Condition category
Nutritional, Metabolic, Endocrine
Date applied
04/11/2016
Date assigned
15/11/2016
Last edited
09/08/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

Trial website

Contact information

Type

Scientific

Primary contact

Dr Santiago Dominguez Coello

ORCID ID

http://orcid.org/0000-0003-1974-1936

Contact details

Gerencia de Atención Primaria de Tenerife
Servicio Canario de Salud.
Calle Carmen Monteverde nº 45
Santa Cruz de Tenerife
38003
Spain
+34 (0)922 581 900
sdomcoe@gobiernodecanarias.org

Type

Scientific

Additional contact

Dr Jesus Gobierno Hernandez

ORCID ID

Contact details

Consultorio el Escobonal
Plaza San Jose S/N
El Escohonal-Güimar
38591
Spain
+34 (0)822 171 816
jgobierno@gmail.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

ISCIII 012/00231 and OBE04/2013

Study information

Scientific title

Effect of a diet low in fructose and sucrose on insulin resistance: clinical trial in primary care

Acronym

DISFRUTE

Study hypothesis

A low fructose/sucrose diet reduces insulin resistance more than a standard diet.

Ethics approval

CEIC Hospital Universitario Nuestra Señora de Candelaria-Tenerife-Canary Islands Spain, 23/05/2012, ref: 160

Study design

Single-blind multi-centre randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

GP practices

Trial type

Prevention

Patient information sheet

Not available in web format, please use the contact details to request a patient information sheet

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

Phase

Drug names

Primary outcome measures

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 trial start date

31/05/2012

Overall trial end date

31/12/2017

Reason abandoned

Eligibility

Participant inclusion criteria

1. Age between 29-66 years
2. BMI between 29 and 40.99 kg/m2

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

245 in each group

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

Trial participating centre

Centro de Salud (CS) de La Victoria de Acentejo
C/Domingo Salazar 21
La Victoria de Acentejo
38380
Spain

Trial participating centre

CS La Matanza de Acentejo
Carretera General del Norte Ermita
La Matanza de Acentejo
38370
Spain

Trial participating centre

CS Santa Úrsula
C/Calvo Sotelo s/n
Santa Ursula
38390
Spain

Trial participating centre

Consultorio La Perdoma
C/ Manuel Vega Santos, nº 7
La Orotava
38315
Spain

Trial participating centre

CS Los Realejos
C/San Isidro nº 10
Los Realejos
38410
Spain

Trial participating centre

CS Casco Botánico
Carretera Las Dehesas nº 8
Puerto de La Cruz
38400
Spain

Trial participating centre

CS Tacoronte
Carretera General del Norte nº 5
Tacoronte
38350
Spain

Trial participating centre

Consultorio La Esperanza
Carretera Sardinera s/n
La Laguna
38290
Spain

Trial participating centre

Consultorio Valle Guerra
C/Camino Las Toscas nº 4
La Laguna
38290
Spain

Trial participating centre

CS Taco
C/Moisés Alberto s/n
Santa Cruz de Tenerife
38108
Spain

Trial participating centre

CS Guimar
C/Poeta Hernández Mora s/n
Güimar
38500
Spain

Trial participating centre

CS Barranco Grande
Calle Ruiseñor, s/n
Santa Cruz de Tenerife
38107
Spain

Trial participating centre

CS Ofra Delicias
Avenida Príncipes de España 7A
Santa Cruz de Tenerife
38310
Spain

Trial participating centre

CS Toscal-Centro
C/Ruiz de Padrón 6
Santa Cruz de Tenerife
38002
Spain

Trial participating centre

CS Finca España
Carretera General Santa Cruz-Laguna nº 141
La Laguna
38201
Spain

Trial participating centre

Consultorio Igueste de Candelaria
C/ Ajoreña 0
Candelaria
38520
Spain

Sponsor information

Organisation

Fundación Canaria de Investigación Sanitaria

Sponsor details

Barranco La Ballena s/n
CIF: G76208396
La Palmas de Gran Canaria
35019
Spain
+34 (0)922 679 123
aparache@funcanis.org

Sponsor type

Research organisation

Website

www.funcanis.org

Funders

Funder type

Government

Funder name

Instituto de Salud Carlos III

Alternative name(s)

Institute of Health Carlos III, Carlos III Health Institute, ISCIII

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

Spain

Funder name

Fundacion Caja Canarias

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

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 2018.

Intention to publish date

31/12/2018

Participant level data

To be made available at a later date

Results - basic reporting

Publication summary

2017 protocol in: https://www.ncbi.nlm.nih.gov/pubmed/28784181

Publication citations

Additional files

Editorial Notes

09/08/2017: Publication reference added.