Nutritional Supplementation and Insulin Sensitivity

  • STATUS
    Recruiting
  • End date
    Jul 1, 2021
  • participants needed
    22
  • sponsor
    Maastricht University Medical Center
Updated on 26 January 2021

Summary

Type 2 diabetes mellitus (T2DM) is a progressive disease and early intervention and prevention strategies are therefore very important. An important early hallmark in the development of T2DM is insulin resistance. Since the majority of postprandial glucose disposal occurs in skeletal muscle, improving muscle insulin sensitivity will thus have a major impact on disease prevention. Abdominally obese men and women have an increased risk to develop T2DM, and are also characterized by an impaired vascular function. This may hamper proper delivery of insulin, glucose and oxygen to muscles, thereby contributing to - and possibly causing - muscle insulin resistance. Earlier it has been shown that supplementation with L- arginine improves vascular function by improving nitric oxide (NO) bioavailability. These NO- mediated beneficial effects on vascular function may improve delivery of insulin, glucose and oxygen to the muscle tissue, thereby improving muscle insulin sensitivity and mitochondrial function. However, the doses needed of this amino acid cannot be provided by regular diets or supplements, also due to the bitter taste of L-arginine. Alternatively, smaller amounts of L- arginine with a specific combination of other nutritional components (i.e. nitrate and nitrite), which are already part of the regular diet and support alternative pathways to improve NO- mediated vascular function, may also induce beneficial effects. The investigators now hypothesize that in abdominally obese adults with impaired fasting glucose concentrations L-arginine combined with nitrate/nitrite increases muscle insulin sensitivity.

Details
Condition Arginine, Nitric Oxide, Insulin Sensitivity, Vascular Function, Nitrate / Nitrite, Nitrate / Nitrite, l-arginine, Nitrate / Nitrite
Treatment Placebo, L-arginine + Nitrate / Nitrite
Clinical Study IdentifierNCT04239482
SponsorMaastricht University Medical Center
Last Modified on26 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age between 50 yrs and 70 yrs?
Gender: Male or Female
Do you have any of these conditions: Nitric Oxide or Arginine or Vascular Function or Nitrate / Nitrite or Insulin Sensitivity?
Do you have any of these conditions: l-arginine or Vascular Function or Nitrate / Nitrite or Insulin Sensitivity or Nitric Oxide or Arginine?
Aged between 50-70 years
Men and postmenopausal (two or more years after last menstruation) women
Waist circumference for men 3 102 cm and for women 3 88 cm (abdominally obese)
Impaired fasting glucose concentrations (between 5.6 - 7.0 mmol/L in accordance with the American Diabetes Association guidelines for prediabetes) at two screening visits
Fasting serum total cholesterol < 8.0 mmol/L
Stable body weight (weight gain or loss < 3 kg in the past three months)
Willingness to give up being a blood donor from 8 weeks before the start of the study, during the study and for 4 weeks after completion of the study
No difficult venipuncture as evidenced during the screening visit
Willingness to give up the use of antibacterial mouth wash or antibacterial toothpaste, chewing-gum and tongue-scraping during the study

Exclusion Criteria

Current smoker, or smoking cessation < 12 months
Diabetic patients
Familial hypercholesterolemia
Abuse of drugs
More than 3 alcoholic consumptions per day
Use of dietary supplements known to interfere with the main study outcomes as judged by the principal investigators
Use of anticoagulant drugs or drugs to treat blood pressure, lipid/glucose metabolism
Use of an investigational product within another biomedical intervention trial within the previous 1-month
Intolerance or allergy to the ingredients of the intervention products
Severe medical conditions that might interfere with the study, such as epilepsy, asthma, kidney failure or renal insufficiency, chronic obstructive pulmonary disease (COPD), inflammatory bowel diseases, auto inflammatory diseases and rheumatoid arthritis
Active cardiovascular disease like congestive heart failure or cardiovascular event, such as an acute myocardial infarction or cerebrovascular accident
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