Evaluating the Metabolic Effects of Dietary Nitrate Supplementation (NCT05579262) | Clinical Trial Compass
CompletedNot Applicable
Evaluating the Metabolic Effects of Dietary Nitrate Supplementation
Singapore50 participantsStarted 2022-07-08
Plain-language summary
Dietary nitrate is found to enhance muscle fatty acid oxidation/glucose uptake and increase mitochondrial biogenesis, which in turn, aid in the prevention and management of metabolic diseases. In recent years, inorganic nitrate supplementation is clinically emerging as a therapeutic strategy for possible treatment and management of metabolic diseases and cardiometabolic disorders. This is mostly explored in healthy/obese subjects, for improving blood pressure, endothelial function, insulin response and vascular effects. However, the metabolic effects of dietary nitrate for improving skeletal muscle glucose/lipid metabolism, muscle mitochondrial metabolism, muscle blood flow and body fat composition are not comprehensively studied in diabetic/pre-diabetic subjects. Hence, this study aims to evaluate the therapeutic efficacy of a natural nitrate supplement (beetroot juice) for improving overall metabolic health in obese pre-diabetic and non-diabetic subjects.
Who can participate
Age range40 Years – 65 Years
SexMALE
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Inclusion criteria
✓. Males aged 40 - 65 years old, residing in Singapore
✓. Body mass index (BMI) 23 - 30 kg/m2
✓. Glucose metabolism: a. Normal group with having FPG \< 5.6 mmol/L and HbA1c \< 5.7, b. Pre-diabetes group FPG 5.6 to 6.9 mmol/L, and HbA1c \< 6.5 %.
✓. Willing to refrain from using oral mouth wash during study participation
✓. Willing to adhere to study protocol
Exclusion criteria
✕. Any current diagnosis or history of cardiovascular, hepatic, renal, metabolic (e.g. diabetes), gastrointestinal diseases, psychiatric disorders or diseases having impact on the study
✕. Suffering from current oral health conditions such as gum diseases, oral cancer or mouth injury
✕. Having medication and/or supplements which are known to influence glucose and insulin and muscle mitochondrial metabolism (e.g. Vitamin A, B, C and D, peroral corticosteroids)
✕
What they're measuring
1
Changes in skeletal muscle mitochondrial oxidative capacity
Timeframe: Baseline, Week 8, Week 16
2
Changes in skeletal muscle fuel rating
Timeframe: Baseline, Week 8, Week 16
3
Changes in insulin sensitivity in response to beetroot juice consumption via blood glucose measurements
Timeframe: Baseline, Week 16
4
Changes in insulin sensitivity in response to beetroot juice consumption via blood insulin measurements
Timeframe: Baseline, Week 16
Trial details
NCT IDNCT05579262
SponsorInstitute for Human Development and Potential (IHDP), Singapore