Breakfast Clinical Trial
Official title:
Effect of Eating vs Skipping Breakfast on Postprandial Hyperglycemia After Subsequent Isocaloric Lunch and Dinner in Type 2 Diabetic Patients
Background: Skipping breakfast and/or overeating at evening, has been associated in type 2
diabetic (T2D) individuals, with higher BMI, visceral adiposity, hyperlipidemia, increased
overall postprandial glycemia (PPHG) and higher HbA1c. The absence of breakfast is also
associated with increased plasma free fatty acids (FFA) along the morning until lunch. High
plasma FFA in turn are triggering factor of insulin resistance, by inhibiting insulin
mediated glucose uptake in obese and T2D subjects The investigators therefore hypothesize
that compared to eating breakfast the prolonged overnight fasting caused by the breakfast
omission will result in increased postprandial glycemic response after subsequent isocaloric
lunch and dinner in T2D individuals.
Objectives: With this aim will study T2D patients in randomized crossover design to consume
in two separate days, either 3 standard isocaloric meals: Yes Breakfast condition (YesB) or
omit breakfast: no breakfast condition (NoB) and consume only lunch and dinner with the same
caloric content.
Methods and Study Design: The YesB intervention will consist on three identical meals
coating 700 Kcal each: breakfast at 8:00, lunch at 13:00 and dinner at 19:00. The NoB
intervention the breakfast will be omitted and the subject continue fasting until lunch.
Then the participants will consume identical 700 kcal Lunch at 13:00 and 700 Kcal dinners at
19:00. The investigators will assess plasma glucose, insulin, C-peptide, GLP-1 and FFA with
blood samples collected every 30 min up to 180 min after breakfast, lunch and dinner and at
the same time point the blood samples will be collected after 8:00 when the breakfast will
be omitted.
Expected results: The investigators expect that compared to NoB condition, in the YesB
condition the postprandial response after lunch and dinner will be reduced for glucose and
for FFA, while plasma insulin, C-peptide and GLP-1 postprandial response after lunch and
dinner will be enhanced
Background or Rationale Studies analyzing the postprandial glycemic response have shown that
glucose tolerance display a clear diurnal variation with a progressive decline in
carbohydrate tolerance toward the evening hours with more prolonged and higher postprandial
glycemic response in the evening than in the morning.
Meal timing patterns, on the other hand, exerts strong entraining influence on clock gene
regulation of hormones and enzymes i.e. insulin, GLP-1, involved in glucose metabolism and
postprandial glycemia disrupting the diurnal variation of postprandial glycemia (PPG). It
suggests the extent of post-prandial rise in plasma glucose depends not only upon the
quantity and nature of food ingested, and on the clock gene regulated circadian hormonal
rhythms, it also depends upon the metabolic state immediately prior to eating. Indeed, meal
schedule non-aligned with the clock gene circadian rhythms, such as skipping breakfast
and/or overeating at evening, has been associated, in T2D individuals, with higher BMI,
visceral adiposity, hyperlipidemia, higher HbA1c and increased PPG despite same caloric
intake. The absence of breakfast has been associated in obese and T2D subjects with
increased plasma levels of free fatty acids (FFA) along the morning until the lunch, Chronic
and acute increase of FFA plasma levels, has been reported as triggering factor of insulin
resistance, by inhibition of insulin mediated stimulated glucose uptake and/or
phosphorylation which develops 3-4 hours after raising of plasma FFA and by inhibition of
glycogen synthase, the rate limiting enzyme of glycogen synthesis, which develops 4-6 hours
after the rise of FFA. However the effect of eating vs skipping breakfast on postprandial
glucose response after identical lunch and dinner has not been explored. It is therefore
important to explore the influence of eating versus skipping breakfast on postprandial
glucose, after lunch and dinner in T2D individuals. Concomitantly the investigators will
assess after lunch and dinner plasma insulin, GLP-1 and FFA response after lunch and dinner
in T2D individuals.
Expected results: The investigators expect that compared skipping breakfast condition, the
eating breakfast condition will reduce postprandial plasma glucose and FFA response after
lunch and dinner, while plasma insulin, C-peptide and GLP-1 after lunch and dinner will be
enhanced Relevance of the study: If our hypothesis is confirmed it may be may be of
practical benefit to people with Type 2 diabetes, a condition in which the reduction of PPHG
at lunch and at dinner may result in improved HbA1c and might be also preventive of the risk
for CVD Objectives: With this aim will study T2D patients in randomized crossover design to
consume in two separate days, either 3 standard isocaloric meals: Yes Breakfast condition
(YesB) or omit breakfast: no breakfast condition (NoB) and consume only lunch and dinner
with the same caloric content.
Methods and Study Design: The YesB intervention will consist on three identical meals
coating 700 Kcal each: breakfast at 8:00, lunch at 13:00 and dinner at 19:00. The NoB
intervention the breakfast will be omitted and the subject continue fasting until lunch.
Then the participants will consume identical 700 kcal Lunch at 13:00 and 700 Kcal dinners at
19:00. The investigators will assess plasma glucose, insulin, C-peptide, GLP-1 and FFA with
blood samples collected every 30 min up to 180 min after breakfast, lunch and dinner and at
the same time point the blood samples will be collected after 8:00 when the breakfast will
be omitted.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT03045354 -
Dietary Carbohydrate Consumption at Breakfast on Food Intake, Glycemic Response, and Subjective Appetite
|
N/A | |
| Completed |
NCT05120440 -
The Effect of Breakfast Consumption on Afternoon Resistance Training Performance
|
N/A | |
| Completed |
NCT03134014 -
High Protein Breakfast on Weight Management and Glycemic Control in 'Breakfast-skipping' Teens
|
N/A | |
| Completed |
NCT03637010 -
Purdue Study for the Benefits of Breakfast in the Classroom
|
N/A | |
| Recruiting |
NCT03681587 -
How to Give Back the Pleasure of Eating to the Dependent Elderly
|
||
| Completed |
NCT03536676 -
Benefits of a Higher Protein, 'Egg-cellent' Breakfast in the Classroom
|
N/A |