Effect of Acute Fructose Load in Human

NCT03157960 | Completed

• 1 other identifier: 2011/1183-31/2
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The metabolism of the monosaccharide fructose is less controlled than the metabolism of glucose, which will result in the metabolic product uric acid. Elevated serum uric acid levels are associated with increased risk, or worsening, of chronic kidney disease. The mechanisms by which uric acid have detrimental effects are not well defined, but may include an increase in reactive oxygen species and subsequent inflammatory activity. The aim of this study is to investigate the effects of uric acid, markers of oxidative stress and markers of inflammation following a low fructose load reflecting normal conditions. This is an interventional study. On six different occasions patients with chronic kidney disease, patients with type 2 diabetes and healthy controls will receive Blueberry drink, Coca-Cola or pure Fructose drink with similar amount of carbohydrates (140 kcal) with and without a high fat meal represented by a pizza (425 kcal).Serum samples and urinary samples will be collected.

Conditions

Chronic Kidney Diseases; Diabetes Mellitus, Type 2

Keywords

Fructose; Uric acid; Oxidised LDL; Interleukin 6

Outcome Measures

Primary Outcomes (1)

• Changes in uric acid (µmol/L)

  Change in uric acid after intervention compared to the levels Before the intervention

  2 hours for only drink and 4 hours for drink and a high fat meal

Study Arms (6)

Blueberry drink

EXPERIMENTAL

Participant will receive a blueberry drink containing 18 g of fructose and 14 g of glucose.

Other: Blueberry drink

Blueberry and pizza

EXPERIMENTAL

Participant will receive a blueberry drink and a slice of pizza (170 grams; 22 g protein, 20 g fat and 50 g carbohydrate; 425 kCal)

Other: Blueberry and pizza

Soft beverage

EXPERIMENTAL

Participant will receive a Soft beverage (Coca-cola containing 17,5 g fructose and 17,5 g glucose)

Other: Soft beverage

Soft beverage and pizza

EXPERIMENTAL

Participant will receive a Soft beverage and a slice of pizza (170 grams; 22 g protein, 20 g fat and 50 g carbohydrate; 425 kCal)

Other: Soft beverage and pizza

Fructose

EXPERIMENTAL

Participant will receive a drink containing 35 g of fructose

Other: Fructose

Fructose and pizza

EXPERIMENTAL

Participant will receive a drink containing 35 g of fructose and a slice of pizza (170 grams; 22 g protein, 20 g fat and 50 g carbohydrate; 425 kCal)

Other: Fructose and pizza

Interventions

Blueberry drink OTHER

Participant receive blueberry drink

Blueberry drink

Blueberry and pizza OTHER

Participant receive blueberry drink and a slice of pizza

Blueberry and pizza

Soft beverage OTHER

Participant receive a soft beverage drink

Soft beverage

Soft beverage and pizza OTHER

Participant receive a soft beverage drink and a slice of pizza

Soft beverage and pizza

Fructose OTHER

Participant receive a drink containing fructose

Fructose

Fructose and pizza OTHER

Participant receive a fructose drink and a slice of pizza

Fructose and pizza

Eligibility Criteria

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

You may qualify if:

• GFR \<30 ml/min or \>3 months of dialysis for patients with CKD
• Patients with type 2 diabetes with and without CKD
• Controls without diabetes type 2 or CKD

You may not qualify if:

• HbA1c \> 100 mmol/mol.
• Signs of fluid overload
• Inability to understand the information provided for the study.
• Ongoing inflammatory disease or infection,
• Treatment with allopurinol or other uric acid lowering agents a

Sponsors & Collaborators

• Karolinska University Hospital: lead

Study Sites (1)

Karolinska University Hospital

Stockholm, 17176, Sweden

Location

Related Publications (21)

• Kolderup A, Svihus B. Fructose Metabolism and Relation to Atherosclerosis, Type 2 Diabetes, and Obesity. J Nutr Metab. 2015;2015:823081. doi: 10.1155/2015/823081. Epub 2015 Jun 14.

  PMID: 26199742 BACKGROUND

• Tappy L, Le KA. Metabolic effects of fructose and the worldwide increase in obesity. Physiol Rev. 2010 Jan;90(1):23-46. doi: 10.1152/physrev.00019.2009.

  PMID: 20086073 BACKGROUND

• Dyer J, Wood IS, Palejwala A, Ellis A, Shirazi-Beechey SP. Expression of monosaccharide transporters in intestine of diabetic humans. Am J Physiol Gastrointest Liver Physiol. 2002 Feb;282(2):G241-8. doi: 10.1152/ajpgi.00310.2001.

  PMID: 11804845 BACKGROUND

• Bjornstad P, Lanaspa MA, Ishimoto T, Kosugi T, Kume S, Jalal D, Maahs DM, Snell-Bergeon JK, Johnson RJ, Nakagawa T. Fructose and uric acid in diabetic nephropathy. Diabetologia. 2015 Sep;58(9):1993-2002. doi: 10.1007/s00125-015-3650-4. Epub 2015 Jun 7.

  PMID: 26049401 BACKGROUND

• Mayes PA. Intermediary metabolism of fructose. Am J Clin Nutr. 1993 Nov;58(5 Suppl):754S-765S. doi: 10.1093/ajcn/58.5.754S.

