Can Whey Protein Improve Glycemic Control in Type 2 Diabetes?

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).

Study Overview

• Status: Completed
• Conditions: Hyperglycemia; Type 2 Diabetes Mellitus
• Intervention / Treatment: Dietary supplement: Whey protein; Dietary supplement: Placebo group

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Sacramento, California, United States, 95655
      • Clinical and Translational Science Center Clinical Resources Center (CCRC)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Whey protein group; Patients will be randomized to receive whey protein	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_COMPARATOR: Placebo group; Patients will be randomized to receive placebo	Dietary supplement: Placebo group; Placebo group participants will take supplement drinks that do not contain whey protein, daily before breakfast and before dinner for 3 months.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Blood Glucose Level	each day up to 3 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Change in 24 hour urine C-peptide excretion level	baseline and 1 month up to 3 months
Change in Weight	1 month up to 3 months
Change in Body Mass Index (BMI)	1 month up to 3 months
Change in vital signs	1 month up to 3 months
Change in DEXA	baseline and 1 month up to 3 months
Change in Free fatty acids (FFA) levels	baseline and 1 month up to 3 months
Change in Lipid levels	baseline and 1 month up to 3 months
Change in GLP-1 levels	baseline and 1 month up to 3 months
Change in hs-CRP levels	baseline and 1 month up to 3 months
Change in Glycated hemoglobin (HgBA1C) level	baseline and 1 month up to 3 months
Change in Urine glucose level	baseline and 1 month up to 3 months

Collaborators and Investigators

• Sponsor: University of California, Davis
• Collaborators: National Institutes of Health (NIH); National Center for Complementary and Integrative Health (NCCIH)
• Investigators: Principal Investigator: Sidika E Kasim-Karakas, M.D., University of California, Davis

Study record dates

Study Major Dates

• Study Start: July 1, 2013
• Primary Completion (ACTUAL): June 1, 2016
• Study Completion (ACTUAL): June 1, 2016

Study Registration Dates

• First Submitted: July 31, 2013
• First Submitted That Met QC Criteria: August 15, 2013
• First Posted (ESTIMATE): August 19, 2013

Study Record Updates

• Last Update Posted (ACTUAL): May 30, 2017
• Last Update Submitted That Met QC Criteria: May 24, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Keywords: Diabetes; Type 2 DM; Hyperglycemia; Whey protein; protein supplement; Insulin secretagogue
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Hyperglycemia; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: 474534; A-13-001-UCD-SK-NH (OTHER_GRANT: California Dairy research Foundation)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO