None listed
Conditions
Brief 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.
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
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.
Sponsors
Commonwealth Scientific Industrial Research Organisation, Human Nutrition
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
30 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
Diagnosed with Type 2 Diabetes and have HAb1C greater than 6.5% (this will be tested)• Not have type 1 diabetes• Participants must understand the procedures involved and agree to participate in the study by giving full informed, written consent• No abnormality of clinical significance on medical history• If female, not pregnant or breast feeding.
Exclusion criteria
Unable to maintain current supplements or drug use at a stable dose for the 4 week period. (We will accept volunteers taking metformin, but exclude those taking appetite suppressants). • Have a malignancy, or a history of metabolic disease such as liver, kidney, or gastrointestinal disease• Inability to prepare meals or meet diet requirements• Unable to comprehend or cope with study requirements.
Outcome results
None listed