Clinical trial NCT01891955: Alimentation and Diabetes in Lanzarote - ADILAN: a Pilot Trial
Official title: Alimentation and Diabetes in Lanzarote - ADILAN: a Randomized Cross-over Pilot Trial Comparing a Healthy Diet With Grains and Dairy to a Healthy Diet Without Grains and Dairy in Patients With Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes
Keywords: Diabetes mellitus type 2
Cereals
Dairy
Dietary carbohydrates
Dietary fiber
Food
Metabolic syndrome
Satiety
Lead sponsor: Lund University
Sponsor class: OTHER
Collaborators: name: Cabildo de Lanzarote
name: Ayuntamiento de Teguise
name: Ayuntamiento de Arrecife
First posted: 2013-07-03
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare two healthy diets (according to official Spanish guidelines) that have been shown to be effective in the treatment of type 2 diabetes in order to see if one is better than the other.

Another goal is to test the hypothesis that food choice has metabolic effects that are independent of macro/micronutrient composition, fiber content, glycemic load and weight loss in the treatment of type 2 diabetes.

Detailed description: There is some uncertainty with respect to the optimal dietary treatment of type 2 diabetes. In addition to energy balance, macronutrient composition, dietary fiber and glycemic load, increasing evidence suggests that the direct endocrine effects of food may be important.

In this trial, the intervention is based on two diets. The healthy diet with grains and dairy is based on whole grains, low-fat dairy, fish, shellfish, fruit, vegetables, legumes, eggs, nuts and refined vegetable oils rich in monounsaturated fatty acids (this is called "healthy diet A"). The healthy diet without grains and dairy is based on fish, shellfish, lean meat, fruit, vegetables, root vegetables, eggs and nuts, but excludes grains, legumes, refined vegetable oils, dairy products and salt (this is called "healthy diet B"). Both diets were classified as very healthy using validated nutritional software, and are considered healthy regarding macronutrient composition, fiber, mineral and vitamin intake according to the official Spanish dietary guidelines. The macro and micronutrient ratios, fiber content and glycemic load in healthy diet A and healthy diet B have been set to be equal.

The goal is to include 15 patients (\>18 years) with medical diagnosis of type 2 diabetes, with or without medication, and increased waist circumference (≥80 cm for women and ≥94 cm for men), to a cross-over trial during two periods of 4-weeks separated by a 6-week washout period.

Lunch will be served in a hospital kitchen for control of nutrient intake, while the rest of meals will be eaten at home according to specific directions.

The working hypothesis of this study is that food choice has beneficial effects on the control of glucose beyond macro/micronutrient composition, fiber content, glycemic load and weight loss.

This study will provide information on whether food choice and diet quality has greater impact than macro/micronutrient composition, fiber content, glycemic load and weight loss in glucose control in patients with type 2 diabetes, and the need to conduct a long-term trial testing our hypothesis.

Eligibility criteria: Inclusion Criteria:

* Medical diagnosis of type 2 diabetes
* Increased waist circumference (≥80 cm for women and ≥94 cm for men)
* Unaltered medical diabetes treatment since three months before start of study
* Stable weight (varied less than 5%) since three months before start of study
* HbA1c ≥6.0%

Exclusion Criteria:

* Creatinine \>130 μmol/L
* Change of treatment with betablocker last 3 months
* Change of treatment with thyroid hormone substitution last 3 months
* Treatment with anticoagulant medication
* Oral or injected steroid treatment
* Elevated liver enzymes (AST, ALT, ALP, GPT \> 4 times their respective upper reference value)
* Physical or psychical illness, or changes in personal circumstances that make it impossible for the patient to continue in the study

