Heterozygous Familial HypercholesterolemiaSOYFITNCT03563547
Effects of Soy Protein on Cholesterol Levels in Children Affected With Familial Hypercholesterolemia
A study testing Dietary counseling (fat modifed diet) and Dietary Counseling (fat modified + soy enriched diet) in people with Heterozygous Familial Hypercholesterolemia, run by Austrian Academic Institute for Clinical Nutrition at 1 site in Austria.
Trial summary
Familial hypercholesterolemia (FH) is an inheritable, autosomal dominant disorder leading to pathologically increased levels of low-density-lipoprotein cholesterol (LDL-C). Dietary treatment remains an important tool in the management of affected children even after the decision for the initiation of pharmacotherapy… Read more about this study
- Who is it for?
- Ages 4 to 14 years
- Conditions the study is for
- Heterozygous Familial Hypercholesterolemia
- What is being tested?
- Dietary counseling (fat modifed diet) and Dietary Counseling (fat modified + soy enriched diet)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteAustria
- Study dates
- 3 Sep 2009to 9 Oct 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Informed consent of both the patient and their legal guardian, age of 4 to 14, diagnosis of definite FH using the Simon Broome criteria, body weight within normal age-specific percentile range (Kromeyer-Hauschild et al.), the proven ability and willingness to adhere to a fat-modified diet.
Who cannot join
- Metabolic or genetic disorders other than FH, current infectious disease, current or history of cancerous disease, current treatment with lipid lowering drugs, failure to complete all trial-related assessments, reported habit of consuming soy products or adherence to a non-standard diet (e.g. vegetarianism) prior to enrolment into the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of a Fat Modified Diet Enriched With Soy Protein on Cholesterol Levels in Children Affected With Heterozygous Familial Hypercholesterolemia: a Randomized Controlled Study
Familial hypercholesterolemia (FH) is an inheritable, autosomal dominant disorder leading to pathologically increased levels of low-density-lipoprotein cholesterol (LDL-C). Dietary treatment remains an important tool in the management of affected children even after the decision for the initiation of pharmacotherapy is made. However, little evidence is available on the beneficial effects of diets low in saturated fat and cholesterol and diets enriched with soy in children affected with FH. Based on these previous findings we hypothesize that the LDL-C lowering effect of a fat-modified diet could be further increased by the addition of soy-protein in children affected with HeFH.
Read the detailed description
This study is a prospective randomized controlled trial. The enrolled subjects were recruited from the outpatient clinic for disorders of metabolism of the Medical University of Vienna. Subjects were either allocated into a group treated with a dietary regimen high in unsaturated fats, low in saturated fats and enriched with soy-protein ("soy group") or a group treated with a diet high in unsaturated fats and low in saturated fats ("control group") alone at random. All subjects had been instructed to adhere to a fat-modified diet as described below prior to enrolment into the study as part of their routine treatment. Prior to being considered for inclusion in the study all subjects had to undergo nutritional protocoling using 24h dietary recall protocols, which were completed by their legal guardians, for 7 days. This was done to confirm adherence to the routine dietary treatment. Furthermore, all patients had been screened for metabolic diseases other than FH as part of their initial routine assessment in our specialised centre.
Subjects in both groups had been instructed to achieve specific daily maximum intakes in total fat (≤ 30% of total energy intake), saturated fatty acids (≤10% of total fat intake) and cholesterol (≤ 300 mg). Furthermore the participating families had been trained to replace as many visible fat sources as possible with rapeseed oil due to its favorable composition of polyunsaturated fatty acids.24 Subjects allocated to the soy group and their families were additionally instructed to consume at least 0.25 g of soy protein per kg bodyweight per day and were provided with recipes and practical advice on how to achieve this goal. Example provided: a child with a bodyweight of 30kg would have to consume the equivalent of approx. 50g of Tofu per day to meet the treatment target. This dosage had been reported as effective for LDL-C reduction in children in a previous, non-controlled study.10
Further appointments with an experienced dietitian were made after enrolment for both treatment groups, totalling 7 training sessions (60 minutes each) over the course of the first 7 weeks of the trial. This was done to identify possible issues with the practical implementation of especially the soy-enriched diet.
