Carbohydrate Distribution
A randomized crossover trial to investigate the effect of the distribution of carbohydrates over the day on postprandial glucose excursions in individuals with type 2 diabetes using continuous glucose monitoring for a 72 hour period.
Commonwealth Scientific Industrial Research Organisation, Human Nutrition
24 participants
Mar 6, 2006
Interventional
Conditions
Summary
The overall aim of this proposal is to demonstrate that blood sugar elevations are minimized through an even consumption of carbohydrates throughout the day. The study aims to clinically evaluate using an energy balanced diet, the effects of an even distribution of carbohydrate across the day in comparison with an uneven distribution on blood sugar elevations and the subsequent degree of hunger. Evaluation will primarily be based on continuous glucose monitoring using a Minimed continuous glucose monitoring system (CGMS) to provide a very detailed picture of the blood glucose profile.
Eligibility
Plain Language Summary
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This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.
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Interventions
The trial will consist of four treatments with 40% of the total energy from carbohydrate. Treatment 1: Carbohydrates evenly distributed throughout the day. Treatment 2: Carbohydrates (~ 64%) loaded at breakfast. Treatment 3: Carbohydrates (~ 62%) loaded at lunch. Treatment 4: Carbohydrates (~ 62%) loaded at dinner. In the treatment 1, the carbohydrates will be evenly distributed across the day while the energy distribution for breakfast, lunch and dinner will be approximately 25%, 25% and 50% of total energy for the day which reflects what is commonly observed in Australia. The remaining three treatments (2,3&4 will contain a meal which is “loaded” with carbohydrates i.e. the majority of carbohydrates (~ 63%) consumed for the day are consumed in that meal. To enable this to occur, the energy level of the “loaded” breakfast and lunch meals will be increased by ~ 11% and the corresponding remaining meals reduced by ~ 6% relative to treatment 1 & 4. Participants will be allocated the four treatments in a randomised order. Each 24 hour treatment will be repeated on three consecutive days (72 hours). The CGMS (Continuous Glucose Monitoring system) sensor will be inserted on Monday afternoon. Participants will be free to consume food of their choice for the remained of the day and asked to fast from 8pm that evening. The following day they will commence a given treatment for 72 hours. They will then return to the clinic on Friday morning to have the CGMS sensor removed and the data downloaded to a computer. All food and dietary advice will be provided to aid compliance. This process will complete one treatment. The following Monday they will return to the clinic and the routine repeated. The study should be completed in four consecutive weeks.
Locations(1)
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ACTRN12606000432516