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临床试验/NCT07310225
NCT07310225已完成不适用

The Effect of the Mediterranean Diet on Metabolic Parameters in Individuals With Type 2 Diabetes: A Comparative Evaluation With the DASH and MIND Diets

Abant Izzet Baysal University1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2024年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
90
试验地点
1
主要终点
Questionnaire Form

研究概览

简要总结

In our study, we aimed to comparatively evaluate the relative effects of the Mediterranean, DASH, and MIND diets on metabolic parameters in individuals with type 2 diabetes. The study was conducted on 90 individuals diagnosed with T2DM according to the American Diabetes Association diagnostic criteria (fasting blood glucose ≥ 126 mg/dL, 2-hour blood glucose ≥ 200 mg/dL during an oral glucose tolerance test (OGTT), or HbA1c ≥ 6.5% (48 mmol/mol)). Volunteers who participated in the study completed a questionnaire form that included sociodemographic characteristics. In addition, participants' anthropometric measurements (body weight (BW), height, waist circumference (WC), hip circumference (HC), body mass index (BMI)), biochemical parameters (fasting blood glucose, hbA1c (%), LDL-cholesterol, triglycerides, total cholesterol), Visceral Adiposity Index (VAİ), body composition analyses (Fat Mass (FM (%), Fat-Free Mass (FFM) (kg), Basal Metabolic Rate (BMR) (kcal), Visceral Fat Area (VFA) (%)), nutritional status (food consumption frequency, food consumption record, Mediterranean Diet Scale, DASH diet adherence score, and MIND diet adherence score) were evaluated.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

年龄范围
19 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Individuals over 19 years of age
  • Individuals who are literate
  • Individuals diagnosed with Type 2 diabetes

排除标准

  • Individuals who have had an acute infection or inflammatory disease within the past month
  • Individuals with chronic infectious or inflammatory diseases
  • Individuals with cancer

结局指标

主要结局

Questionnaire Form

时间窗: 9 months

Sociodemographic characteristics of the individuals (age, gender, smoking and alcohol use) were questioned.

Body Weight (BW)

时间窗: 9 months

BW was measured using a calibrated digital scale placed on a flat, tiled surface. The scale was sensitive to 100 grams.

Body Mass Index (BMI)

时间窗: 9 months

BMI was calculated by dividing body weight (in kilograms) by the square of height (in meters): BMI = weight (kg) / height² (m²).

Fasting Blood Glucose

时间窗: 9 months

Fasting blood glucose was measured using standard laboratory techniques during routine outpatient visits.

Height

时间窗: 9 months

Height was measured using a stadiometer with the participant's head positioned in the Frankfort plane and feet placed together.

Waist Circumference (WC)

时间窗: 9 months

WC was measured at the midpoint between the lowest rib and the iliac crest (cristal point) using a flexible measuring tape.

Hip Circumference (HC)

时间窗: 9 months

HC was measured at the widest point of the hips using a flexible measuring tape.

Triglycerides

时间窗: 9 months

Triglyceride levels were measured via fasting blood samples analyzed in the outpatient clinic laboratory.

LDL-Cholesterol

时间窗: 9 months

LDL-cholesterol was measured from fasting serum samples using standard enzymatic colorimetric methods.

Total Cholesterol

时间窗: 9 months

Total cholesterol was measured using routine biochemical analysis in a certified laboratory.

HbA1c (%)

时间窗: 9 months

Fasting blood glucose was measured using standard laboratory techniques during routine outpatient visits.

Body Fat Mass (FM) (%)

时间窗: 9 months

Obtained using a bioelectrical impedance analysis (BIA) device (Tanita Innerscan BC 401, Japan).

Basal Metabolic Rate (BMR) (kcal)

时间窗: 9 months

Bioelectrical impedance analysis (BIA) device (Tanita Innerscan BC 401, Japan) was used.

DASH diet compliance

时间窗: 9 months

Individuals' DASH diet compliance scores were calculated based on their food consumption frequency after their energy requirements were calculated. The highest possible score on the DASH diet compliance scale is 8.0. A score of 4.5 or above is considered 'high compliance', while a score below 4.5 is considered 'low compliance'.

Abdominal obesity index (VAI)

时间窗: 9 months

Abdominal obesity index (VAI): VAI has been used to assess abdominal obesity. VAI (Men) = \[Waist circumference (cm) / (36.58 + (1.88 × BMI)\] × (triglycerides / 1.03) × (1.31 / HDL-C) , VAI (Women) = \[Waist circumference (cm) / (36.58 + (1.88 × BMI)\] × (triglycerides / 0.81) × (1.52 / HDL-C)

Fat-Free Mass (FFM) (kg)

时间窗: 9 months

bioelectrical impedance analysis (BIA) device (Tanita Innerscan BC 401, Japan).

Visceral Fat Area (VFA) (%)

时间窗: 9 months

Bioelectrical impedance analysis (BIA) device (Tanita Innerscan BC 401, Japan).

Food consumption frequency

时间窗: 9 months

Participants were asked about the foods they consumed in the past month from seven groups, including five basic food groups (meat and meat products, milk and dairy products, bread and grains, vegetables and fruits, sugars and fats), beverages, and fast food. Participants were asked how often and in what quantities they consumed these foods using eight options: "every meal," "every day," "5-6 days a week," "3-4 days a week," "1-2 days a week," "once every 15 days," "once a month," and "never." In evaluating food consumption records, responses regarding food consumption frequency were calculated using food consumption frequency. The amounts of food and beverages consumed were multiplied by "3" for "every meal," '1' for "every day," "0.7855" for "5-6 times a week," "0.498" for "3-4 times a week," "0.2145" for "1-2 times a week," "0.067" for "once every 15 days," and "0.033" for "once a month" to obtain the daily average amounts.

Food consumption record

时间窗: 9 months

A single-day food consumption record was obtained using the 24-hour recall method to determine participants' food consumption patterns. The Food and Nutrition Photo Catalog was used to estimate portions to ensure that the amounts of food consumed were assessed accurately and reliably. Based on these records, daily energy and nutrient intakes were calculated using the Nutrition Information System (BEBİS) software, based on the type and amount of food consumed by individuals in the last 24 hours.

Mediterranean diet adherence scale

时间窗: 9 months

The Mediterranean Diet Scale was used to determine individuals' adherence to the Mediterranean diet. This scale consists of a total of 14 questions, 2 of which relate to food consumption habits and 12 of which relate to food consumption frequency. Each question is scored as either 0 or 1 point. The scale's scoring range is set at 0-14 points.

MIND diet compliance score

时间窗: 9 months

It includes a total of 15 different food groups, consisting of ten groups that protect brain health and five groups that harm brain health. Individuals' food consumption records and frequency of food consumption were examined, and the consumption amounts of foods belonging to these 15 groups were divided into portions and evaluated according to the scoring system. This scale is scored from 0 to 15, and there is no cutoff point for determining compliance with the MIND diet.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Nurefşan KONYALIGİL ÖZTÜRK

Assist. Prof. Dr

Abant Izzet Baysal University

研究点 (1)

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