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Chronic Kidney DiseasesNCT03157960

Effect of Acute Fructose Load in Human

A study testing Blueberry drink, Blueberry and pizza and Soft beverage in people with Chronic Kidney Diseases and Diabetes Mellitus, Type 2, run by Karolinska University Hospital at 1 site in Sweden.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 yearsHealthy volunteers can take part
What is being tested?
Blueberry drink, Blueberry and pizza and Soft beverage
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteSweden
Study dates
1 Feb 2012to 30 Nov 2021
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 18 to 75 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Sweden1 site
  • Karolinska University Hospital

    Stockholm, 17176

Other trials in Sweden

About this study

Official title: The Effect of Acute Fructose Load in Patients With Chronic Kidney Disease and Patients With Type 2 Diabetes Compared to Healthy Subjects

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.

Read the detailed description

Fructose is a monosaccharide present naturally in foods as fruit, vegetables and honey. In fruit, vegetables and table sugar it is also present as a disaccharide (sucrose), where it is joined with glucose. The intake of fructose has increased dramatically in the last decades. The increase is attributed to the use of free fructose as a sweetener at higher concentrations than naturally occurring in food, where beverages as soft-drinks seem to be the largest contributor to present consumption. Fructose has a low glycemic index and thus helps maintain glycemic control, a property that led to the belief that it was beneficial as a sweetener for those with diabetes.

The body's capacity of absorbing fructose is limited and varies depending on age, health and co-ingested foods. Glucose is the dietary factor that has largest impact on fructose absorption, but animal studies also indicate that saturated fat increase absorption. It has been observed that the maximum fructose absorbing capacity varies between 5 and 50 g when consumed as a single dose. Individuals with type 2 diabetes seems to have a larger capacity to absorb fructose and they have higher levels of fructose in serum and urine when compared to those without diabetes.

Fructose is absorbed in the small intestine by the fructose specific transporter GLUT5. It is further transported to the liver through the portal vein, where it is absorbed and metabolized by liver cells. The metabolism of fructose is independent of insulin. Although some fructose is metabolized by the enterocytes in the small intestine, the liver metabolize the majority of ingested fructose, in comparison to about 15-30% of ingested glucose. The metabolism of fructose differs from glucose in the sense that it is less controlled. While glucose metabolism is regulated by the energy status of the cell and portal glucose concentrations, fructose metabolism lacks control mechanisms leading to different metabolic products and effects.

In the metabolic pathway fructose can be oxidized, converted to glucose or lactic acid, or enter de novo lipogenesis. In the first hepatic metabolic step fructose is phosphorylated by fructokinase, a fructose specific enzyme with high activity, to fructose-1-phosphate. Fructokinase is not regulated by the energy status (ATP) of the cell, and fructose will therefore be metabolized in an unlimited way. This is in contrast to steps in the glycolysis where phosphofructokinase is regulated by ATP. Due to the rapid phosphorylation of fructose, levels of ATP will be depleted followed by an increase in uric acid. An increase in reactive oxygen species will follow the formation of uric acid which may lead to inflammation in the endothelium and inflammatory activity in adipocytes. Animal models show that uric acid may also act directly on tubular cells in the kidney where it causes inflammation. Serum uric acid levels are moreover positively associated with renin activity and hypertension. Further, as fructose is metabolized in a less controlled way than glucose, a larger proportion of fructose is available for de novo lipogenesis (DNL). This may be due to that the capacity of the mitochondria is exceeded and acetyl-Coenzyme A will enter DNL instead of the citric acid cycle. This metabolic effect of glucose is considered as "particularly harmful". Whether glucose is co-ingested with fructose or not may have an impact on the metabolic effects as there will be an effect of secreted insulin. Insulin decreases production of glucose from fructose and stimulates the de novo lipogenesis pathway.

