Clinical and Translational Science Center Clinical Resources Center (CCRC)
Sacramento, California, 95655, United States
NCT Number: NCT01925248
The purpose of this study is to investigate whether intake of protein supplement just before meals lowers the blood sugar levels after the meals. It is believe that pre-meal administration of a high-protein supplement can effectively improve glycemic control in type 2 diabetes (DM).
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Notify Me25 year–70 year
All sexes
Interventional
Not applicable
Sacramento, California, 95655, United States
11.3% of the population aged 20 years or older (25.6 million individuals) has diabetes. In the population aged 65 years or older, the prevalence of diabetes reaches to 26.9%.
Type 2 DM is caused by insulin resistance accompanied by insufficient compensatory insulin response. Therefore insulin secretagogues are a significant component of the therapeutic armamentarium. Insulin secretagogues, such as sulphonylureas and meglitinides, are routinely prescribed to lower post prandial glucose levels in type 2 DM. However, these medications are cleared by the liver and the kidneys and cannot be used in the presence of relevant co-morbidities. These medicines can also cause side effects, including hypoglycemia. Limitations of these medicines are likely to lead diabetic patients and their health care providers to seek alternate methods to treat postprandial hyperglycemia. Thus, our research which aims to identify an alternate insulin secretagogue is important and timely.
Whey protein (WP), a rich source of essential and branch chain (BC) amino acids (AA), is a potent insulin secretagogue. Although it is well known that protein and/or AA intakes stimulate insulin secretion, protein supplements are not being used clinically in order to lower post-prandial glycemia. WP can be a satisfactory alternative to the pharmaceutical insulin secretagogues.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Whey protein group participants will take supplement drinks that contain whey protein, daily before breakfast and before dinner for 3 months.
Placebo group participants will take supplement drinks that do not contain whey protein, daily before breakfast and before dinner for 3 months.
Time frame: each day up to 3 months
Time frame: baseline and 1 month up to 3 months
Time frame: 1 month up to 3 months
Time frame: 1 month up to 3 months
Time frame: 1 month up to 3 months
Time frame: baseline and 1 month up to 3 months
Time frame: baseline and 1 month up to 3 months
Time frame: baseline and 1 month up to 3 months
Time frame: baseline and 1 month up to 3 months
Time frame: baseline and 1 month up to 3 months
Time frame: baseline and 1 month up to 3 months
Time frame: baseline and 1 month up to 3 months
University of California, Davis
Other
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