NCT03743636

Nicotinamide Riboside With and Without Resveratrol to Improve Functioning in Peripheral Artery Disease

Nicotinamide Riboside With and Without Resveratrol to Improve Functioning in Peripheral Artery Disease: The NICE Trial

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 90 (actual)
• Sponsor: Northwestern University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

NICE is a randomized clinical trial that will examine the effects of nicotinamide riboside (NR) both with and without resveratrol to test whether, among people with PAD, NR significantly improves walking performance more than placebo and whether NR combined with resveratrol significantly improves walking performance more than placebo. If findings support the hypotheses, results will be used to design a large, definitive randomized clinical. The study will randomize 90 participants with PAD to one of the following three groups: NR + resveratrol, NR + placebo, or placebo + placebo.

Conditions

• Peripheral Artery Disease

Interventions

Type	Name	Description
DRUG	Nicotinamide riboside	Participants randomized to the NR + resveratrol arm or the NR + placebo arm of the study will receive 1,000 mg of NR daily for six months.
DRUG	Resveratrol	Participants randomized to the NR + resveratrol arm of the study will receive 125 mg of resveratrol daily for six months.
OTHER	Placebo	Participants randomized to the NR + placebo arm of the study will receiving placebo pills that are identical in appearance to resveratrol. Participants randomized to the placebo + placebo arm of the study will receive pills that are identical in appearance to NR and resveratrol. Participants will receive placebo pills daily for six months.

Timeline

• Start date: 2018-10-01
• Primary completion: 2023-05-23
• Completion: 2023-05-23
• First posted: 2018-11-16
• Last updated: 2025-01-14
• Results posted: 2025-01-14

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study