Relationship between a low fructose consumption and insulin resistance
| ISRCTN | ISRCTN41579277 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN41579277 |
| Secondary identifying numbers | ISCIII 012/00231 and OBE04/2013 |
- Submission date
- 04/11/2016
- Registration date
- 15/11/2016
- Last edited
- 06/05/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Plain English Summary
Background and study aims
Insulin resistance (IR) is a condition in which the cells of the body do not respond normally to the hormone insulin, leading to high blood sugar levels. IR is a strong predictor for the development of type 2 diabetes mellitus and cardiovascular disease (heart and blood vessel disease). Fructose (a natural sugar found in plants) has become a widely-used additive in many food industry products such as soft drinks and nonalcoholic beverages, generally in the form of fructose-enriched corn syrup. The aim of this study is to determine whether a low fructose diet supervised by a physician or nurse decreases IR compared to a standard diet.
Who can participate?
Overweight and obese adults aged between 29 and 66.
What does the study involve?
Health care zones are randomly allocated to one of two groups. Those in the first group are asked to follow a low fructose diet. Those in the second group are advised to eat a standard diet. The calories in diets in both groups contain around 30-40% less than each individual’s calorie requirements to help them to lose weight. Participants in both groups provide blood samples at the start of the study and then again after 24 and 48 weeks to assess insulin resistance. In addition, the cholesterol and fat levels in the blood and their BMI are measured at the same timepoints.
What are the possible benefits and risks of participating?
There are no direct benefits involved with participating. There is a small risk of pain, bruising or bleeding when blood samples are taken.
Where is the study run from?
Primary care centers in the island of Tenerife (Canary Islands, Spain)
When is the study starting and how long is it expected to run for?
May 2012 to December 2017
Who is funding the study?
1. Instituto de Salud Carlos III (Spain)
2. Fundacion Caja Canarias (Spain)
Who is the main contact?
Dr Santiago Domínguez-Coello
sdomcoe@gobiernodecanarias.org
Contact information
Scientific
Gerencia de Atención Primaria de Tenerife
Servicio Canario de Salud.
Calle Carmen Monteverde nº 45
Santa Cruz de Tenerife
38003
Spain
 ORCID ID |
0000-0003-1974-1936 |
|---|---|
| Phone | +34 (0)922 581 900 |
| sdomcoe@gobiernodecanarias.org |
Scientific
Consultorio el Escobonal
Plaza San Jose S/N
El Escohonal-Güimar
38591
Spain
| Phone | +34 (0)822 171 816 |
|---|---|
| jgobierno@gmail.com |
Study information
| Study design | Single-blind multi-centre randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | GP practice |
| Study type | Prevention |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | Effect of a diet low in fructose and sucrose on insulin resistance: clinical trial in primary care |
| Study acronym | DISFRUTE |
| Study hypothesis | A low fructose/sucrose diet reduces insulin resistance more than a standard diet. |
| Ethics approval(s) | CEIC Hospital Universitario Nuestra Señora de Candelaria-Tenerife-Canary Islands Spain, 23/05/2012, ref: 160 |
| Condition | Insulin resistance |
| Intervention | Participants are randomized by health care zone to one of two groups. Low-fructose diet intervention (LFDI) group: Participants are assigned to health centers in the western zone of Tenerife island. They are advised to eat a low-fructose diet (1000, 1250, 1500, 1750, 2000, 2250, 2500 or 2750 kcal/day). Low-fructose diets are designed by calculating free and total (free + fructose associated with sucrose) fructose contents in standard diets. Foods with a fructose content in the highest quartile for the amounts corresponding to the standard diet are removed from the standard diet. Standard diet control (SDC) group: Participants are assigned to health centers in the eastern zone of the island. They are advised to eat a standard diet (recommended by the Canary Health Service). The kcal/day in the prescribed diets are calculated as 30% or 40% less than the kcal/day in the participant’s energy requirements for his or her ideal weight according to age, sex and physical activity. Follow up for all participants takes place at 4, 8, 12, 20, 24 and 48 weeks, and involves nutrition counseling and reinforcement, as well as the measure of weight, waist circumference and blood pressure. |
| Intervention type | Other |
| Primary outcome measure | Insulin resistance is estimated from fasting serum glucose (measured with enzymatic methods) and insulin concentrations (measured with a chemiluminescence immunoassay method) with a computer-based Homeostasis Model Assessment system (HOMA2-IR) at baseline, 24 and 48 weeks. |