The increase in fructose consumption correlates closely with the rise in obesity, metabolic syndrome and diabetes. Long term consumption of fructose has been shown to cause increased uric acid in the body. Elevated serum uric acid levels are associated with risk of chronic kidney disease both among healthy subject and among those with diabetes. Among those with type 2 diabetes it has also been associated with progression of already established nephropathy.

It is estimated that 7.3 % of the adult population in Sweden is affected by diabetes and that the majority, 85 -90 %, constitutes of type 2 diabetes (T2D). T2D is considered to be one of the most common chronic diseases and the prevalence is expected to rise, and with that an increasing health and economic burden. Worldwide patterns indicate a growing burden as well, particularly in developing countries. T2D is a disease with multifactorial etiology and with complications such as cardiovascular and renal disease, blindness and amputation. Not only does diabetes affect quality of life, it also leads to premature death as life expectancy is reduced with as much as 15 years.

Diabetic nephropathy (DN) has become the most common cause of end-stage renal disease and the earliest sign of DN is presence of microalbuminuria. Further development of macroalbuminuria and a decline in glomerular filtration rate may follow. Among type 2 diabetics in Sweden it was observed that 20% developed albuminuria over the course of 5 years, and 11% developed renal impairment glomerular filtration rate (eGFR of < 60 mL/min/1.73m2, MDRD formula). Studies indicate that increased oxidative stress through different pathways may play a central role in the development of DN, and chronic hyperglycemia is the primary cause. But there are also other factors that increase oxidative stress and have an impact on development of renal disease, as for example free fatty acids and inflammation. The oxidative stress may cause damage to the renal milieu, as dysfunction of the endothelial cells within glomeruli and tissue injury of the tubule.

Factors related to disease management, as glycemic-, blood pressure- and lipid-control are important in protecting the kidney. Further, smoking cessation, energy balance for a healthy bodyweight and a healthy eating pattern are of importance. In regards of dietary composition, hyperglycemia and dyslipidemia is determined by the amount and quality of ingested carbohydrates and dietary fats. It has been suggested that postprandial hyperglycemia and hypertriglyceridemia triggers oxidative stress and causes inflammation, metabolic alterations associated with endothelial dysfunction. A prospective cohort conducted in 10 European countries, including Sweden (Malmö and Umeå) showed a protective effect of intake of vegetables, fruit and legumes against all-cause and cardiovascular mortality among those with diabetes. Possible mechanism is hypothesized to be attributed to the antioxidative properties. The anti-antioxidant and anti-inflammatory capacities of fruit and vegetables are mentioned as possible mechanisms.

Current Swedish dietary recommendation for diabetic's state that different diets as the Mediterranean and low carbohydrate diet etc. may be beneficial, while the scientific evidence for extremely low carbohydrate diet is yet too weak. They further state that single foods as fruit lower all-cause mortality and vegetables lowers the risk of cardiovascular mortality. Fructose is not discussed in the Swedish dietary recommendations. The American Diabetes Associations dietary recommendations do, however, state that fructose-containing beverages should be avoided due to its impact on metabolic profile.

The scientific evidence for the significance of diet on microvascular complications as kidney disease is scarce and there is a lack of studies on the effect of fruit and vegetables on diabetic nephropathy. This was also stated by Swedish Council on Health Technology Assessment (SBU) in a report published in 2010. SBU further emphasized the lack of dietary studies applicable to conditions in Sweden. Thus, considering the burden of type 2 diabetes and its related complications, the need for proposed studies is substantiate.

The overall aim of this study is to investigate the acute postprandial responses in uric acid, markers of oxidative stress and marker of inflammation after low fructose load with and without a high fat meal among patients with chronic kidney disease (CKD) and patients with type 2 diabetes (T2DM) with and without CKD compared to healthy controls (HC).

Patients with type 2 diabetes, patients with chronic kidney disease (CKD) and GFR <30 ml/min or dialysis, patients with type 2 diabetes and CKD and control subjects (n= 30 in each group) will be included. Participant will on sex different occasions receive drinks containing fructose with and without the addition of a high-fat meal. After including 8 patients with CKD, 8 patients with T2DM and 8 controls, the preliminary results will be presented.

