NCT02894931

Brief Summary

While previous atherosclerosis-related studies have focused mainly on the atherogenicity of lipids, the proposed study aims to investigate the effects of other dietary factors, i.e. monosaccharides, disaccharides, amino acids, or artificial sweeteners, on the atherogenicity of serum or macrophages. Findings from the current proposed study may shed light on yet unknown mechanisms by which the above dietary factors could affect atherosclerosis development and CVD risk and hence could possibly assist in the future development of anti-atherogenic strategies.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 22, 2016

Completed
10 days until next milestone

Study Start

First participant enrolled

September 1, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 9, 2016

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2018

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2018

Completed
Last Updated

September 27, 2016

Status Verified

September 1, 2016

Enrollment Period

1.7 years

First QC Date

August 22, 2016

Last Update Submit

September 26, 2016

Conditions

Dietary HabitsSerum; DiseaseMacrophage AtherogenicityAtherosclerosis

Keywords

macrophage atherogenicitydietary interventionssugarsamino acidsartificial sweetenersatherosclerosis

Outcome Measures

Primary Outcomes (2)

  • serum Oxidation dietary factors, i.e. monosaccharides, disaccharides, amino acids, or artificial atherogenicity of serum

    serum oxidation level; TBARS (nmol MDA /ml)

    2 years

  • macrophages cellular Oxidation.

    oxidation level; TBARS (nmol MDA /mg protein)

    2 years

Secondary Outcomes (4)

  • Serum lipids- Cholesterol

    2 years

  • Serum lipids- Triglycerides

    2 years

  • macrophages cellular lipids- Cholesterol

    2 years

  • macrophages cellular lipids -Triglycerides

    2 years

Study Arms (15)

Control

SHAM COMPARATOR

Dietary Interventions: Control- water, Flavered Chilled water, will be administered once after O.N fasting.

Other: Control- water

Glucose

ACTIVE COMPARATOR

Dietary Interventions: Glucose, Monosaccharides, at the dose of 50 g, based on oral loading tests, once.

Dietary Supplement: monosaccharides

Fructose

EXPERIMENTAL

Dietary Interventions: Fructose, Monosaccharides, at the dose of 50 g, once.

Dietary Supplement: monosaccharides

Galactose

EXPERIMENTAL

Dietary Interventions: Monosaccharides, at the dose of 50 g, once.

Dietary Supplement: monosaccharides

Mannose

EXPERIMENTAL

Dietary Interventions: Monosaccharides, at the dose of 50 g, once.

Dietary Supplement: monosaccharides

Maltose

EXPERIMENTAL

Dietary Interventions: The dose of the disaccharides - 50 g, once.

Dietary Supplement: Disaccharides

Sucrose

EXPERIMENTAL

Dietary Interventions: The dose of the disaccharides - 50 g, once.

Dietary Supplement: Disaccharides

Lactose

EXPERIMENTAL

Dietary Interventions: The dose of the disaccharides - 50 g, once.

Dietary Supplement: Disaccharides

Saccharin

EXPERIMENTAL

Dietary Interventions: The dose of the different artificial sweeteners - 300 mg, is based on an average adult male body weight of 75 kg and is set not to exceed the acceptable daily intakes of saccharin, aspartame, sucralose and steviol that were reported at 15, 50, 5, and 4 mg/kg body weight/day by the USA Food and Drug Administration, once.

Dietary Supplement: Artificial Sweeteners

Aspartame

EXPERIMENTAL

Dietary Interventions: The dose of the different artificial sweeteners - 300 mg, is based on an average adult male body weight of 75 kg and is set not to exceed the acceptable daily intakes of saccharin, aspartame, sucralose and steviol that were reported at 15, 50, 5, and 4 mg/kg body weight/day by the USA Food and Drug Administration, once.

Dietary Supplement: Artificial Sweeteners

Sucralose

EXPERIMENTAL

Dietary Interventions: The dose of the different artificial sweeteners - 300 mg, is based on an average adult male body weight of 75 kg and is set not to exceed the acceptable daily intakes of saccharin, aspartame, sucralose and steviol that were reported at 15, 50, 5, and 4 mg/kg body weight/day by the USA Food and Drug Administration, once.

Dietary Supplement: Artificial Sweeteners

Steviol

EXPERIMENTAL

Dietary Interventions: The dose of the different artificial sweeteners - 300 mg, is based on an average adult male body weight of 75 kg and is set not to exceed the acceptable daily intakes of saccharin, aspartame, sucralose and steviol that were reported at 15, 50, 5, and 4 mg/kg body weight/day by the USA Food and Drug Administration, once.

Dietary Supplement: Artificial Sweeteners

Leucine

EXPERIMENTAL

Dietary Interventions: The dose of the different BCAAs Amino acids- 5 g, is set not to exceed the mean daily intakes of leucine, isoleucine and valine for adult males that were reported at 8.64, 5.01 and 5.63 g/day, respectively, once.

Dietary Supplement: Amino acids

Isoleucine

EXPERIMENTAL

Dietary Interventions: The dose of the different BCAAs Amino acids - 5 g, is set not to exceed the mean daily intakes of leucine, isoleucine and valine for adult males that were reported at 8.64, 5.01 and 5.63 g/day, respectively, once.

Dietary Supplement: Amino acids

Valine

EXPERIMENTAL

Dietary Interventions: The dose of the different BCAAs Amino acids- 5 g, is set not to exceed the mean daily intakes of leucine, isoleucine and valine for adult males that were reported at 8.64, 5.01 and 5.63 g/day, respectively, once.

Dietary Supplement: Amino acids

Interventions

monosaccharidesDIETARY_SUPPLEMENT

The monosaccharides; Glucose, Fructose, Galactose and mannose, will be administrated after O.N fasting, 50gr, once.

FructoseGalactoseGlucoseMannose
DisaccharidesDIETARY_SUPPLEMENT

The Disaccharides; Lactose, Maltose and sucrose, will be administrated after O.N fasting, 50gr, once.

LactoseMaltoseSucrose
Amino acidsDIETARY_SUPPLEMENT

The Amino acids; Leucine, Isoleucine, and Valine, will be administrated after O.N fasting, 5g, once.

IsoleucineLeucineValine
Artificial SweetenersDIETARY_SUPPLEMENT

The Artificial sweeteners: Saccharin, Aspartame, Sucralose and Steviol, will be administrated after O.N fasting, 300 mg, once.

AspartameSaccharinSteviolSucralose
Control- waterOTHER

Chilled water flavored with lemon juice as control

Control

Eligibility Criteria

Age18 Years - 50 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rambam Health care center

Haifa, Haifa District, 320000, Israel

RECRUITING

Related Publications (11)

  • Michas G, Micha R, Zampelas A. Dietary fats and cardiovascular disease: putting together the pieces of a complicated puzzle. Atherosclerosis. 2014 Jun;234(2):320-8. doi: 10.1016/j.atherosclerosis.2014.03.013. Epub 2014 Mar 27.

    PMID: 24727233BACKGROUND

  • Dickhout JG, Basseri S, Austin RC. Macrophage function and its impact on atherosclerotic lesion composition, progression, and stability: the good, the bad, and the ugly. Arterioscler Thromb Vasc Biol. 2008 Aug;28(8):1413-5. doi: 10.1161/ATVBAHA.108.169144. No abstract available.

    PMID: 18650503BACKGROUND

  • Bornfeldt KE, Tabas I. Insulin resistance, hyperglycemia, and atherosclerosis. Cell Metab. 2011 Nov 2;14(5):575-85. doi: 10.1016/j.cmet.2011.07.015.

    PMID: 22055501BACKGROUND

  • Huang Y, Zhou M, Sun H, Wang Y. Branched-chain amino acid metabolism in heart disease: an epiphenomenon or a real culprit? Cardiovasc Res. 2011 May 1;90(2):220-3. doi: 10.1093/cvr/cvr070.

