2011-06

Locations

DK (1)