The Effects of Breakfast Size on Hormonal Profile in Adults With Type 2 Diabetes Mellitus
Recruitment status was: Not yet recruiting
Studies has found a connection between breakfast consumption and obesity and obesity-related complications, but only few studies examined the effect of breakfast size.
The purpose of this study is to examine the effect of breakfast size on several parameters in adults with Type 2 diabetes mellitus.
|Study Design:||Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
- blood glucose balance [ Time Frame: three months ]HBA1C, C-peptid, insulin, glucose, HOMA-IR, Glycomark
- anthropometric parameters [ Time Frame: three months ]weight, height, body composition
- Adipokines and hormones [ Time Frame: three months ]insulin, leptin, ghrelin, adiponectin, GLP-1, cortisol
- pro-inflammatory cytokines [ Time Frame: three months ]TNF-α, IL-6, MCP-1, CRP
- lipid profile [ Time Frame: three months ]triglycerides, cholesterol, LDL, HDL
Dietary Supplement: breakfast size
The research group will receive instructions to eat a large breakfast, Dividing the total daily calories recommended to the patient to: breakfast - 1/8 of the total daily calories , lunch - 1/3 of the total daily calories and supper- 1/3 of the total daily calories.
(the rest of the calories will be snacks between the meals) In contrast, the control group that will receive instructions to eat a small breakfast.
Dividing the total daily calories recommended to the patient to: breakfast - 1/3 of the total daily calories , lunch - 1/4 of the total daily calories and supper- 1/4 of the total daily calories (the rest of the calories will snacks between the meals).
The instructions will be adapted to each patient individually
The prevalence of obesity has rapidly increased during recent decades, while the prevalence of skipping breakfast has increased.
Several studies have reported inverse relationships between the consumption of breakfast and BMI and weight gain. A study that examined the effect of breakfast size, found that an increased percentage of daily energy consumed at breakfast was associated with relatively lower weight gain. Preliminary results of clinical research (unpublished) show a connection between a large breakfast and weight loss and increased feeling of satiety throughout the day.
The purpose of this study is to examine the effect of breakfast size on blood glucose balance, and its correlation with hormonal profile (including appetite hormones), adipokines and pro-inflammatory cytokines, weight and body composition and lipid profile in adults with type 2 diabetes.
The study will use a randomized-controlled, non-blinded, prospective design, including 48 participants with type 2 diabetes, who are not insulin dependent.
The research group will receive instructions to eat a large breakfast compared with the control group that will receive instructions to eat a small breakfast.
The estimated duration of the study is about three months.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01178723
|Diabetes Unit, Wolfson Medical Center|
|Holon, Israel, 58100|