Effect of Polyphenols Combined to L-citrulline on Ambulatory Blood Pressure
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional

Summary: 
      The general objective of this project is to investigate the chronic effect of consuming
      supplements combining polyphenols from cranberry and grape seed extracts and L-citrulline
      (Nitric Oxide Ultra capsules, Pure Encapsulations, Sudbury, MA) on 24-hour ambulatory blood
      pressure, markers of vascular function and plasma biomarkers of inflammation in adults with
      pre-hypertension.

      The study will be undertaken according to a double-blind, parallel, randomized, placebo
      controlled design and will be conducted at the Institute of Nutrition and Functional Foods
      (INAF) of Laval University. The study will involve a total of 73 adult men and women.
      Included subjects will be randomly assigned to a 6-week period of supplementation with Nitric
      Oxide (NO) Ultra capsules or placebo (cellulose capsules). The outcomes are the chronic
      changes after supplementation with NO Ultra capsules compared with the placebo in: 24-hour
      ambulatory diastolic and systolic blood pressure, levels of blood lipids and inflammation
      markers, levels of blood and cutaneous markers of vascular function.
    

Detailed description: 
      There is now evidence that blood pressure, vascular function and inflammation are intimately
      associated with cardiovascular disease. It is also clear that several dietary components
      including polyphenols and L-citrulline can modify blood pressure control. However, based on
      the studies available so far, it is difficult to draw firm conclusion on the potential impact
      of a dietary supplement combining polyphenols and L-citrulline on ambulatory blood pressure
      in pre-hypertensive subjects at risk to develop hypertension and cardiovascular disease. To
      the best of our knowledge, no study has yet investigated the chronic impact of combined
      polyphenols and L-citrulline on both ambulatory blood pressure and vascular
      function/inflammation.

      The present supplementation based on polyphenols and L-citrulline may represent for
      pre-hypertensive subjects a new dietary modality to manage blood pressure as part of healthy
      eating.

      The study will be undertaken according to a double-blind, parallel, randomized, placebo
      controlled design and will be conducted at the Institute of Nutrition and Functional Foods
      (INAF) of Laval University. A total of 73 adult men and women will be recruited based
      primarily on blood pressure criteria in the Quebec City metropolitan area. Participants will
      be randomly assigned to a 6-week period of supplementation with Nitric Oxide Ultra capsules
      or placebo (cellulose capsules). Participants in the NO Ultra group will be supplemented with
      764 mg/day of cranberry and grape seed extracts (containing polyphenols) and 2 g/day of
      L-citrulline. Participants will have to take daily 2 capsules (NO Ultra or placebo) between
      breakfast and lunch and 2 capsules (NO Ultra or placebo) between lunch and dinner.
      Specifically, capsules will be taken with water and no foods, and at least one-hour apart
      meals. Office and 24-hour ambulatory blood pressure, blood lipids, cutaneous and plasma
      markers of vascular function, plasma inflammation biomarkers and anthropometric
      characteristics will be measured at the beginning and at the end of the study.
    

Intervention name(s): NO Ultra; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 6-week supplementation period with 764 mg/day of cranberry and grape seed extracts (containing polyphenols) and 2 g/day of L-citrulline Participants will have to take daily 2 NO Ultra capsules (containing 382 mg cranberry and grape seed extracts / 1 g L-citrulline) between breakfast and lunch and 2 other NO Ultra capsules between lunch and dinner.; 6-week supplementation period with placebo capsules (the active ingredients will be replaced by cellulose)
Participants will have to take 2 capsules of cellulose between breakfast and lunch and 2 capsules between lunch and dinner to match the number of capsules ingested daily by the NO Ultra group.
Other intervention name(s): Cellulose capsules
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: 24h ambulatory blood pressure vascular function inflammation