| Secondary outcome measures | 1. Body mass index is determined using weight and height measurements at baseline, 4, 8, 12, 20, 24 and 48 weeks 2. Waist circumference is determined using a nonstretchable measuring tape at baseline, 4, 8, 12, 20, 24 and 48 weeks 3. Total Cholesterol, HDL cholesterol and triglycerides are measured using enzymatic methods at baseline, 24 and 48 weeks. LDL cholesterol is calculated using the Friedewald formula |
| Overall study start date | 31/05/2012 |
| Overall study end date | 01/04/2018 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 245 in each group |
| Total final enrolment | 438 |
| Participant inclusion criteria | 1. Age between 29-66 years 2. BMI between 29 and 40.99 kg/m2 |
| Participant exclusion criteria | 1. Pregnancy (female participants only) 2. Behavioral eating disorders 3. Relevant gastrointestinal disease (ulcerating colitis, Crohn’s disease, celiac disease, digestive tract cancer) 4. Excessive alcohol consumption (>28 U or 280 g/week in men, > 17 U or 168 g/week in women 5. Severe cardiovascular disease 6. Diabetes, 7. Polycystic ovary disease 8. Treatment with any medication that could alter insulin sensitivity or body weight (corticosteroids, antipsychotics, antidepressants) 9. Pharmacological treatment for clinical or subclinical hypothyroidism 10. Hyperthyroidism 11. Depression 12. Psychosis 13. Microalbumin/creatinine ratio >100 mg/g or stage IIIB or higher chronic kidney disease (glomerular filtration rate < 45 mL/min) 14. Use of medication requiring frequent dose adjustments 15. Low intellectual or mental functioning that could interfere with the participant’s compliance with the recommendations 16. If the result of the glucose overload test is blood glucose ≥ 200 mg/dL the participant is excluded if the physician opts to add medication or insulin to the dietary and physical exercise regime. |
| Recruitment start date | 01/05/2014 |
| Recruitment end date | 30/06/2017 |
Locations
Countries of recruitment
- Spain
Study participating centres
La Victoria de Acentejo
38380
Spain
Ermita
La Matanza de Acentejo
38370
Spain
Santa Ursula
38390
Spain
La Orotava
38315
Spain
Los Realejos
38410
Spain
Puerto de La Cruz
38400
Spain
Tacoronte
38350
Spain
La Laguna
38290
Spain
La Laguna
38290
Spain
Santa Cruz de Tenerife
38108
Spain
Güimar
38500
Spain
Santa Cruz de Tenerife
38107
Spain
Santa Cruz de Tenerife
38310
Spain
Santa Cruz de Tenerife
38002
Spain
La Laguna
38201
Spain
Candelaria
38520
Spain
Sponsor information
Research organisation
Barranco La Ballena s/n
CIF: G76208396
La Palmas de Gran Canaria
35019
Spain
| Phone | +34 (0)922 679 123 |
|---|---|
| aparache@funcanis.org | |
| Website | www.funcanis.org |
"ROR" |
https://ror.org/03vhx9d88 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- SaludISCIII, InstitutodeSaludCarlosIII, Instituto de Salud Carlos III | Madrid, Spain, Carlos III Institute of Health, Institute of Health Carlos III, Carlos III Health Institute, ISCIII
- Location
- Spain
No information available
No information available
Results and Publications
| Intention to publish date | 01/04/2019 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication of the study protocol immediately once the trial is registered. This protocol details how all foods and nutrient contents were obtained. Planned submission of the results for publication during the first months of 2019. |
| IPD sharing plan | The datasets generated and analysed during the current study will be available upon request from Santiago Domínguez-Coello (sdomcoe@gobiernodecanarias.org; sdominguezc@telefonica.net) once this study has been published. These datasets will be available at any time and will be anonymous. All the requirements will have to be motivated on specific scientific reasons which must be detailed. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 07/08/2017 | Yes | No | |
| Basic results | 14/01/2018 | 14/01/2019 | No | No | |
| Basic results | 03/12/2019 | 03/12/2019 | No | No | |
| Results article | results | 19/04/2020 | 06/05/2020 | Yes | No |
Additional files
- ISRCTN41579277_BasicResults_14Jan18.pdf
- Uploaded 14/01/2019
- ISRCTN41579277_BasicResults_03Dec19.pdf
- Uploaded 03/12/2019
Editorial Notes
06/05/2020: Publication reference and total final enrolment number added.
03/12/2019: The updated basic results of this trial have been uploaded as an additional file.
21/06/2019: Internal review.
21/01/2019: IPD sharing statement added.
14/01/2019: The following changes were made to the trial record:
1. The overall trial end date was changed from 31/12/2017 to 01/04/2018.
2. Fundación DISA: premios de investigación médica 2018 was added as a funder.
3. The basic results of this trial have been uploaded as an additional file.
09/08/2017: Publication reference added.
