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Effect of Whey Protein Supplement on Plasma Glucose Levels in Japanese Patients with Inadequately Controlled Type 2 Diabetes

Effect of Whey Protein Supplement on Plasma Glucose Levels in Japanese Patients with Inadequately Controlled Type 2 Diabetes - Effect of Whey Protein Supplement on Plasma Glucose Levels

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000034160
Enrollment
70
Registered
2020-12-31
Start date
2018-10-01
Completion date
Unknown
Last updated
2026-06-29

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

Conditions

Type 2 diabetes

Interventions

Trained nutritionists calculate ideal body weight and assess their daily diet. Patients were instructed to add on 10% of total energy by whey protein supplement.

Sponsors

St. Marianna University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1)Outpatients. 2)HbA1c before clinical trial start is 7.0% or more and 8.0% less. 3)Over 20years old. Gender unquestioned. 4)Patients are being treated DPP-4 inhibitor for more than 6 months,and variation of HbA1c by <0.5% whithin 3 months before recruitment. 5)Written informed consent was obtained from all participants.

Exclusion criteria

Exclusion criteria: 1)Type1 diabetic patients and Type2 diabetic patients who depend on insulin. 2)Patients have renal failure (estimated glomerular filtration rate <60mL/min/1.73m2). 3)Patients have severe liver disfunction. 4)Women who may be pregnant, may become pregnant and are breastfeeding. 5)Patients have malignancy or had treated to malignancy past five years. 6)Patients have admission to improve glycemic control within a past year before written consent. 7)Patients are using a drug with the influence for glucose metabolism (steroid, interferon, hormone drugs, antipsychotic drugs and antitubercular drugs). 8)Patients have allergy to protein or dairy product. 9)Patients who were judged to be ineligible by the investigator.

Design outcomes

Primary

MeasureTime frame
The change of the HbA1c from baseline in the whey protein supplement performed after each 12 weeks

Secondary

MeasureTime frame
The change of the GA, GLP-1, GIP and PYY from baseline in the whey protein supplement performed after each 12 weeks And the change of body composition by the Bioelectrical Impedance Analysis

Countries

Japan

Contacts

Public ContactYutaro Yamamoto

St. Marianna University School of Medicine Division of Metabolism and endocrinology, Depertment of Internal Medicine

y3yamamoto@marianna-u.ac.jp044-977-8111

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026