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Can Whey Protein Improve Glycemic Control in Type 2 Diabetes?

Can Whey Protein Improve Glycemic Control in Type 2 Diabetes?

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01925248
Enrollment
32
Registered
2013-08-19
Start date
2013-07-31
Completion date
2016-06-30
Last updated
2017-05-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hyperglycemia, Type 2 Diabetes Mellitus

Keywords

Whey protein, protein supplement, Diabetes, Type 2 DM, Hyperglycemia, Insulin secretagogue

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).

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.

Interventions

DIETARY_SUPPLEMENTPlacebo group

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

DIETARY_SUPPLEMENTWhey protein

Whey protein group participants will take supplement drinks that contain whey protein, daily before breakfast and before dinner for 3 months.

Sponsors

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

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
25 Years to 70 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
Blood Glucose Leveleach day up to 3 months

Secondary

MeasureTime frame
Change in DEXAbaseline and 1 month up to 3 months
Change in Free fatty acids (FFA) levelsbaseline and 1 month up to 3 months
Change in Lipid levelsbaseline and 1 month up to 3 months
Change in GLP-1 levelsbaseline and 1 month up to 3 months
Change in hs-CRP levelsbaseline and 1 month up to 3 months
Change in vital signs1 month up to 3 months
Change in Urine glucose levelbaseline and 1 month up to 3 months
Change in 24 hour urine C-peptide excretion levelbaseline and 1 month up to 3 months
Change in Weight1 month up to 3 months
Change in Body Mass Index (BMI)1 month up to 3 months
Change in Glycated hemoglobin (HgBA1C) levelbaseline and 1 month up to 3 months

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026