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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

41 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Study Completion Date

2012-01-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Hypercholesterolemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Combinatorial treatment

Group Type EXPERIMENTAL

Psyllium husks

Intervention Type DRUG

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

Isolated soy protein

Intervention Type DIETARY_SUPPLEMENT

Oral suspension, oral use, 30 grams once per day

Single treatment: Psyllium husks

Group Type ACTIVE_COMPARATOR

Psyllium husks

Intervention Type DRUG

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

Isolated whey protein

Intervention Type DIETARY_SUPPLEMENT

Oral suspension, oral use, 30 grams once per day

Single treatment: Isolated soy protein

Group Type ACTIVE_COMPARATOR

Isolated soy protein

Intervention Type DIETARY_SUPPLEMENT

Oral suspension, oral use, 30 grams once per day

Microcrystalline cellulose

Intervention Type OTHER

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

Control

Group Type PLACEBO_COMPARATOR

Isolated whey protein

Intervention Type DIETARY_SUPPLEMENT

Oral suspension, oral use, 30 grams once per day

Microcrystalline cellulose

Intervention Type OTHER

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

Interventions

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Psyllium husks

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

Intervention Type DRUG

Isolated soy protein

Oral suspension, oral use, 30 grams once per day

Intervention Type DIETARY_SUPPLEMENT

Isolated whey protein

Oral suspension, oral use, 30 grams once per day

Intervention Type DIETARY_SUPPLEMENT

Microcrystalline cellulose

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

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* 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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes