HypercholesterolemiaNCT04148976
Effect of Dietary Intervention on LDL-C and Lipoprotein Subclasses Distribution in Patients With Hypercholesterolemia
A study testing Dietary portfolio in people with Hypercholesterolemia and Disease, run by Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran.
Trial summary
The primary aim of the present study was to elucidate the effect of a combination of functional foods on the low-density lipoprotein cholesterol (LDL-C) levels and on the distribution of the lipoprotein subclasses in subjects with hypercholesterolemia. Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Hypercholesterolemia, Disease, Dyslipidemias
- What is being tested?
- Dietary portfolio
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 62 participants
- Where
- No sites listed yet
- Study dates
- 28 Feb 2013to 18 Dec 2018
- 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 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Men and women
- Body mass index (BMI) 25 to ≤ 39.9 kg/m2
- Adults between 20 and 60 years of age
- Total cholesterol levels of >200mg/dL in serum
- LDL-C levels ≥130mg/dL ≤190mg/dL
- Literate subjects
- Signature of informed consent
Who cannot join
- Subjects with diabetes
- Diseases that produce obesity or diabetes
- Cardiovascular events
- Weight-loss of ≥ 3kg on the preceding months to the study
- Catabolic diseases such as cancer and acquired immunodeficiency syndrome
- Pregnancy and breastfeeding
Show all 11Show fewer
- Positive Smoking
- Pharmacological treatment including:
- Antihypertensive drugs Hypoglycemic agents Statins, fibrates or any other treatment for dyslipidemia Steroid medications Chemotherapy, immunosuppressants, and radiotherapy Anorexigens or other medication to induce weight-loss
- Subjects with high cardiovascular risk
- Subjects with symptomatic digestive pathologies
About this study
Official title: Effect of Dietary Intervention on LDL-C Levels and Lipoprotein Subclasses Distribution in Patients With Hypercholesterolemia
The primary aim of the present study was to elucidate the effect of a combination of functional foods on the low-density lipoprotein cholesterol (LDL-C) levels and on the distribution of the lipoprotein subclasses in subjects with hypercholesterolemia. To accomplish the latter, subjects that met the inclusion criteria and had mild hypercholesterolemia (Total cholesterol >200mg/dL, and LDL-C >130mg/dL <190 mg/dL) were recruited for double-blind, parallel, controlled dietary intervention study. After two weeks of dietary standardization with an isocaloric diet, subjects were randomized and allocated to either placebo or a dietary portfolio treatment for two months. The secondary endpoints were the size of the different lipoprotein subclasses, total cholesterol levels, high density -lipoprotein cholesterol (HDL-C) levels, apolipoprotein B, triglycerides, total/HDL-C ratio, apolipoprotein B/apolipoprotein A ratio, and anthropometric measurements.
Read the detailed description
The present work took place at the Department of Physiology of Nutrition at the Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran (INCMNSZ). The study followed a randomized, controlled, double-blind, parallel design encompassing five visits. On the first visit, volunteers were screened for eligibility criteria. Subjects that met the inclusion criteria were then invited to a second visit. Herein, volunteers received a thorough explanation of the experimental maneuver, as well as the overall objectives of the study. Thereafter, subjects who agreed to participate signed a consent form.
Upon agreement, assessment of habitual dietary intake and physical activity was obtained by 24-hour dietary recalls, food frequency questionnaire (FFQ), and by the International Physical Activity Questionnaire (IPAQ), respectively. Additionally, anthropometric measurements and blood samples were registered and collected. Then, volunteers underwent dietary standardization for two weeks with isocaloric diets (LSFD), which followed the National Cholesterol Education Program (NCEP) , Adult Treatment Panel III (ATP III) criteria. That is, 50-60% carbohydrates, 15% protein, 25-35% fat,<7% saturated fat,≤ 200mg of dietary cholesterol, 20-35g of fiber, and 2000mg/d of sodium.
On the third visit, subjects were randomly allocated to either LSFD plus placebo or an LSFD plus the dietary portfolio (DP). Of note, the prescribed diets were matched to the volunteers' habitual caloric intake -considering the energy provided by the placebo or DP- to avoid variability of the endpoint variables due to weight-loss. The DP and placebo provided 200kcal; the DP included 25g of soy protein, 14g of dehydrated nopal,14g of oats, 4g of chia seeds, 4g of inulin, and 0.15g of flavoring. The placebo consisted of 30g of calcium caseinate, 30g of maltodextrin, and 0.2g of flavoring. The organoleptic characteristics and packaging were similar between treatments. Subjects were instructed to consume two packets per day, preferably with breakfast and dinner. The content of each packet (30g of product) was dissolved in 250-300ml of water.
Volunteers followed the given treatment for two consecutive months, during which two follow-up visits took place. Blood samples, anthropometric characteristics, and blood pressure were obtained in all visits.
Compliance to diet, placebo, and DP was assessed with 24-hour dietary recalls, 3-day dietary records, and with the number of empty packets returned on the corresponding visits.
- Conditions
- Hypercholesterolemia, Disease, Dyslipidemias
- Being tested
- Placebo, Dietary portfolio
- Keywords
- hypercholesterolemia, dietary portfolio, soy protein, LDL-C, lipoprotein subclasses, nopal, chia seed, functional foods
- Medical subject headings
- Hypercholesterolemia, Disease, Dyslipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDietary supplement
A mixture of maltodextrins and calcium caseinate divided into 30g individual packets.
Dietary portfolioDietary supplement
A mixture of functional foods divided into 30g individual packets.
| Study group | Role | What they receive |
|---|---|---|
| Placebo (P) | Placebo comparator | The placebo consisted of 30g of calcium caseinate, 30g of maltodextrin, and 0.2g of flavoring. The placebo was provided in a dehydrated form in a packet containing 30g each provided twice a day. The content of each packet was dissolved in 250ml of water. Receives: Dietary Supplement: Placebo |
| Dietary Portfolio (DP) | Experimental | The DP included 25g of soy protein, 14g of dehydrated nopal,14g of oats, 4g of chia seeds, 4g of inulin, and 0.15g of flavoring. The DP was provided in a dehydrated form in a packet containing 30g each. The content of each packet was dissolved in 250ml of water. Receives: Dietary Supplement: Dietary portfolio |
What is being measured
The primary outcome is the main question the study is designed to answer.
Low density lipoprotein- cholesterol (LDL-C)
Plasma total LDL-C (mg/dl)
Measured: Change in total LDL-C after 2.5 months of treatment
Lipoprotein subclasses
High density lipoprotein (HDL), low density lipoprotein (LDL), and very low density lipoprotein (VLDL) subclasses (small medium and large) as measure by nuclear magnetic resonance spectroscopy (NMR) in μmol/L.
Measured: Change in small, medium and large LDL, HDL and VLDL lipoprotein subclasses after 2.5 months of treatment
Secondary outcomes (7)
Total cholesterol
Plasma total cholesterol (mg/dL)
Measured: Change in total cholesterol after 2.5 months of treatment
Triglycerides
Plasma triglycerides (mg/dL)
Measured: Change in triglycerides after 2.5 months of treatment
High density lipoprotein cholesterol (HDL-C)
Plasma HDL cholesterol (mg/dL)
Measured: Change after 2.5 months of treatment
Apolipoprotein B
Change in apolipoprotein B in
Measured: Change after 2.5 months of treatment
Apolipoprotein A
Change in apolipoprotein A in plasma
Measured: Change after 2.5 months of treatment
Total/ high density lipoprotein cholesterol (HDL-C) ratio
Change in total/ high density lipoprotein cholesterol (HDL-C) ratio
Measured: Change after 2.5 months of treatment
Apolipoprotein B/Apolipoprotein A ratio
Change in Apolipoprotein B / Apolipoprotein A ratio
Measured: Change after 2.5 months of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2019
- Study start28 Feb 2013
- Primary completion18 Dec 2018
- Study completion18 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for 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
- Model description
- This study had two stages. In the first stage, subjects underwent dietary standardization with low saturated fat dietary treatments (LSFD) designed according to NCEP, ATP III criteria, and that provided the same amount of energy as that of the habitual diet of the volunteers, as assessed by 24-hour dietary recalls. In the second stage, subjects were randomly allocated to two different treatments, 1) LSFD plus placebo or, 2) LSFD plus dietary portfolio. Subjects were instructed to consume two packets of the corresponding treatment a day dissolved in 250-300 ml of water before breakfast and dinner for two consecutive months.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nimbe Torres y Torres, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
- Investigators
- Nimbe Torres y Torres, PhD, Principal investigator, INCMNSZ
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04148976
- Sponsor's protocol ID
- 706
- Status last verified
- Nov 2019
- First submitted
- 31 Oct 2019
- Last updated
- 6 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Guevara-Cruz M, Tovar AR, Aguilar-Salinas CA, Medina-Vera I, Gil-Zenteno L, Hernandez-Viveros I, Lopez-Romero P, Ordaz-Nava G, Canizales-Quinteros S, Guillen Pineda LE, Torres N. A dietary pattern including nopal, chia seed, soy protein, and oat reduces serum triglycerides and glucose intolerance in patients with metabolic syndrome. J Nutr. 2012 Jan;142(1):64-9. doi: 10.3945/jn.111.147447. Epub 2011 Nov 16.
PubMed 22090467Guevara-Cruz M, Flores-Lopez AG, Aguilar-Lopez M, Sanchez-Tapia M, Medina-Vera I, Diaz D, Tovar AR, Torres N. Improvement of Lipoprotein Profile and Metabolic Endotoxemia by a Lifestyle Intervention That Modifies the Gut Microbiota in Subjects With Metabolic Syndrome. J Am Heart Assoc. 2019 Sep 3;8(17):e012401. doi: 10.1161/JAHA.119.012401. Epub 2019 Aug 27.
PubMed 31451009Jenkins DJ, Josse AR, Wong JM, Nguyen TH, Kendall CW. The portfolio diet for cardiovascular risk reduction. Curr Atheroscler Rep. 2007 Dec;9(6):501-7. doi: 10.1007/s11883-007-0067-7.
PubMed 18377791Mora S, Otvos JD, Rifai N, Rosenson RS, Buring JE, Ridker PM. Lipoprotein particle profiles by nuclear magnetic resonance compared with standard lipids and apolipoproteins in predicting incident cardiovascular disease in women. Circulation. 2009 Feb 24;119(7):931-9. doi: 10.1161/CIRCULATIONAHA.108.816181. Epub 2009 Feb 9.
PubMed 19204302Torres N, Guevara-Cruz M, Granados J, Vargas-Alarcon G, Gonzalez-Palacios B, Ramos-Barragan VE, Quiroz-Olguin G, Flores-Islas IM, Tovar AR. Reduction of serum lipids by soy protein and soluble fiber is not associated with the ABCG5/G8, apolipoprotein E, and apolipoprotein A1 polymorphisms in a group of hyperlipidemic Mexican subjects. Nutr Res. 2009 Oct;29(10):728-35. doi: 10.1016/j.nutres.2009.09.013.
PubMed 19917453Ascencio C, Torres N, Isoard-Acosta F, Gomez-Perez FJ, Hernandez-Pando R, Tovar AR. Soy protein affects serum insulin and hepatic SREBP-1 mRNA and reduces fatty liver in rats. J Nutr. 2004 Mar;134(3):522-9. doi: 10.1093/jn/134.3.522.
PubMed 14988441Lopez-Romero P, Pichardo-Ontiveros E, Avila-Nava A, Vazquez-Manjarrez N, Tovar AR, Pedraza-Chaverri J, Torres N. The effect of nopal (Opuntia ficus indica) on postprandial blood glucose, incretins, and antioxidant activity in Mexican patients with type 2 diabetes after consumption of two different composition breakfasts. J Acad Nutr Diet. 2014 Nov;114(11):1811-8. doi: 10.1016/j.jand.2014.06.352. Epub 2014 Aug 12.
PubMed 25132122Medina-Vera I, Sanchez-Tapia M, Noriega-Lopez L, Granados-Portillo O, Guevara-Cruz M, Flores-Lopez A, Avila-Nava A, Fernandez ML, Tovar AR, Torres N. A dietary intervention with functional foods reduces metabolic endotoxaemia and attenuates biochemical abnormalities by modifying faecal microbiota in people with type 2 diabetes. Diabetes Metab. 2019 Apr;45(2):122-131. doi: 10.1016/j.diabet.2018.09.004. Epub 2018 Sep 25.
PubMed 30266575Vazquez-Manjarrez N, Guevara-Cruz M, Flores-Lopez A, Pichardo-Ontiveros E, Tovar AR, Torres N. Effect of a dietary intervention with functional foods on LDL-C concentrations and lipoprotein subclasses in overweight subjects with hypercholesterolemia: Results of a controlled trial. Clin Nutr. 2021 May;40(5):2527-2534. doi: 10.1016/j.clnu.2021.02.048. Epub 2021 Mar 6.
PubMed 33932799
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Dietary Intervention on LDL-C Levels and Lipoprotein Subclasses Distribution in Patients With Hypercholesterolemia
- ClinicalTrials.gov ID
- NCT04148976
- Acronym / sponsor ID
- 706
- Conditions
- Hypercholesterolemia, Disease, Dyslipidemias
- Keywords
- hypercholesterolemia, dietary portfolio, soy protein, LDL-C, lipoprotein subclasses, nopal, chia seed, functional foods
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Instituto Nacional de Ciencias Medicas y Nutricion Salvador ZubiranUniversity, hospital or other
- Study start
- 28 Feb 2013 (actual)
- Primary completion
- 18 Dec 2018 (actual)
- Study completion
- 18 Dec 2018 (actual)
- First posted
- 4 Nov 2019 (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.
The primary aim of the present study was to elucidate the effect of a combination of functional foods on the low-density lipoprotein cholesterol (LDL-C) levels and on the distribution of the lipoprotein subclasses in subjects with hypercholesterolemia. To accomplish the latter, subjects that met the inclusion criteria and had mild hypercholesterolemia (Total cholesterol >200mg/dL, and LDL-C >130mg/dL <190 mg/dL) were recruited for double-blind, parallel, controlled dietary intervention study. After two weeks of dietary standardization with an isocaloric diet, subjects were randomized and allocated to either placebo or a dietary portfolio treatment for two months. The secondary endpoints were the size of the different lipoprotein subclasses, total cholesterol levels, high density -lipoprotein cholesterol (HDL-C) levels, apolipoprotein B, triglycerides, total/HDL-C ratio, apolipoprotein B/apolipoprotein A ratio, and anthropometric measurements.
Detailed description
The present work took place at the Department of Physiology of Nutrition at the Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran (INCMNSZ). The study followed a randomized, controlled, double-blind, parallel design encompassing five visits. On the first visit, volunteers were screened for eligibility criteria. Subjects that met the inclusion criteria were then invited to a second visit. Herein, volunteers received a thorough explanation of the experimental maneuver, as well as the overall objectives of the study. Thereafter, subjects who agreed to participate signed a consent form.
Upon agreement, assessment of habitual dietary intake and physical activity was obtained by 24-hour dietary recalls, food frequency questionnaire (FFQ), and by the International Physical Activity Questionnaire (IPAQ), respectively. Additionally, anthropometric measurements and blood samples were registered and collected. Then, volunteers underwent dietary standardization for two weeks with isocaloric diets (LSFD), which followed the National Cholesterol Education Program (NCEP) , Adult Treatment Panel III (ATP III) criteria. That is, 50-60% carbohydrates, 15% protein, 25-35% fat,<7% saturated fat,≤ 200mg of dietary cholesterol, 20-35g of fiber, and 2000mg/d of sodium.
On the third visit, subjects were randomly allocated to either LSFD plus placebo or an LSFD plus the dietary portfolio (DP). Of note, the prescribed diets were matched to the volunteers' habitual caloric intake -considering the energy provided by the placebo or DP- to avoid variability of the endpoint variables due to weight-loss. The DP and placebo provided 200kcal; the DP included 25g of soy protein, 14g of dehydrated nopal,14g of oats, 4g of chia seeds, 4g of inulin, and 0.15g of flavoring. The placebo consisted of 30g of calcium caseinate, 30g of maltodextrin, and 0.2g of flavoring. The organoleptic characteristics and packaging were similar between treatments. Subjects were instructed to consume two packets per day, preferably with breakfast and dinner. The content of each packet (30g of product) was dissolved in 250-300ml of water.
Volunteers followed the given treatment for two consecutive months, during which two follow-up visits took place. Blood samples, anthropometric characteristics, and blood pressure were obtained in all visits.
Compliance to diet, placebo, and DP was assessed with 24-hour dietary recalls, 3-day dietary records, and with the number of empty packets returned on the corresponding visits.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- This study had two stages. In the first stage, subjects underwent dietary standardization with low saturated fat dietary treatments (LSFD) designed according to NCEP, ATP III criteria, and that provided the same amount of energy as that of the habitual diet of the volunteers, as assessed by 24-hour dietary recalls. In the second stage, subjects were randomly allocated to two different treatments, 1) LSFD plus placebo or, 2) LSFD plus dietary portfolio. Subjects were instructed to consume two packets of the corresponding treatment a day dissolved in 250-300 ml of water before breakfast and dinner for two consecutive months.
| Arm | Type | Receives |
|---|---|---|
| Placebo (P) | Placebo comparator | Dietary Supplement: PlaceboThe placebo consisted of 30g of calcium caseinate, 30g of maltodextrin, and 0.2g of flavoring. The placebo was provided in a dehydrated form in a packet containing 30g each provided twice a day. The content of each packet was dissolved in 250ml of water. |
| Dietary Portfolio (DP) | Experimental | Dietary Supplement: Dietary portfolioThe DP included 25g of soy protein, 14g of dehydrated nopal,14g of oats, 4g of chia seeds, 4g of inulin, and 0.15g of flavoring. The DP was provided in a dehydrated form in a packet containing 30g each. The content of each packet was dissolved in 250ml of water. |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Men and women
- Body mass index (BMI) 25 to ≤ 39.9 kg/m2
- Adults between 20 and 60 years of age
- Total cholesterol levels of >200mg/dL in serum
- LDL-C levels ≥130mg/dL ≤190mg/dL
Key exclusion criteria (11 listed)
- Subjects with diabetes
- Diseases that produce obesity or diabetes
- Cardiovascular events
- Weight-loss of ≥ 3kg on the preceding months to the study
- Catabolic diseases such as cancer and acquired immunodeficiency syndrome
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 |
|---|---|---|
| PlaceboA mixture of maltodextrins and calcium caseinate divided into 30g individual packets. | Dietary supplement | Placebo (P) |
| Dietary portfolioA mixture of functional foods divided into 30g individual packets. | Dietary supplement | Dietary Portfolio (DP) |
Primary outcome
Low density lipoprotein- cholesterol (LDL-C)
Time frame: Change in total LDL-C after 2.5 months of treatment
Plasma total LDL-C (mg/dl)
Lipoprotein subclasses
Time frame: Change in small, medium and large LDL, HDL and VLDL lipoprotein subclasses after 2.5 months of treatment
High density lipoprotein (HDL), low density lipoprotein (LDL), and very low density lipoprotein (VLDL) subclasses (small medium and large) as measure by nuclear magnetic resonance spectroscopy (NMR) in μmol/L.
7 secondary outcomes
Total cholesterol
Time frame: Change in total cholesterol after 2.5 months of treatment
Triglycerides
Time frame: Change in triglycerides after 2.5 months of treatment
High density lipoprotein cholesterol (HDL-C)
Time frame: Change after 2.5 months of treatment
Apolipoprotein B
Time frame: Change after 2.5 months of treatment
Apolipoprotein A
Time frame: Change after 2.5 months of treatment
Total/ high density lipoprotein cholesterol (HDL-C) ratio
Time frame: Change after 2.5 months of treatment
Apolipoprotein B/Apolipoprotein A ratio
Time frame: Change after 2.5 months of treatment
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 6 Nov 2019.
- Background: PubMed 22090467Guevara-Cruz M, Tovar AR, Aguilar-Salinas CA, Medina-Vera I, Gil-Zenteno L, Hernandez-Viveros I, Lopez-Romero P, Ordaz-Nava G, Canizales-Quinteros S, Guillen Pineda LE, Torres N. A dietary pattern including nopal, chia seed, soy protein, and oat reduces serum triglycerides and glucose intolerance in patients with metabolic syndrome. J Nutr. 2012 Jan;142(1):64-9. doi: 10.3945/jn.111.147447. Epub 2011 Nov 16.
