CompletedNot Applicable

Medium Chain Triglycerides (MCT) and Whey Protein Isolate (WPI) for Type 2 Diabetes Patients (Combine)

United Kingdom22 participantsStarted 2021-04-30

Plain-language summary

Evaluation of effect on diurnal glycaemia following consumption of MCT and whey protein in patients with type 2 diabetes

Age range25 Years – 65 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Male or female subjects, 25 to 65 years of age, inclusive.
✓. Subjects with a BMI of ≤ 40kg/m2.
✓. Established diagnosis of Type 2 diabetes mellitus (T2DM), documented by either HbA1c 6.5 -10.0% or active therapy with metformin at a daily dose of up to 3000 mg at screening.
✓. Willing and able to sign written informed consent prior to study entry.
✓. Subjects with laboratory parameters within normal range, or showing no clinically relevant deviations, as judged by the investigator.
✓. Willing and able to comply with the requirements of the study protocol.

✕. Fasting blood glucose \>11mmol/L at screening.
✕. Elevated liver transaminases \> 3 Upper limit of normal at screening.
✕. Ongoing or recent (i.e. \< 3month) insulin therapy.
✕. Ongoing or recent (i.e. \< 3month) GLP-1 therapy.
✕. Ongoing or recent (i.e. \< 3month) treatment with any oral or injectable glucose-lowering drug other than metformin.
✕. Ongoing or recent weight loss interventions (e.g. dietary weight loss programmes) or any history of bariatric surgery.
✕. Ongoing treatment with anorectic drugs, steroids, medications known to affect gastric motility, or any condition known to affect gastro-intestinal integrity and food absorption.
✕. Major medical/surgical event requiring hospitalization in the last 3 months.

Diurnal glucose Incremental area under curve (iAUC) concentrations

Timeframe: 115 days

NCT IDNCT04905589

SponsorSociété des Produits Nestlé (SPN)

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2022-08-01

Who can participate

Age range25 Years – 65 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Male or female subjects, 25 to 65 years of age, inclusive.
✓. Subjects with a BMI of ≤ 40kg/m2.
✓. Established diagnosis of Type 2 diabetes mellitus (T2DM), documented by either HbA1c 6.5 -10.0% or active therapy with metformin at a daily dose of up to 3000 mg at screening.
✓. Willing and able to sign written informed consent prior to study entry.
✓. Subjects with laboratory parameters within normal range, or showing no clinically relevant deviations, as judged by the investigator.
✓. Willing and able to comply with the requirements of the study protocol.

✕. Fasting blood glucose \>11mmol/L at screening.
✕. Elevated liver transaminases \> 3 Upper limit of normal at screening.
✕. Ongoing or recent (i.e. \< 3month) insulin therapy.
✕. Ongoing or recent (i.e. \< 3month) GLP-1 therapy.
✕. Ongoing or recent (i.e. \< 3month) treatment with any oral or injectable glucose-lowering drug other than metformin.
✕. Ongoing or recent weight loss interventions (e.g. dietary weight loss programmes) or any history of bariatric surgery.
✕. Ongoing treatment with anorectic drugs, steroids, medications known to affect gastric motility, or any condition known to affect gastro-intestinal integrity and food absorption.
✕. Major medical/surgical event requiring hospitalization in the last 3 months.