Patients were asked to provide weekly urine samples and blood was drawn immediately after enrolment, week 7 and week 13, respectively. The urine- and plasma samples were immediately frozen and later analysed for their isoflavone content. Isoflavone levels were assessed at baseline to verify that the respective patients did not consume soy products prior to the trial. All enrolled subjects had to participate for 13 weeks or were excluded from the statistical evaluation (per protocol analysis). If relevant levels of isoflavones were detected in either urine or plasma of subjects in the Control-group the subjects were to be excluded from any further statistical evaluation.
The study was approved by the Ethics Committee of the Medical University of Vienna. Informed consent from all participating subjects and their legal guardians was obtained prior to their enrolment in the study. Our research was conducted in accordance with the latest Declaration of Helsinki.
- Being tested
- Dietary counseling (fat modifed diet), Dietary Counseling (fat modified + soy enriched diet)
- Keywords
- LDL-Cholesterol, Heterozygous Familial Hypercholesterolemia, Paediatrics, Dietary Treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary counseling (fat modifed diet)Behavioural
Subjects in both groups had been instructed to achieve specific daily maximum intakes in total fat (≤ 30% of total energy intake), saturated fatty acids (≤10% of total fat intake) and cholesterol (≤ 300 mg). Furthermore the participating families had been trained to replace as many visible fat sources as possible with rapeseed oil due to its favorable composition of polyunsaturated fatty acids.
Dietary Counseling (fat modified + soy enriched diet)Behavioural
Subjects in both groups had been instructed to achieve specific daily maximum intakes in total fat (≤ 30% of total energy intake), saturated fatty acids (≤10% of total fat intake) and cholesterol (≤ 300 mg). Furthermore the participating families had been trained to replace as many visible fat sources as possible with rapeseed oil due to its favorable composition of polyunsaturated fatty acids.
Subjects allocated to the soy group and their families were additionally instructed to consume at least 0.25 g of soy protein per kg bodyweight per day and were provided with recipes and practical advice on how to achieve this goal. Example provided: a child with a bodyweight of 30kg would have to consume the equivalent of approx. 50g of Tofu per day to meet the treatment target.
| Study group | Role | What they receive |
|---|---|---|
| Fat modified diet | Active comparator | Subjects in this arm had been instructed to achieve specific daily maximum intakes in total fat (≤ 30% of total energy intake), saturated fatty acids (≤10% of total fat intake) and cholesterol (≤ 300 mg). Furthermore the participating families had been trained to replace as many visible fat sources as possible with rapeseed oil due to its favorable composition of polyunsaturated fatty acids. Receives: Behavioral: Dietary counseling (fat modifed diet) |
| Fat modifed diet enriched with soy protein | Experimental | Subjects in this arm had been instructed to achieve specific daily maximum intakes in total fat (≤ 30% of total energy intake), saturated fatty acids (≤10% of total fat intake) and cholesterol (≤ 300 mg). Furthermore the participating families had been trained to replace as many visible fat sources as possible with rapeseed oil due to its favorable composition of polyunsaturated fatty acids.
Subjects in this arm were additionally instructed to consume at least 0.25 g of soy protein per kg bodyweight per day and were provided with recipes and practical advice on how to achieve this goal. Example provided: a child with a bodyweight of 30kg would have to consume the equivalent of approx. 50g of Tofu per day to meet the treatment target. Receives: Behavioral: Dietary Counseling (fat modified + soy enriched diet) |
What is being measured
The primary outcome is the main question the study is designed to answer.
