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Can Whey Protein Improve Glycemic Control in Type 2 Diabetes?

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ClinicalTrials.gov Identifier: NCT01925248
Recruitment Status : Completed
First Posted : August 19, 2013
Last Update Posted : May 30, 2017
Sponsor:
Collaborators:
National Institutes of Health (NIH)
National Center for Complementary and Integrative Health (NCCIH)
Information provided by (Responsible Party):
University of California, Davis

Brief 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).

Condition or disease Intervention/treatment
Type 2 Diabetes Mellitus Hyperglycemia 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  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Can Whey Protein Improve Glycemic Control in Type 2 Diabetes?
Study Start Date : July 2013
Primary Completion Date : June 2016
Study Completion Date : June 2016

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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.



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

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


Information from the National Library of Medicine

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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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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 )
First Posted: August 19, 2013    Key Record Dates
Last Update Posted: May 30, 2017
Last Verified: May 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