RecruitingNot applicable

Whey Protein Ingestion and Glucose Control in Pre- and Post Diabetic Individuals

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
50 Years to 70 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests how drinking whey protein, a protein from milk, twice a day affects blood sugar and insulin. It is for adults ages 50–70 with prediabetes or diabetes.

To examine the effects of twice daily whey protein consumption on blood glucose and insulin in pre-diabetic and diabetic individuals

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Are age 50–70.
  • Have a body mass index (BMI), a measure of weight compared with height, between 25 and 45.
  • Can understand the study and agree to take part.
  • Test negative for COVID-19 and/or have no symptoms.
  • Will avoid alcohol, marijuana, and CBD products during two separate 7-day study meal periods.
  • Have an HbA1c (a measure of average blood sugar) of 5.7–6.4% or 6.5–7.5%, or fasting blood sugar of at least 100 mg/dL.

Who can't join

  • Cannot or will not eat dairy protein, or have lactose intolerance (trouble digesting milk sugar).
  • Use insulin injections, GLP/GIP injections, or other medicines that reduce appetite.
  • Will not keep a detailed food diary or wear a continuous glucose monitor (CGM), a device that tracks blood sugar, for two separate 7-day periods and share the readings.
  • Have hemoglobin below 10 g/dL at screening. Hemoglobin is the protein in red blood cells that carries oxygen.
  • Had chemotherapy or radiation for cancer in the past 6 months, or have had surgery to bypass or reduce the stomach or intestines.
  • Are pregnant or breastfeeding, or have a long-term disease that causes inflammation, such as lupus or Crohn’s disease.
  • Use androgen hormones such as testosterone, growth-related hormones such as GH or IGF-I, or steroid medicines such as prednisone.
  • Will not stop protein or amino-acid supplements or go without food overnight, or have a health condition or medicine that the study team finds makes participation unsuitable.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: 1. Males and females ages 50-70 years. 2. Body mass index between 25-45 kg/m2 3. Capable of providing informed consent. 4. COVID-19 negative and/or asymptomatic. 5. Willing to abstain from drinking alcohol or consuming marijuana and CBD products during the 7-day study meal period on two occasions. 6. HbA1c: 5.7-6.4% or 6.5% to 7.5% or fasting glucose ≥100 mg/dL Exclusion Criteria: 1. Subject who does not/will not eat dairy protein sources. 2. Subjects taking exogenous insulin injections or GLP /GIP injections or other appetite suppressants. 3. Unwilling to keep a detailed 7 day food journal on two occasions 4. Unwilling to wear a CGM for 7 days on two occasions and share the data with the research team. 5. Lactose intolerance. 6. Hemoglobin \<10g/dL at screening. 7. History of chemotherapy or radiation therapy for cancer in the 6 months prior to enrollment. 8. History of gastrointestinal bypass/reduction surgery. 9. Pregnant or lactating individuals. 10. History of a chronic inflammatory disease (e.g. Lupus, Crohn's disease) 11. Currently receiving androgen (e.g., testosterone) or anabolic (e.g., GH, IGF-I) therapy. 12. Currently using corticosteroid medications (cortisone, hydrocortisone, prednisone, etc.). 13. Unwilling to avoid using protein or amino-acid supplements during participation. 14. Unwilling to fast overnight. 15. Any medical condition or medication that the PI or clinical study staff finds contradictory to this study.

Study sites (1)

AR