Alimentation and Diabetes in Lanzarote - ADILAN: a Pilot Trial

Type 2 Diabetes Clinical Trial

— ADILAN  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01891955
• Other study ID #: MFV-ADI-2013-01
• Status: Completed
• Phase: N/A
• First received: June 28, 2013
• Last updated: March 20, 2014
• Start date: November 2013
• Est. completion date: February 2014

Study information

• Verified date: March 2014
• Source: Lund University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Comité Ético de Investigación ClínicaSpain: Agencia Española de Medicamentos y Productos Sanitarios
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: February 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

Behavioral:
• Healthy diet A
Healthy diet A will include fruit, vegetables, fish, shellfish, lean meat, nuts, eggs and olive oil. Macro/micronutrient composition, fiber intake and glycemic load will not differ from healthy diet B. Healthy diet A will include substantial amounts of whole grains, low-fat dairy and legumes (this is called "healthy diet with grains and dairy"). This diet is classified as very healthy using validated nutritional software. It is in accordance with official Spanish dietary recommendations for people with diabetes type 2 regarding macronutrient composition, dietary fiber, minerals and vitamins.
• Healthy diet B
Healthy diet B will include fruit, vegetables, fish, shellfish, lean meat, nuts, eggs and olive oil. Macro/micronutrient composition, fiber intake and glycemic load will not differ from healthy diet A. Healthy diet B will exclude grains, legumes and dairy, which will largely be replaced by root vegetables, vegetables and fruit, and slightly more lean meat, fish and nuts (this is called "healthy diet without grains and dairy"). Salt intake will be lower in healthy diet B. This diet is classified as very healthy using validated nutritional software. It is in accordance with official Spanish dietary recommendations for people with diabetes type 2 regarding macronutrient composition, dietary fiber, minerals and vitamins.

Locations

Country	Name	City	State
Spain	Hospital Insular de Lanzarote	Arrecife	Las Palmas

Sponsors (4)

Lead Sponsor	Collaborator
Lund University	Ayuntamiento de Arrecife, Ayuntamiento de Teguise, Cabildo de Lanzarote

Country where clinical trial is conducted

Spain, 

References & Publications (5)

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. Review. — View Citation

Jönsson T, Granfeldt Y, Ahrén B, Branell UC, Pålsson G, Hansson A, Söderström 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. — View Citation

Jönsson T, Olsson S, Ahrén B, Bøg-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. — View Citation

Lindeberg S, Jönsson T, Granfeldt Y, Borgstrand E, Soffman J, Sjöström K, Ahrén B. A Palaeolithic diet improves glucose tolerance more than a Mediterranean-like diet in individuals with ischaemic heart disease. Diabetologia. 2007 Sep;50(9):1795-807. Epub 2007 Jun 22. — View 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;(3):CD004097. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fasting fructosamine		Laboratory tests will be performed at baseline and after 4, 10 and 14 weeks	No
Primary	Fasting glucagon		Laboratory tests will be performed at baseline and after 4, 10 and 14 weeks	No
Secondary	Area under the curve for glucose (AUC glucose0-120) at the oral glucose tolerance test		Laboratory tests will be performed at baseline and after 4, 10 and 14 weeks	No
Secondary	Area under the curve for glucagon (AUC glucagon0-120) at the oral glucose tolerance test		Laboratory tests will be performed at baseline and after 4, 10 and 14 weeks	No
Secondary	Fasting plasma glucose		Laboratory tests will be performed at baseline and after 4, 10 and 14 weeks	No
Secondary	Total cholesterol		Laboratory tests will be performed at baseline and after 4, 10 and 14 weeks	No
Secondary	Low-density lipoprotein (LDL) cholesterol		Laboratory tests will be performed at baseline and after 4, 10 and 14 weeks	No
Secondary	High-density lipoprotein (HDL) cholesterol		Laboratory tests will be performed at baseline and after 4, 10 and 14 weeks	No
Secondary	Triglycerides		Laboratory tests will be performed at baseline and after 4, 10 and 14 weeks	No
Secondary	Systolic and diastolic blood pressure		To be assessed at baseline and after 4, 10 and 14 weeks	No
Secondary	High-sensitive C-reactive protein		Laboratory tests will be performed at baseline and after 4, 10 and 14 weeks	No
Secondary	Waist circumference		To be assessed at baseline and after 4, 10 and 14 weeks	No
Secondary	Hip circumference		To be assessed at baseline and after 4, 10 and 14 weeks	No
Secondary	Sagittal abdominal diameter		To be assessed at baseline and after 4, 10 and 14 weeks	No
Secondary	Tricipital, bicipital, suprailiac and subscapular skinfold thickness		To be assessed at baseline and after 4, 10 and 14 weeks	No
Secondary	Satiation measured on a likert scale at food intake during 4 consecutive days		To be assessed at baseline and after 4, 10 and 14 weeks	No
Secondary	Quality of life using a validated spanish version of the SF-36 questionnaire		To be assessed at baseline and after 4, 10 and 14 weeks	No
Secondary	Change in medication		To be assessed at baseline and after 4, 10 and 14 weeks	No
Secondary	Body weight		To be assessed at baseline and after 4, 10 and 14 weeks	No
Secondary	Fasting HbA1c		Laboratory tests will be performed at baseline and after 4, 10 and 14 weeks