Alimentation and Diabetes in Lanzarote - ADILAN: a Pilot Trial (ADILAN)

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

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.

Study Overview

• Status: Completed
• Conditions: Type 2 Diabetes
• Intervention / Treatment: Behavioral: Healthy diet A; Behavioral: Healthy diet B

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.

• Study Type: Interventional
• Enrollment (Actual): 14
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Las Palmas
    • Arrecife, Las Palmas, Spain, 35500
      • Hospital Insular de Lanzarote

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Diet A; Healthy diet with grains and dairy	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.
ACTIVE_COMPARATOR: Diet B; Healthy diet without grains and dairy	Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Fasting fructosamine	Laboratory tests will be performed at baseline and after 4, 10 and 14 weeks
Fasting glucagon	Laboratory tests will be performed at baseline and after 4, 10 and 14 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
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
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
Fasting plasma glucose	Laboratory tests will be performed at baseline and after 4, 10 and 14 weeks
Total cholesterol	Laboratory tests will be performed at baseline and after 4, 10 and 14 weeks
Low-density lipoprotein (LDL) cholesterol	Laboratory tests will be performed at baseline and after 4, 10 and 14 weeks
High-density lipoprotein (HDL) cholesterol	Laboratory tests will be performed at baseline and after 4, 10 and 14 weeks
Triglycerides	Laboratory tests will be performed at baseline and after 4, 10 and 14 weeks
Systolic and diastolic blood pressure	To be assessed at baseline and after 4, 10 and 14 weeks
High-sensitive C-reactive protein	Laboratory tests will be performed at baseline and after 4, 10 and 14 weeks
Waist circumference	To be assessed at baseline and after 4, 10 and 14 weeks
Hip circumference	To be assessed at baseline and after 4, 10 and 14 weeks
Sagittal abdominal diameter	To be assessed at baseline and after 4, 10 and 14 weeks
Tricipital, bicipital, suprailiac and subscapular skinfold thickness	To be assessed at baseline and after 4, 10 and 14 weeks
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
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
Change in medication	To be assessed at baseline and after 4, 10 and 14 weeks
Body weight	To be assessed at baseline and after 4, 10 and 14 weeks
Fasting HbA1c	Laboratory tests will be performed at baseline and after 4, 10 and 14 weeks

Collaborators and Investigators

• Sponsor: Lund University
• Collaborators: Cabildo de Lanzarote; Ayuntamiento de Teguise; Ayuntamiento de Arrecife

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: November 1, 2013
• Primary Completion (ACTUAL): February 1, 2014
• Study Completion (ACTUAL): February 1, 2014

Study Registration Dates

• First Submitted: June 28, 2013
• First Submitted That Met QC Criteria: July 2, 2013
• First Posted (ESTIMATE): July 3, 2013

Study Record Updates

• Last Update Posted (ESTIMATE): March 21, 2014
• Last Update Submitted That Met QC Criteria: March 20, 2014
• Last Verified: March 1, 2014

More Information

Terms related to this study

• Keywords: Metabolic syndrome; Dairy; Satiety; Dietary fiber; Food; Diabetes mellitus type 2; Cereals; Dietary carbohydrates
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: MFV-ADI-2013-01