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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

  • 1, 6Email author,
  • 1,
  • 2,
  • 3,
  • 1,
  • 1,
  • 1,
  • 4,
  • 5 and
  • 1
Trials201415:2

https://doi.org/10.1186/1745-6215-15-2

  • Received: 22 October 2013
  • Accepted: 16 December 2013
  • Published:
Open Peer Review reports

Abstract

Background

Research on the role of nutrition in type 2 diabetes has largely focused on macro/micronutrient composition and dietary fiber intake, while fewer studies have tested the effects of differing food choice. Some observational studies and short-term intervention studies suggest that a food pattern mimicking the diet with which humans evolved positively influences glucose control and associated endocrine systems. Such a food pattern mainly differs from other common healthy food patterns in its absence of cereal grains and dairy products. The primary aim of this pilot study is to determine the effect of two healthy diets with or without cereal grains and dairy products on glucose control, while keeping participants’ weight stable and other food parameters, such as macro/micronutrient composition, dietary fiber and glycemic load, the same in both diets.

Methods/Design

We intend to include 15 adult patients with a medical diagnosis of type 2 diabetes mellitus with or without medication and with an increased waist circumference (≥ 80 cm for women and ≥ 94 cm for men) in a random-order cross-over diet intervention study during two periods of four-weeks separated by a six-week washout period. Patients will be instructed to eat two healthy diets according to official dietary guidelines with respect to macro/micronutrient composition and fiber content, but differing in the type of food included, with one diet being without cereal grains and dairy products. Lunch will be served in a hospital kitchen for control of nutrient intake, while the rest of the meals will be eaten at home according to specific directions. The energy content of the diets will be individually adjusted to maintain a stable body weight during the two four-week intervention periods. Primary outcomes will be change in fasting plasma glucagon and fructosamine, while secondary outcomes include change in fasting glucose and glycated hemoglobin, glucose and glucagon response during oral glucose tolerance test, blood lipids, blood pressure, C-reactive protein, body composition, quality of life, subjective experience with the two diets, satiety scores and changes in medication.

Discussion

Using these results, we will assess the need to conduct larger and longer studies with similar design.

Trial registration

This trial was registered at clinicaltrials.gov as NCT01891955 and Spanish Agency of Medication and Sanitary Products (AEMPS) registration code: MFV-ADI-2013-01.

Keywords

  • Protocol
  • Random-order cross-over trial
  • Type 2 diabetes mellitus
  • Metabolic diseases
  • Dietary intervention
  • Grain-free diet
  • Dairy-free diet
  • Glucagon
  • Fructosamine

Background

The prevalence of type 2 diabetes mellitus (T2DM) has increased dramatically (more than doubled) since 1980, with a global prevalence of 9.8% and 9.25% for men and women, respectively, and affecting 347 million adults in 2008 [1]. In Europe, the prevalence of T2DM is estimated to be 8.1% of the adult population, affecting 52.8 million people in 2011. The estimated prevalence of T2DM for 2030 is 9.5% of the adult population affecting 64.2 million people. T2DM accounts for 85 to 90% of all cases of diabetes mellitus.

T2DM is one of the world’s most important causes of mortality, disability and economic cost due to the associated increase in the risk of micro- [2] and macrovascular [3] complications. T2DM caused 282,400 and 317,000 deaths in 2011, for men and women, respectively [4]. Estimates indicate that at least USD 131 million were spent in Europe due to T2DM in 2011 [4]. In 2003, the prevalence of T2DM in the archipelago of Canary Islands (Spain) was estimated to be 12% of the population with an economic cost of €38.8 million, which accounts for 2.1% of all the health costs of the Canary Islands’ Government [5, 6]. Furthermore, micro- and macrovascular complications, including end-stage renal disease, are four to five times higher than in the rest of Spain [6, 7]. In impaired glucose tolerance (IGT), lifestyle intervention reduces the incidence of T2DM [8], even when compared with insulin sensitizing medication [9]. In a study from primary health care in Stockholm, more cardiovascular risk factors were improved after an exercise intervention in people with normal glucose tolerance compared with those with IGT or T2DM [10]. However, in these studies the separate effect of exercise versus diet could not be elucidated [11]. Data from systematic reviews regarding the role of food in the prevention and treatment of T2DM indicates that there are some uncertainties with respect to the optimal dietary intervention [11, 12], and results from one large interventional dietary study suggest that targeting macronutrient composition by lowering total fat intake and increasing carbohydrate intake from whole grains, may have detrimental effects in women with pre-existing T2DM [13]. A recent intensive diet and exercise program in patients with T2DM was stopped because the intervention did not reduce cardiovascular risk, despite significant weight loss at four years, compared to the control group [14]. Research on the role of nutrition in T2DM has largely focused on macro/micronutrient composition and fiber intake, while fewer studies have tested the more direct endocrine effects of food [13, 15, 16]. A recent systematic review and meta-analysis suggests that low-carbohydrate, low-glycemic index, Mediterranean and high-protein diets may be effective in improving cardiovascular disease risk and diabetes management compared to control diets, with no significant difference effect between the different interventions [17]. Also, the effect of weight loss over macronutrient composition precludes drawing a definitive conclusion derived from this meta-analysis.

Theoretically, dietary interventions can improve glucagon [18] and leptin physiology [19]. Thus, we speculate that the possible effects of the diets in the ADILAN study could be mediated, in part, by improving the action of those hormones.

Some observational studies [20] and two short-term intervention trials from our group [21, 22] suggest that a food pattern mimicking the diet with which humans evolved, may be an optimal approach for patients with T2DM. Importantly, the short-term trials compared the experimental approach to the recommended dietary treatment in each case, namely the Mediterranean diet for patients with ischemic heart disease [21] and the American Diabetes Association diet for patients with T2DM [22], respectively. In both trials, the experimental approach resulted in better outcomes than in the control diet. A noteworthy finding in those dietary trials is the significant difference in reported macronutrient composition between interventions and controls, specifically, higher energy percentage intake for protein and fat (except in Lindeberg et al. [21] for fat), and lower energy percentage intake for carbohydrate in the experimental versus the control diet, taking into account that the intervention diet was not fixed to any dietary macronutrient ratio. Dietary glycemic load (GL) was also significantly lower.

Notwithstanding these findings, the beneficial effects shown in the experimental diets in both trials are not fully explained by macronutrient composition or GL after further statistical analysis [21, 22]. We concluded that food choice, rather than micro-and macronutrient composition, may have been the most important factor leading to the beneficial effects observed. In a recent meta-analysis comparing Mediterranean diets to alternative dietary strategies, the authors stated that the paleolithic diet (a healthy diet without grains and dairy) in the study by Lindeberg et al. [21] demonstrated the most positive effect on fasting blood glucose of all the studies included in the meta-analysis [23].

The Alimentation and Diabetes in Lanzarote (ADILAN) study

The major aim of the ADILAN study is to test the direct endocrine effect of food items beyond macro/micronutrient composition, fiber content and glycemic load of the diet. For this purpose, we will try to avoid weight loss in an attempt to isolate the effect of food, as weight loss could have been a confounding factor in the previous studies. Our objective is to run a pilot intervention for a later long-term study with a representative sample in patients with T2DM. The working hypothesis is that food choice rather than macro/micronutrient composition, fiber intake, or GL, is a major determinant for the prevention and treatment of T2DM. Hypothetically, the foods that composed the diet during most of the time of Homo sapiens’ evolution, may be the optimal dietary approach for the prevention and treatment of T2DM [24, 25].

Methods/Design

Participants

We aim to enroll 15 participants with T2DM, males and females, > 18 years old based, on the power calculations (see below) estimation of a required minimum of 13 patients, allowing for one or two drop-outs. Patients live in the island of Lanzarote, in the archipelago of Canary Islands (Spain), located off the western coast of Africa.

Recruitment

Patients will be recruited through different strategies. We are in collaboration with the Asociación de Diabéticos de Lanzarote (ADILA), a local organization, whose aim is helping patients to deal with the consequences of type 1 diabetes and T2DM. Data from 1996 estimated the prevalence of T2DM in Lanzarote to be 6.6% of the population aged between 15 and 75 years old, with an absolute number of 4,067 patients [26, 27]. ADILA will contact the potential participants registered in their database by telephone, Email and advertisement in the association’s bulletin board. In addition, we will advertise the study in the local newspapers, radio and in some institutional websites on the island of Lanzarote. Patients interested in participating in the study will receive general oral and/or written information about the study. They will be informed that our objective is to compare two healthy diets because we do not know which, if any, is the better one. If a person is interested, we will register their name and telephone number for further contact. After recruiting 15 potential participants, a meeting will be arranged to provide further details about the study.

Eligibility

We will include adults (> 18 years old), males and females, with a medical diagnosis of T2DM and increased waist circumference (≥ 80 cm for women and ≥ 94 cm for men), with or without medication (including insulin treatment), with stable weight for three months prior to the start of study, who have received no change in dose of beta blocker or thyroxine for three months prior to the start of study, and no anticoagulant or oral steroid treatment. Inclusion criteria are present glycated hemoglobin (A1c) ≥ 6.0% (≥ 42.1 mmol/mol), with no upper boundary, creatinine < 130 μmol/L and liver enzymes less than four times above the upper reference value.