- Background: PubMed 31451009Guevara-Cruz M, Flores-Lopez AG, Aguilar-Lopez M, Sanchez-Tapia M, Medina-Vera I, Diaz D, Tovar AR, Torres N. Improvement of Lipoprotein Profile and Metabolic Endotoxemia by a Lifestyle Intervention That Modifies the Gut Microbiota in Subjects With Metabolic Syndrome. J Am Heart Assoc. 2019 Sep 3;8(17):e012401. doi: 10.1161/JAHA.119.012401. Epub 2019 Aug 27.
- Background: PubMed 18377791Jenkins DJ, Josse AR, Wong JM, Nguyen TH, Kendall CW. The portfolio diet for cardiovascular risk reduction. Curr Atheroscler Rep. 2007 Dec;9(6):501-7. doi: 10.1007/s11883-007-0067-7.
- Background: PubMed 19204302Mora S, Otvos JD, Rifai N, Rosenson RS, Buring JE, Ridker PM. Lipoprotein particle profiles by nuclear magnetic resonance compared with standard lipids and apolipoproteins in predicting incident cardiovascular disease in women. Circulation. 2009 Feb 24;119(7):931-9. doi: 10.1161/CIRCULATIONAHA.108.816181. Epub 2009 Feb 9.
- Background: PubMed 19917453Torres N, Guevara-Cruz M, Granados J, Vargas-Alarcon G, Gonzalez-Palacios B, Ramos-Barragan VE, Quiroz-Olguin G, Flores-Islas IM, Tovar AR. Reduction of serum lipids by soy protein and soluble fiber is not associated with the ABCG5/G8, apolipoprotein E, and apolipoprotein A1 polymorphisms in a group of hyperlipidemic Mexican subjects. Nutr Res. 2009 Oct;29(10):728-35. doi: 10.1016/j.nutres.2009.09.013.
- Background: PubMed 14988441Ascencio C, Torres N, Isoard-Acosta F, Gomez-Perez FJ, Hernandez-Pando R, Tovar AR. Soy protein affects serum insulin and hepatic SREBP-1 mRNA and reduces fatty liver in rats. J Nutr. 2004 Mar;134(3):522-9. doi: 10.1093/jn/134.3.522.
- Background: PubMed 25132122Lopez-Romero P, Pichardo-Ontiveros E, Avila-Nava A, Vazquez-Manjarrez N, Tovar AR, Pedraza-Chaverri J, Torres N. The effect of nopal (Opuntia ficus indica) on postprandial blood glucose, incretins, and antioxidant activity in Mexican patients with type 2 diabetes after consumption of two different composition breakfasts. J Acad Nutr Diet. 2014 Nov;114(11):1811-8. doi: 10.1016/j.jand.2014.06.352. Epub 2014 Aug 12.
- Background: PubMed 30266575Medina-Vera I, Sanchez-Tapia M, Noriega-Lopez L, Granados-Portillo O, Guevara-Cruz M, Flores-Lopez A, Avila-Nava A, Fernandez ML, Tovar AR, Torres N. A dietary intervention with functional foods reduces metabolic endotoxaemia and attenuates biochemical abnormalities by modifying faecal microbiota in people with type 2 diabetes. Diabetes Metab. 2019 Apr;45(2):122-131. doi: 10.1016/j.diabet.2018.09.004. Epub 2018 Sep 25.
- Derived from this study: PubMed 33932799Vazquez-Manjarrez N, Guevara-Cruz M, Flores-Lopez A, Pichardo-Ontiveros E, Tovar AR, Torres N. Effect of a dietary intervention with functional foods on LDL-C concentrations and lipoprotein subclasses in overweight subjects with hypercholesterolemia: Results of a controlled trial. Clin Nutr. 2021 May;40(5):2527-2534. doi: 10.1016/j.clnu.2021.02.048. Epub 2021 Mar 6.
- Individual participant dataSharing planned: No
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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.
Nimbe Torres y Torres, PhD principal investigator
INCMNSZ
Questions about this trial
What is this clinical trial studying?
A study testing Dietary portfolio in people with Hypercholesterolemia and Disease, run by Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran.
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 7 inclusion and 11 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 6 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
Low density lipoprotein- cholesterol (LDL-C) (time frame: Change in total LDL-C after 2.5 months of treatment). The study lists 2 primary outcomes in all. 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 NCT04148976, which also lists 9 linked publications.
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 6 Nov 2019.