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Completed

NCT Number: NCT01925248

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).

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Key information

Age range

25 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clinical and Translational Science Center Clinical Resources Center (CCRC)

Sacramento, California, 95655, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Whey Protein

Dietary Supplement

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

Placebo Group

Dietary Supplement

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

Primary outcomes

  1. Blood Glucose Level

    Time frame: each day up to 3 months

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

University of California, Davis

Other

Collaborators

  • National Center for Complementary and Integrative Health (NCCIH)
  • National Institutes of Health (NIH)

Registry information

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Aug 19, 2013
Registry last updated
May 30, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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