Can Whey Protein Improve Glycemic Control in Type 2 Diabetes?

Type 2 Diabetes Mellitus Clinical Trial

Official title:

Can Whey Protein Improve Glycemic Control in Type 2 Diabetes?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01925248
• Other study ID #: 474534
• Secondary ID: A-13-001-UCD-SK-
• Status: Completed
• Phase: N/A
• First received: July 31, 2013
• Last updated: May 24, 2017
• Start date: July 2013
• Est. completion date: June 2016

Study information

• Verified date: May 2017
• Source: University of California, Davis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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).

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 25 Years to 70 Years

Eligibility

Inclusion Criteria:

• Men and women with type 2 DM; age: 25 to 70y; BMI: 25 - 40 kg/m2; on no drug treatment or on metformin alone; HgBA1 6.5 - 8.5%; urinary microalbumin < 30 mg/g cr.

Exclusion Criteria:

• Systemic disease (liver, renal, untreated hypothyroidism, etc); in the last 2 mo: > 5% weight change, smoking, alcohol intake > 4 /wk; restricted diets; medications or herbals affecting insulin secretion/sensitivity . Pregnant women, prisoners, individuals who cannot provide informed consent.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Hyperglycemia
• Type 2 Diabetes Mellitus

Intervention

Dietary Supplement:
• Whey protein
Whey protein group participants will take supplement drinks that contain whey protein, daily before breakfast and before dinner for 3 months.
• Placebo group
Placebo group participants will take supplement drinks that do not contain whey protein, daily before breakfast and before dinner for 3 months.

Locations

Country	Name	City	State
United States	Clinical and Translational Science Center Clinical Resources Center (CCRC)	Sacramento	California

Sponsors (3)

Lead Sponsor	Collaborator
University of California, Davis	National Center for Complementary and Integrative Health (NCCIH), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood Glucose Level		each day up to 3 months
Secondary	Change in 24 hour urine C-peptide excretion level		baseline and 1 month up to 3 months
Secondary	Change in Weight		1 month up to 3 months
Secondary	Change in Body Mass Index (BMI)		1 month up to 3 months
Secondary	Change in vital signs		1 month up to 3 months
Secondary	Change in DEXA		baseline and 1 month up to 3 months
Secondary	Change in Free fatty acids (FFA) levels		baseline and 1 month up to 3 months
Secondary	Change in Lipid levels		baseline and 1 month up to 3 months
Secondary	Change in GLP-1 levels		baseline and 1 month up to 3 months
Secondary	Change in hs-CRP levels		baseline and 1 month up to 3 months
Secondary	Change in Glycated hemoglobin (HgBA1C) level		baseline and 1 month up to 3 months
Secondary	Change in Urine glucose level		baseline and 1 month up to 3 months