    PMID: 21502372BACKGROUND

  • Shah SH, Bain JR, Muehlbauer MJ, Stevens RD, Crosslin DR, Haynes C, Dungan J, Newby LK, Hauser ER, Ginsburg GS, Newgard CB, Kraus WE. Association of a peripheral blood metabolic profile with coronary artery disease and risk of subsequent cardiovascular events. Circ Cardiovasc Genet. 2010 Apr;3(2):207-14. doi: 10.1161/CIRCGENETICS.109.852814. Epub 2010 Feb 19.

    PMID: 20173117BACKGROUND

  • Bhattacharya S, Granger CB, Craig D, Haynes C, Bain J, Stevens RD, Hauser ER, Newgard CB, Kraus WE, Newby LK, Shah SH. Validation of the association between a branched chain amino acid metabolite profile and extremes of coronary artery disease in patients referred for cardiac catheterization. Atherosclerosis. 2014 Jan;232(1):191-6. doi: 10.1016/j.atherosclerosis.2013.10.036. Epub 2013 Nov 12.

    PMID: 24401236BACKGROUND

  • Yang RY, Wang SM, Sun L, Liu JM, Li HX, Sui XF, Wang M, Xiu HL, Wang S, He Q, Dong J, Chen WX. Association of branched-chain amino acids with coronary artery disease: A matched-pair case-control study. Nutr Metab Cardiovasc Dis. 2015 Oct;25(10):937-42. doi: 10.1016/j.numecd.2015.06.003. Epub 2015 Jun 14.

    PMID: 26231617BACKGROUND

  • Yang R, Dong J, Zhao H, Li H, Guo H, Wang S, Zhang C, Wang S, Wang M, Yu S, Chen W. Association of branched-chain amino acids with carotid intima-media thickness and coronary artery disease risk factors. PLoS One. 2014 Jun 9;9(6):e99598. doi: 10.1371/journal.pone.0099598. eCollection 2014.

    PMID: 24910999BACKGROUND

  • Swithers SE. Artificial sweeteners produce the counterintuitive effect of inducing metabolic derangements. Trends Endocrinol Metab. 2013 Sep;24(9):431-41. doi: 10.1016/j.tem.2013.05.005. Epub 2013 Jul 10.

    PMID: 23850261BACKGROUND

  • Fung TT, Malik V, Rexrode KM, Manson JE, Willett WC, Hu FB. Sweetened beverage consumption and risk of coronary heart disease in women. Am J Clin Nutr. 2009 Apr;89(4):1037-42. doi: 10.3945/ajcn.2008.27140. Epub 2009 Feb 11.

    PMID: 19211821BACKGROUND

  • Rom O, Aviram M. Endogenous or exogenous antioxidants vs. pro-oxidants in macrophage atherogenicity. Curr Opin Lipidol. 2016 Apr;27(2):204-6. doi: 10.1097/MOL.0000000000000287. No abstract available.

    PMID: 26959710RESULT

MeSH Terms

Conditions

Feeding BehaviorDiseaseAtherosclerosis

Interventions

MonosaccharidesDisaccharidesAmino AcidsSweetening Agents

Condition Hierarchy (Ancestors)

Behavior, AnimalBehaviorPathologic ProcessesPathological Conditions, Signs and SymptomsArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

SugarsCarbohydratesOligosaccharidesPolysaccharidesAmino Acids, Peptides, and ProteinsFlavoring AgentsFood AdditivesFood IngredientsSpecialty Uses of ChemicalsChemical Actions and UsesFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Tony Hayek, Prof.

    Rambam Health care center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Niroz Abu-Saleh Zoabi, PhD

CONTACT

+972-50-4728858asniroz@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, Department of Internal Medicine E

Study Record Dates

First Submitted

August 22, 2016

First Posted

September 9, 2016

Study Start

September 1, 2016

Primary Completion

May 1, 2018

Study Completion

August 1, 2018

Last Updated

September 27, 2016

Record last verified: 2016-09

Locations

IL(1)