NCT04239482

Nutritional Supplementation and Insulin Sensitivity

Longer-term Effects of a Novel Nutritional Combination on Muscle Insulin Sensitivity and Mitochondrial Function, and Vascular Function in Abdominally Obese Subjects

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 1 (actual)
• Sponsor: Maastricht University Medical Center · Academic / Other
• Sex: All
• Age: 50 Years – 70 Years
• Healthy volunteers: Accepted

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.

Conditions

• Nitric Oxide
• Insulin Sensitivity
• Vascular Function
• L-arginine
• Nitrate / Nitrite

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	L-arginine + Nitrate / Nitrite	Longer-term supplementation (8 weeks)
DIETARY_SUPPLEMENT	Placebo	Longer-term supplementation (8 weeks)

Timeline

• Start date: 2020-09-01
• Primary completion: 2020-10-01
• Completion: 2020-10-01
• First posted: 2020-01-27
• Last updated: 2021-06-11

Locations

1 site across 1 country: Netherlands