  PMID: 8213607 BACKGROUND

• Jia G, Aroor AR, Whaley-Connell AT, Sowers JR. Fructose and uric acid: is there a role in endothelial function? Curr Hypertens Rep. 2014 Jun;16(6):434. doi: 10.1007/s11906-014-0434-z.

  PMID: 24760443 BACKGROUND

• Feig DI, Kang DH, Johnson RJ. Uric acid and cardiovascular risk. N Engl J Med. 2008 Oct 23;359(17):1811-21. doi: 10.1056/NEJMra0800885. No abstract available.

  PMID: 18946066 BACKGROUND

• Hovind P, Rossing P, Johnson RJ, Parving HH. Serum uric acid as a new player in the development of diabetic nephropathy. J Ren Nutr. 2011 Jan;21(1):124-7. doi: 10.1053/j.jrn.2010.10.024.

  PMID: 21195935 BACKGROUND

• Riegersperger M, Covic A, Goldsmith D. Allopurinol, uric acid, and oxidative stress in cardiorenal disease. Int Urol Nephrol. 2011 Jun;43(2):441-9. doi: 10.1007/s11255-011-9929-6. Epub 2011 Mar 10.

  PMID: 21547469 BACKGROUND

• Soltani Z, Rasheed K, Kapusta DR, Reisin E. Potential role of uric acid in metabolic syndrome, hypertension, kidney injury, and cardiovascular diseases: is it time for reappraisal? Curr Hypertens Rep. 2013 Jun;15(3):175-81. doi: 10.1007/s11906-013-0344-5.

  PMID: 23588856 BACKGROUND

• Shaw JE, Sicree RA, Zimmet PZ. Global estimates of the prevalence of diabetes for 2010 and 2030. Diabetes Res Clin Pract. 2010 Jan;87(1):4-14. doi: 10.1016/j.diabres.2009.10.007. Epub 2009 Nov 6.

  PMID: 19896746 BACKGROUND

• Zhang P, Zhang X, Brown J, Vistisen D, Sicree R, Shaw J, Nichols G. Global healthcare expenditure on diabetes for 2010 and 2030. Diabetes Res Clin Pract. 2010 Mar;87(3):293-301. doi: 10.1016/j.diabres.2010.01.026. Epub 2010 Feb 19.

  PMID: 20171754 BACKGROUND

• Davies MJ, Tringham JR, Troughton J, Khunti KK. Prevention of Type 2 diabetes mellitus. A review of the evidence and its application in a UK setting. Diabet Med. 2004 May;21(5):403-14. doi: 10.1111/j.1464-5491.2004.01176.x.

  PMID: 15089783 BACKGROUND

• Singh DK, Winocour P, Farrington K. Oxidative stress in early diabetic nephropathy: fueling the fire. Nat Rev Endocrinol. 2011 Mar;7(3):176-84. doi: 10.1038/nrendo.2010.212. Epub 2010 Dec 14.

  PMID: 21151200 BACKGROUND

• Shields J, Maxwell AP. Managing diabetic nephropathy. Clin Med (Lond). 2010 Oct;10(5):500-4. doi: 10.7861/clinmedicine.10-5-500.

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• Forbes JM, Cooper ME. Mechanisms of diabetic complications. Physiol Rev. 2013 Jan;93(1):137-88. doi: 10.1152/physrev.00045.2011.

  PMID: 23303908 BACKGROUND

• Afghahi H, Cederholm J, Eliasson B, Zethelius B, Gudbjornsdottir S, Hadimeri H, Svensson MK. Risk factors for the development of albuminuria and renal impairment in type 2 diabetes--the Swedish National Diabetes Register (NDR). Nephrol Dial Transplant. 2011 Apr;26(4):1236-43. doi: 10.1093/ndt/gfq535. Epub 2010 Sep 3.

  PMID: 20817668 BACKGROUND

• van Dijk C, Berl T. Pathogenesis of diabetic nephropathy. Rev Endocr Metab Disord. 2004 Aug;5(3):237-48. doi: 10.1023/B:REMD.0000032412.91984.ec. No abstract available.

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• Ahmad J. Management of diabetic nephropathy: Recent progress and future perspective. Diabetes Metab Syndr. 2015 Oct-Dec;9(4):343-58. doi: 10.1016/j.dsx.2015.02.008. Epub 2015 Mar 6.

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  PMID: 24357208 BACKGROUND

• O'Keefe JH, Gheewala NM, O'Keefe JO. Dietary strategies for improving post-prandial glucose, lipids, inflammation, and cardiovascular health. J Am Coll Cardiol. 2008 Jan 22;51(3):249-55. doi: 10.1016/j.jacc.2007.10.016.

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MeSH Terms

Conditions

Renal Insufficiency, Chronic; Diabetes Mellitus, Type 2

Interventions

blueberry extract; Carbonated Beverages; Fructose

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Beverages; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Hexoses; Monosaccharides; Sugars; Carbohydrates; Ketoses

Study Officials

• Peter Stenvinkel, professor

  Karolinska University Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D.,Ph.D

Model Details: Interventional study. Participant will on sex different occasions receive drinks containing fructose (fructose drink, coca-cola or blueberry drink) with and without the addition of a high-fat meal

Study Record Dates

• First Submitted: May 16, 2017
• First Posted: May 17, 2017
• Study Start: February 1, 2012
• Primary Completion: November 30, 2019
• Study Completion: November 30, 2021
• Last Updated: February 22, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)