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Can Whey Protein Improve Glycemic Control in Type 2 Diabetes?

This study has been completed.
Sponsor:
Collaborators:
National Institutes of Health (NIH)
National Center for Complementary and Integrative Health (NCCIH)
Information provided by (Responsible Party):
University of California, Davis
ClinicalTrials.gov Identifier:
NCT01925248
First received: July 31, 2013
Last updated: May 24, 2017
Last verified: May 2017
  Purpose
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).

Condition Intervention
Type 2 Diabetes Mellitus Hyperglycemia Dietary Supplement: Whey protein Dietary Supplement: Placebo group

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Investigator
Primary Purpose: Treatment
Official Title: Can Whey Protein Improve Glycemic Control in Type 2 Diabetes?

Further study details as provided by University of California, Davis:

Primary Outcome Measures:
  • Blood Glucose Level [ Time Frame: each day up to 3 months ]

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

Enrollment: 32
Study Start Date: July 2013
Study Completion Date: June 2016
Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   25 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01925248

Locations
United States, California
Clinical and Translational Science Center Clinical Resources Center (CCRC)
Sacramento, California, United States, 95655
Sponsors and Collaborators
University of California, Davis
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
  More Information

Responsible Party: University of California, Davis
ClinicalTrials.gov Identifier: NCT01925248     History of Changes
Other Study ID Numbers: 474534
A-13-001-UCD-SK-NH ( Other Grant/Funding Number: California Dairy research Foundation )
Study First Received: July 31, 2013
Last Updated: May 24, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by University of California, Davis:
Whey protein
protein supplement
Diabetes
Type 2 DM
Hyperglycemia
Insulin secretagogue

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Hyperglycemia
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on July 21, 2017