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| Name | Class |
|---|---|
| Cabildo de Lanzarote | UNKNOWN |
| Ayuntamiento de Teguise | UNKNOWN |
| Ayuntamiento de Arrecife | UNKNOWN |
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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Diet A | Active Comparator | Healthy diet with grains and dairy |
|
| Diet B | Active Comparator | Healthy diet without grains and dairy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Healthy diet A | Behavioral | 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. |
| Measure | Description | 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 |
| Measure | Description | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Insular de Lanzarote | Arrecife | Las Palmas | 35500 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17636747 | Background | 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. | |
| 23364002 | Background | 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. |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D024821 | Metabolic Syndrome |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| Healthy diet B | Behavioral | 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. |
|
| 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 |
| 19604407 | Background | 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. |
| 17583796 | Background | 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. |
| 16336696 | Background | 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. |
| 24383431 | Derived | 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. |
| D004700 | Endocrine System Diseases |
| D007333 | Insulin Resistance |
| D006946 | Hyperinsulinism |