LDL-C change from baseline
Measured: 13 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2018
- Study start3 Sep 2009
- Primary completion9 Oct 2014
- Study completion9 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Heterozygous Familial HypercholesterolemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Austrian Academic Institute for Clinical Nutrition
- Sponsor type
- University, hospital or other
- Collaborators
- Medical University of Vienna
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03563547
- Sponsor's protocol ID
- SoyfitKW01
- Acronym
- SOYFIT
- Status last verified
- Jun 2018
- First submitted
- 11 Jun 2018
- Last updated
- 20 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Helk O, Widhalm K. Effects of a low-fat dietary regimen enriched with soy in children affected with heterozygous familial hypercholesterolemia. Clin Nutr ESPEN. 2020 Apr;36:150-156. doi: 10.1016/j.clnesp.2019.09.009. Epub 2020 Jan 31.
PubMed 32220359
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Fat Modified Diet Enriched With Soy Protein on Cholesterol Levels in Children Affected With Heterozygous Familial Hypercholesterolemia: a Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT03563547
- Acronym / sponsor ID
- SOYFIT / SoyfitKW01
- Keywords
- LDL-Cholesterol, Heterozygous Familial Hypercholesterolemia, Paediatrics, Dietary Treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Austrian Academic Institute for Clinical NutritionUniversity, hospital or other
- Collaborators
- Medical University of Vienna
- Study start
- 3 Sep 2009 (actual)
- Primary completion
- 9 Oct 2014 (actual)
- Study completion
- 9 Oct 2017 (actual)
- First posted
- 20 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Familial hypercholesterolemia (FH) is an inheritable, autosomal dominant disorder leading to pathologically increased levels of low-density-lipoprotein cholesterol (LDL-C). Dietary treatment remains an important tool in the management of affected children even after the decision for the initiation of pharmacotherapy is made. However, little evidence is available on the beneficial effects of diets low in saturated fat and cholesterol and diets enriched with soy in children affected with FH. Based on these previous findings we hypothesize that the LDL-C lowering effect of a fat-modified diet could be further increased by the addition of soy-protein in children affected with HeFH.
Detailed description
This study is a prospective randomized controlled trial. The enrolled subjects were recruited from the outpatient clinic for disorders of metabolism of the Medical University of Vienna. Subjects were either allocated into a group treated with a dietary regimen high in unsaturated fats, low in saturated fats and enriched with soy-protein ("soy group") or a group treated with a diet high in unsaturated fats and low in saturated fats ("control group") alone at random. All subjects had been instructed to adhere to a fat-modified diet as described below prior to enrolment into the study as part of their routine treatment. Prior to being considered for inclusion in the study all subjects had to undergo nutritional protocoling using 24h dietary recall protocols, which were completed by their legal guardians, for 7 days. This was done to confirm adherence to the routine dietary treatment. Furthermore, all patients had been screened for metabolic diseases other than FH as part of their initial routine assessment in our specialised centre.
Subjects in both groups had been instructed to achieve specific daily maximum intakes in total fat (≤ 30% of total energy intake), saturated fatty acids (≤10% of total fat intake) and cholesterol (≤ 300 mg). Furthermore the participating families had been trained to replace as many visible fat sources as possible with rapeseed oil due to its favorable composition of polyunsaturated fatty acids.24 Subjects allocated to the soy group and their families were additionally instructed to consume at least 0.25 g of soy protein per kg bodyweight per day and were provided with recipes and practical advice on how to achieve this goal. Example provided: a child with a bodyweight of 30kg would have to consume the equivalent of approx. 50g of Tofu per day to meet the treatment target. This dosage had been reported as effective for LDL-C reduction in children in a previous, non-controlled study.10
Further appointments with an experienced dietitian were made after enrolment for both treatment groups, totalling 7 training sessions (60 minutes each) over the course of the first 7 weeks of the trial. This was done to identify possible issues with the practical implementation of especially the soy-enriched diet.
Patients were asked to provide weekly urine samples and blood was drawn immediately after enrolment, week 7 and week 13, respectively. The urine- and plasma samples were immediately frozen and later analysed for their isoflavone content. Isoflavone levels were assessed at baseline to verify that the respective patients did not consume soy products prior to the trial. All enrolled subjects had to participate for 13 weeks or were excluded from the statistical evaluation (per protocol analysis). If relevant levels of isoflavones were detected in either urine or plasma of subjects in the Control-group the subjects were to be excluded from any further statistical evaluation.
