Interaction Between Inorganic Nitrate Supplementation and Metformin in Individuals With Prediabetes

Part of paid clinical trials in Charlottesville, Virginia.

Sponsor
University of Virginia
Study ID
NCT07131384
Status
Recruiting
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Conditions

  • Females
  • Males
  • Metformin
  • Prediabetes
  • Sedentary

Eligibility Criteria

Sex
ALL
Age
18 Years - 60 Years
Healthy Volunteers
Not accepted

Interventions

  • Dietary Supplement: Inorganic Nitrate (Beetroot juice) — DIETARY_SUPPLEMENT
    Participants will be supplemented with inorganic nitrate in the form of beetroot juice for 4 days (12.9 mmol of NO3/day), and their vascular health, insulin sensitivity, and exercise capacity will be measured post-supplementation. This is a randomized crossover design with 2 parallel groups (Group 1: Currently taking metformin, Group 2: Naive to metformin).
  • Dietary supplement: Placebo (Nitrate-depleted beetroot juice) — DIETARY_SUPPLEMENT
    Participants will be supplemented with nitrate-depleted beetroot juice for 4 days (\<0.01 mmol NO3/day), and their vascular health, insulin sensitivity, and exercise capacity will be measured post-supplementation. This is a randomized crossover design with 2 parallel groups (Group 1: Currently taking metformin, Group 2: Naive to metformin).

Study Details

This study is examining whether short-term supplementation with inorganic nitrate, in the form of beetroot juice, can enhance blood vessel health, insulin sensitivity, and exercise capacity in individuals with prediabetes. We will be comparing the responses in individuals who are taking metformin to those who are naive to metformin. The results from this study may help identify non-pharmacological interventions in prediabetes.

Key Dates

Start date
Jan 1, 2026
Status verified
Jun 2026
Primary completion
Jun 1, 2027
Completion
Jun 30, 2027

Study Design

Enrollment
24 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER

Arms

  • Experimental: Active Comparator (Naive to metformin)
    Participants will supplement with nitrate-rich beetroot juice (BRJ) for 4 days: 6.45 mmol of NO3 in the morning and 6.45 mmol in the evening for 3 days, and 12.9 mmol 2 hours before the lab visit. Supplement order based on randomization and crossover will happen after a minimum of a 7-day washout period.
  • Placebo Comparator: Placebo Comparator (Naive to metformin)
    Participants will supplement with nitrate-depleted beetroot juice (BRJ) for 4 days: 6.45 mmol of NO3 in the morning and 6.45 mmol in the evening for 3 days, and 12.9 mmol 2 hours before the lab visit. Supplement order based on randomization and crossover will happen after a minimum of a 7-day washout period.
  • Experimental: Active Comparator (Taking metformin)
    Participants will supplement with nitrate-rich beetroot juice (BRJ) for 4 days: 6.45 mmol of NO3 in the morning and 6.45 mmol in the evening for 3 days, and 12.9 mmol 2 hours before the lab visit. Supplement order based on randomization and crossover will happen after a minimum of a 7-day washout period.
  • Placebo Comparator: Placebo Comparator (Taking metformin)
    Participants will supplement with nitrate-depleted beetroot juice (BRJ) for 4 days: 6.45 mmol of NO3 in the morning and 6.45 mmol in the evening for 3 days, and 12.9 mmol 2 hours before the lab visit. Supplement order based on randomization and crossover will happen after a minimum of a 7-day washout period.

Primary Outcome Measure

Vascular Endothelial Function (Pulse wave analysis and velocity [PWA/V]) [ Time Frame: 3 days following either active NO3 or placebo without nitrate (following 7-day washout). ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of VirginiaCharlottesvilleVirginia22903
[email protected]
434-243-8677

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University of Virginia· Charlottesville, VA

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