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.
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
- Conditions the study is for
- Chronic Kidney Diseases, Diabetes Mellitus, Type 2
- 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.
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.
- Conditions
- Chronic Kidney Diseases, Diabetes Mellitus, Type 2
- 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 group | Role | What they receive |
|---|---|---|
| Blueberry drink | Experimental | Participant will receive a blueberry drink containing 18 g of fructose and 14 g of glucose. Receives: 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) Receives: 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) Receives: 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) Receives: Other: Soft beverage and pizza |
| Fructose | Experimental | Participant will receive a drink containing 35 g of fructose Receives: 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) Receives: Other: Fructose and pizza |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
- First posted17 May 2017
- Study start1 Feb 2012
- Primary completion30 Nov 2019
- Study completion30 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (21)Papers the sponsor has linked to this study.
- Other trials for Chronic Kidney DiseasesStudies of the same condition, open and under way.
- More trials run by Karolinska University HospitalThe sponsor's other registered studies.
- 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
- 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)
Sponsor and investigators
- Lead sponsor
- Karolinska University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Neda Rajamand Ekberg, Karolinska University Hospital
- Investigators
- Peter Stenvinkel, professor, Study director, Karolinska University Hospital
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 26199742Tappy 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 20086073Dyer 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 11804845Bjornstad 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 26049401Mayes PA. Intermediary metabolism of fructose. Am J Clin Nutr. 1993 Nov;58(5 Suppl):754S-765S. doi: 10.1093/ajcn/58.5.754S.
PubMed 8213607Jia 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 24760443Feig 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 18946066Hovind 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 21195935Riegersperger 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 21547469Soltani 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 23588856Shaw 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 19896746Zhang 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 20171754Davies 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 15089783Singh 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 21151200Shields J, Maxwell AP. Managing diabetic nephropathy. Clin Med (Lond). 2010 Oct;10(5):500-4. doi: 10.7861/clinmedicine.10-5-500.
PubMed 21117388
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Acute Fructose Load in Patients With Chronic Kidney Disease and Patients With Type 2 Diabetes Compared to Healthy Subjects
- ClinicalTrials.gov ID
- NCT03157960
- Acronym / sponsor ID
- 2011/1183-31/2
- Conditions
- Chronic Kidney Diseases, Diabetes Mellitus, Type 2
- Keywords
- Fructose, Uric acid, Oxidised LDL, Interleukin 6
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Karolinska University HospitalUniversity, hospital or other
- Study start
- 1 Feb 2012 (actual)
- Primary completion
- 30 Nov 2019 (actual)
- Study completion
- 30 Nov 2021 (actual)
- First posted
- 17 May 2017 (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 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.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 6
- 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
| Arm | Type | Receives |
|---|---|---|
| Blueberry drink | Experimental | Other: Blueberry drinkParticipant will receive a blueberry drink containing 18 g of fructose and 14 g of glucose. |
| Blueberry and pizza | Experimental | Other: Blueberry and pizzaParticipant will receive a blueberry drink and a slice of pizza (170 grams; 22 g protein, 20 g fat and 50 g carbohydrate; 425 kCal) |
| Soft beverage | Experimental | Other: Soft beverageParticipant will receive a Soft beverage (Coca-cola containing 17,5 g fructose and 17,5 g glucose) |
| Soft beverage and pizza | Experimental | Other: Soft beverage and pizzaParticipant will receive a Soft beverage and a slice of pizza (170 grams; 22 g protein, 20 g fat and 50 g carbohydrate; 425 kCal) |
| Fructose | Experimental | Other: FructoseParticipant will receive a drink containing 35 g of fructose |
| Fructose and pizza | Experimental | Other: Fructose and pizzaParticipant 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) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
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 |
|---|---|---|
| Blueberry drinkParticipant receive blueberry drink | Other | Blueberry drink |
| Blueberry and pizzaParticipant receive blueberry drink and a slice of pizza | Other | Blueberry and pizza |
| Soft beverageParticipant receive a soft beverage drink | Other | Soft beverage |
| Soft beverage and pizzaParticipant receive a soft beverage drink and a slice of pizza | Other | Soft beverage and pizza |
| FructoseParticipant receive a drink containing fructose | Other | Fructose |
| Fructose and pizzaParticipant receive a fructose drink and a slice of pizza | Other | Fructose and pizza |
Primary outcome
Changes in uric acid (µmol/L)
Time frame: 2 hours for only drink and 4 hours for drink and a high fat meal
Change in uric acid after intervention compared to the levels Before the intervention
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 22 Feb 2022.
- Background: PubMed 26199742Kolderup 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.
- Background: PubMed 20086073Tappy 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.
- Background: PubMed 11804845Dyer 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.
- Background: PubMed 26049401Bjornstad 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.
- Background: PubMed 8213607Mayes PA. Intermediary metabolism of fructose. Am J Clin Nutr. 1993 Nov;58(5 Suppl):754S-765S. doi: 10.1093/ajcn/58.5.754S.
- Background: PubMed 24760443Jia 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.
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- 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.
Peter Stenvinkel, professor study director
Karolinska University Hospital
1 site in 1 country: see every site and its status.
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.