The study was approved by the Ethics Committee of the Medical University of Vienna. Informed consent from all participating subjects and their legal guardians was obtained prior to their enrolment in the study. Our research was conducted in accordance with the latest Declaration of Helsinki.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fat modified diet | Active comparator | Behavioral: Dietary counseling (fat modifed diet)Subjects in this arm had been instructed to achieve specific daily maximum intakes in total fat (≤ 30% of total energy intake), saturated fatty acids (≤10% of total fat intake) and cholesterol (≤ 300 mg). Furthermore the participating families had been trained to replace as many visible fat sources as possible with rapeseed oil due to its favorable composition of polyunsaturated fatty acids. |
| Fat modifed diet enriched with soy protein | Experimental | Behavioral: Dietary Counseling (fat modified + soy enriched diet)Subjects in this arm had been instructed to achieve specific daily maximum intakes in total fat (≤ 30% of total energy intake), saturated fatty acids (≤10% of total fat intake) and cholesterol (≤ 300 mg). Furthermore the participating families had been trained to replace as many visible fat sources as possible with rapeseed oil due to its favorable composition of polyunsaturated fatty acids. Subjects in this arm were additionally instructed to consume at least 0.25 g of soy protein per kg bodyweight per day and were provided with recipes and practical advice on how to achieve this goal. Example provided: a child with a bodyweight of 30kg would have to consume the equivalent of approx. 50g of Tofu per day to meet the treatment target. |
Who may qualify
- Ages
- 4 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Informed consent of both the patient and their legal guardian, age of 4 to 14, diagnosis of definite FH using the Simon Broome criteria, body weight within normal age-specific percentile range (Kromeyer-Hauschild et al.), the proven ability and willingness to adhere to a fat-modified diet.
Key exclusion criteria (1 listed)
- Metabolic or genetic disorders other than FH, current infectious disease, current or history of cancerous disease, current treatment with lipid lowering drugs, failure to complete all trial-related assessments, reported habit of consuming soy products or adherence to a non-standard diet (e.g. vegetarianism) prior to enrolment into the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dietary counseling (fat modifed diet)Subjects in both groups had been instructed to achieve specific daily maximum intakes in total fat (≤ 30% of total energy intake), saturated fatty acids (≤10% of total fat intake) and cholesterol (≤ 300 mg). Furthermore the participating families had been trained to replace as many visible fat sources as possible with rapeseed oil due to its favorable composition of polyunsaturated fatty acids. | Behavioural | Fat modified diet |
| Dietary Counseling (fat modified + soy enriched diet)Subjects in both groups had been instructed to achieve specific daily maximum intakes in total fat (≤ 30% of total energy intake), saturated fatty acids (≤10% of total fat intake) and cholesterol (≤ 300 mg). Furthermore the participating families had been trained to replace as many visible fat sources as possible with rapeseed oil due to its favorable composition of polyunsaturated fatty acids. Subjects allocated to the soy group and their families were additionally instructed to consume at least 0.25 g of soy protein per kg bodyweight per day and were provided with recipes and practical advice on how to achieve this goal. Example provided: a child with a bodyweight of 30kg would have to consume the equivalent of approx. 50g of Tofu per day to meet the treatment target. | Behavioural | Fat modifed diet enriched with soy protein |
Primary outcome
LDL-C change from baseline
Time frame: 13 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2018.
- Derived from this study: PubMed 32220359Helk O, Widhalm K. Effects of a low-fat dietary regimen enriched with soy in children affected with heterozygous familial hypercholesterolemia. Clin Nutr ESPEN. 2020 Apr;36:150-156. doi: 10.1016/j.clnesp.2019.09.009. Epub 2020 Jan 31.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dietary counseling (fat modifed diet) and Dietary Counseling (fat modified + soy enriched diet) in people with Heterozygous Familial Hypercholesterolemia, run by Austrian Academic Institute for Clinical Nutrition at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
LDL-C change from baseline (time frame: 13 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03563547, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jun 2018.