Primary outcomes:
measure: Fasting fructosamine
timeFrame: Laboratory tests will be performed at baseline and after 4, 10 and 14 weeks
measure: Fasting glucagon
timeFrame: Laboratory tests will be performed at baseline and after 4, 10 and 14 weeks
Secondary outcomes:
measure: Area under the curve for glucose (AUC glucose0-120) at the oral glucose tolerance test
timeFrame: Laboratory tests will be performed at baseline and after 4, 10 and 14 weeks
measure: Area under the curve for glucagon (AUC glucagon0-120) at the oral glucose tolerance test
timeFrame: Laboratory tests will be performed at baseline and after 4, 10 and 14 weeks
measure: Fasting plasma glucose
timeFrame: Laboratory tests will be performed at baseline and after 4, 10 and 14 weeks
measure: Total cholesterol
timeFrame: Laboratory tests will be performed at baseline and after 4, 10 and 14 weeks
measure: Low-density lipoprotein (LDL) cholesterol
timeFrame: Laboratory tests will be performed at baseline and after 4, 10 and 14 weeks
measure: High-density lipoprotein (HDL) cholesterol
timeFrame: Laboratory tests will be performed at baseline and after 4, 10 and 14 weeks
measure: Triglycerides
timeFrame: Laboratory tests will be performed at baseline and after 4, 10 and 14 weeks
measure: Systolic and diastolic blood pressure
timeFrame: To be assessed at baseline and after 4, 10 and 14 weeks
measure: High-sensitive C-reactive protein
timeFrame: Laboratory tests will be performed at baseline and after 4, 10 and 14 weeks
measure: Waist circumference
timeFrame: To be assessed at baseline and after 4, 10 and 14 weeks
measure: Hip circumference
timeFrame: To be assessed at baseline and after 4, 10 and 14 weeks
measure: Sagittal abdominal diameter
timeFrame: To be assessed at baseline and after 4, 10 and 14 weeks
measure: Tricipital, bicipital, suprailiac and subscapular skinfold thickness
timeFrame: To be assessed at baseline and after 4, 10 and 14 weeks
measure: Satiation measured on a likert scale at food intake during 4 consecutive days
timeFrame: To be assessed at baseline and after 4, 10 and 14 weeks
measure: Quality of life using a validated spanish version of the SF-36 questionnaire
timeFrame: To be assessed at baseline and after 4, 10 and 14 weeks
measure: Change in medication
timeFrame: To be assessed at baseline and after 4, 10 and 14 weeks
measure: Body weight
timeFrame: To be assessed at baseline and after 4, 10 and 14 weeks
measure: Fasting HbA1c
timeFrame: Laboratory tests will be performed at baseline and after 4, 10 and 14 weeks
Other outcomes:
Locations:
city: Arrecife
country: Spain
facility: Hospital Insular de Lanzarote
state: Las Palmas
Study officials:
References:
citation: Nield L, Moore HJ, Hooper L, Cruickshank JK, Vyas A, Whittaker V, Summerbell CD. Dietary advice for treatment of type 2 diabetes mellitus in adults. Cochrane Database Syst Rev. 2007 Jul 18;2007(3):CD004097. doi: 10.1002/14651858.CD004097.pub4.
citation: Ajala O, English P, Pinkney J. Systematic review and meta-analysis of different dietary approaches to the management of type 2 diabetes. Am J Clin Nutr. 2013 Mar;97(3):505-16. doi: 10.3945/ajcn.112.042457. Epub 2013 Jan 30.
citation: Jonsson T, Granfeldt Y, Ahren B, Branell UC, Palsson G, Hansson A, Soderstrom M, Lindeberg S. Beneficial effects of a Paleolithic diet on cardiovascular risk factors in type 2 diabetes: a randomized cross-over pilot study. Cardiovasc Diabetol. 2009 Jul 16;8:35. doi: 10.1186/1475-2840-8-35.
citation: Lindeberg S, Jonsson T, Granfeldt Y, Borgstrand E, Soffman J, Sjostrom K, Ahren B. A Palaeolithic diet improves glucose tolerance more than a Mediterranean-like diet in individuals with ischaemic heart disease. Diabetologia. 2007 Sep;50(9):1795-1807. doi: 10.1007/s00125-007-0716-y. Epub 2007 Jun 22.
citation: Jonsson T, Olsson S, Ahren B, Bog-Hansen TC, Dole A, Lindeberg S. Agrarian diet and diseases of affluence--do evolutionary novel dietary lectins cause leptin resistance? BMC Endocr Disord. 2005 Dec 10;5:10. doi: 10.1186/1472-6823-5-10.
citation: Fontes-Villalba M, Jonsson T, Granfeldt Y, Frassetto LA, Sundquist J, Sundquist K, Carrera-Bastos P, Fika-Hernando M, Picazo O, Lindeberg S. A healthy diet with and without cereal grains and dairy products in patients with type 2 diabetes: study protocol for a random-order cross-over pilot study--Alimentation and Diabetes in Lanzarote--ADILAN. Trials. 2014 Jan 2;15:2. doi: 10.1186/1745-6215-15-2.