Procedure

The first 15 enrolled participants will undergo baseline tests, including A1c, creatinine and liver enzymes. At this time they will be instructed, in a group session, how to perform the four-day weighed food record and fill the satiety score sheets (Figure 1). Later, participants who meet the inclusion criteria will be notified about their final inclusion in the trial and reminded how to perform the four-day weighed food record and satiety score. Participants will borrow an electronic weighing scale with tare function and will be provided with enough sheets for the four-day weighed food record and satiety score. Five to seven days later, they will return the food records. The baseline four-day food record will yield information about the pre-study food choices and nutritional composition. The four-day food record and satiety score will be carried out at the start and end of each intervention period. After receiving the first food records, participants will be appointed for the first laboratory tests and intervention allocation. Based on total energy expenditure, as estimated by a bio-electrical impedance analyzer model BC-545 (Tanita Corporation, Tokyo, Japan), we will provide each participant with a menu plan with the approximate energy intake to avoid changes in body weight.
Figure 1
Figure 1

Four-day weighed food record and satiety score sheet.

Regarding insulin titration, the participant’s physician will handle insulin titration as needed.

Randomization

The study participants will be randomly allocated to start with either diet A or diet B. The process will be performed after the first laboratory testing. Randomization will be performed by use of an Internet-based random sequence generator from the School of Computer Science and Statistics, Trinity College, Dublin [http://www.random.org/sequences/]. Due to the small sample size, and to avoid unbalanced allocation of the participants to one of the starting diets, stratified sampling by use of minimization technique will be used. Weighting variables are starting diet and duration of T2DM [28].

Consent

Discussion

As discussed previously, there is uncertainty as to what is the optimal dietary approach for the prevention and treatment of T2DM [11, 12, 17], and previous trials from our group raise the question of whether focusing on the type of food, rather than macro/micronutrient composition, dietary fiber and GL is a better approach [21, 22]. The ADILAN study aims at comparing the effects of two healthy diets on the control of blood glucose, with no significant differences in macro/micronutrient composition, dietary fiber and GL, only different food choice. Importantly, we will try to eliminate weight loss as a confounding factor.

Of paramount importance, the nutritional software package (DIAL) used to create the seven-day menu plan generates a ‘Healthy Alimentation Index’ that classifies both diets as ‘very healthy’. Due to its specific design, constructed on evolutionary principles, the grain/dairy-free diet scored zero in two items, ‘Cereals and legumes’ and ‘Dairy’, but in spite of this, it was classified as very healthy owing to the fact that it scored the maximum (except for ‘Variety of foods with a score of 7/10) in the rest of items’, namely ‘Vegetables’, ‘Fruits’, ‘Meat, Fish and Eggs’, ‘Energy derived from fat’, ‘Energy derived from saturated fats’, ‘Cholesterol’, ‘Dietary sodium’ and ‘Variety of foods’ [32]. It can be concluded that the ADILAN study will compare two healthy diets which are similar in macro/micronutrient composition, fiber intake and GL, for the treatment of T2DM but differing in the intake of cereal grains, legumes and dairy products.

The ADILAN study could serve as a pilot study to run long-term dietary intervention trials in the future, focusing on food choice, which could shed light on a better dietary approach for prevention and treatment of T2DM.

Trial status

The ADILAN study is currently under recruitment process at 22 October 2013.

Abbreviations

A1c: 

Glycated hemoglobin

ADILA: 

Asociación de Diabéticos de Lanzarote

ADILAN: 

Alimentation and Diabetes in Lanzarote

AUC: 

Area under curve

GL: 

Glycemic load

IGT: 

Impaired glucose tolerance

MONICA: 

World Health Organization’s Multinational Monitoring of Trends and Determinants in Cardiovascular Disease protocol

OGTT: 

Oral glucose tolerance test

REDCap®: 

Research Electronic Data Capture

T2DM: 

Type 2 diabetes mellitus.

Declarations

Acknowledgements

The authors are grateful to Marci Acuña for continuous assistance in the logistics of the study and providing human resources, to María Montilla for helping in the laboratory analysis and arranging the meetings with the kitchen staff to create the meals, to the kitchen staff for preparing the meals and administering them to the participants, and to the Asociación de Diabéticos de Lanzarote (ADILA) for support in participant recruitment. This study received funding from the Excmo. Cabildo Insular de Lanzarote; Excmo. Ayuntamiento de Teguise and Excmo. Ayuntamiento de Arrecife. The Excmo. Cabildo Insular de Lanzarote will fund laboratory costs. The authors are very grateful to Felipa Villalba Díaz for helping in the design and testing the menu plan. The authors are also grateful to Ione Aguiar for his invaluable help in the design of the study protocol prior to be reviewed by the ethics committee, and for helping with the insurance contract.

Authors’ Affiliations

(1)
Department of Clinical Sciences, Center for Primary Health Care Research, Lund University/Region Skåne, Malmö, Sweden
(2)
Department of Food Technology, Engineering and Nutrition, Lund University, Lund, Sweden
(3)
Department of Medicine, Division of Nephrology, University of California San Francisco, San Francisco, CA, USA
(4)
Faculty of Health Sciences, Universidad de Las Palmas de Gran Canaria, Las Palmas de Gran Canaria, Spain
(5)
NutriScience-Education and Consulting, Lda, Lisbon, Portugal
(6)
Calle José Betancort, 15, 35530 Teguise-Lanzarote, Spain

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