Being tested
Blueberry drink, Blueberry and pizza, Soft beverage, Soft beverage and pizza, Fructose
Keywords
Fructose, Uric acid, Oxidised LDL, Interleukin 6
Medical subject headings
Renal Insufficiency, Chronic, Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Blueberry drinkOther

    Participant receive blueberry drink

  • Blueberry and pizzaOther

    Participant receive blueberry drink and a slice of pizza

  • Soft beverageOther

    Participant receive a soft beverage drink

  • Soft beverage and pizzaOther

    Participant receive a soft beverage drink and a slice of pizza

  • FructoseOther

    Participant receive a drink containing fructose

  • Fructose and pizzaOther

    Participant receive a fructose drink and a slice of pizza

Study groups in NCT03157960
Study groupRoleWhat they receive
Blueberry drinkExperimentalParticipant will receive a blueberry drink containing 18 g of fructose and 14 g of glucose.
Receives: Other: Blueberry drink
Blueberry and pizzaExperimentalParticipant will receive a blueberry drink and a slice of pizza (170 grams; 22 g protein, 20 g fat and 50 g carbohydrate; 425 kCal)
Receives: Other: Blueberry and pizza
Soft beverageExperimentalParticipant will receive a Soft beverage (Coca-cola containing 17,5 g fructose and 17,5 g glucose)
Receives: Other: Soft beverage
Soft beverage and pizzaExperimentalParticipant will receive a Soft beverage and a slice of pizza (170 grams; 22 g protein, 20 g fat and 50 g carbohydrate; 425 kCal)
Receives: Other: Soft beverage and pizza
FructoseExperimentalParticipant will receive a drink containing 35 g of fructose
Receives: Other: Fructose
Fructose and pizzaExperimentalParticipant 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)
Receives: Other: Fructose and pizza

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Changes in uric acid (µmol/L)

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

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 May 2017
  2. Study start1 Feb 2012
  3. Primary completion30 Nov 2019
  4. Study completion30 Nov 2021

Resources

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
Basic science
Allocation
Randomised
Intervention model
Crossover
Model description
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
Masking
None (open label)
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03157960
Sponsor's protocol ID
2011/1183-31/2
Status last verified
Feb 2022
First submitted
16 May 2017
Last updated
22 Feb 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 26199742
  • 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.

    PubMed 20086073
  • 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.

    PubMed 11804845
  • 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.

    PubMed 26049401
  • Mayes PA. Intermediary metabolism of fructose. Am J Clin Nutr. 1993 Nov;58(5 Suppl):754S-765S. doi: 10.1093/ajcn/58.5.754S.

    PubMed 8213607
  • 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.

    PubMed 24760443
  • 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.

    PubMed 18946066
  • 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.

    PubMed 21195935
  • 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.

    PubMed 21547469
  • 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.

    PubMed 23588856
  • 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.

    PubMed 19896746
  • 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.

    PubMed 20171754
  • 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.

    PubMed 15089783
  • 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.

    PubMed 21151200
  • Shields J, Maxwell AP. Managing diabetic nephropathy. Clin Med (Lond). 2010 Oct;10(5):500-4. doi: 10.7861/clinmedicine.10-5-500.

    PubMed 21117388

Questions about this trial

What is this clinical trial studying?

A study testing Blueberry drink, Blueberry and pizza and Soft beverage in people with Chronic Kidney Diseases and Diabetes Mellitus, Type 2, run by Karolinska University Hospital at 1 site in Sweden.

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 3 inclusion and 5 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 22 Feb 2022. 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 Sweden. 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?

Changes in uric acid (µmol/L) (time frame: 2 hours for only drink and 4 hours for drink and a high fat meal). 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 NCT03157960, which also lists 21 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 22 Feb 2022.

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