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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.

Trials
January 1, 1970
Maelán Fontes-Villalba et al. (10 authors)
Journal ArticleRandomized Controlled TrialResearch Support, Non-U.S. Gov'tHuman StudyClinical
Study Details

Study Goal

The researchers aimed to compare the effects of two healthy diets—one with and one without cereal grains and dairy products—on glucose control in type 2 diabetes patients.

Results Summary

The abstract does not provide specific results regarding Dairy's effects, as the study is described as a pilot with primary outcomes focused on changes in fasting plasma glucagon and fructosamine.

Population

Adult patients with type 2 diabetes mellitus, with or without medication, and increased waist circumference (≥ 80 cm for women, ≥ 94 cm for men).

Effective Dosage

Not specified

Duration

Two 4-week intervention periods separated by a 6-week washout.

Interactions

None mentioned

Extracted Claims (2)
InterventionDirectionEndpointPopulationDosageImpactClaim #
food pattern mimicking the diet with which humans evolved
increase
glucose control and associated endocrine systems
-
-
positively influences
#1
two healthy diets with or without cereal grains and dairy products
neutral
glucose control
adult patients with a medical diagnosis of type 2 diabetes mellitus with or without medication and with an increased waist circumference
-
effect
#2
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.

Medical Subject Headings (MeSH)
BiomarkersBlood GlucoseBody WeightClinical ProtocolsCross-Over StudiesDairy ProductsDiabetes Mellitus, Type 2DietEdible GrainFemaleHumansMaleNutrition AssessmentNutritional StatusPilot ProjectsResearch DesignSpainTime FactorsTreatment Outcome
Study Links
Quality Scores
SafetyNot Assessed
Efficacy50/10
Quality75/10
0
Research Impact Scores
APT Score0.05
Weight Score1.28
Normalized Score0.55
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