Effects of Dietary Nitrate Intake on Physical Performance of Middle-aged Women

Study Overview
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Brief Summary
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Through a randomized, crossover, triple-blind, placebo-controlled clinical trial, 15 physically inactive hypertensive women will participate a 8-day trial, each with two intervention protocols: 1) placebo and 2) beetroot; in which will ingest beet juice with or without NO3 in its composition with a 8-day washout interval.

Official Title
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Effects of Dietary Nitrate Intake on Physical Performance of Middle-aged Women: a Randomized Trial

Conditions
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Postmenopausal; Menorrhagia, Physical Inactivity, Motor Activity

Intervention / Treatment
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* Dietary Supplement: Beetroot juice rich in nitrate
* Other: Beetroot juice NO3 depleted


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 50 to 65 years old Physically inactive Postmenopausal diagnosis (amenorrhea for 12 months or more); Exclusion Criteria: Smoking Cardiac failure Previous history of acute myocardial infarction and/or stroke; Allergy or intolerance to nitrate, gluten, or milk;

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Experimental (Beetroot juice NO3)<br>8-day supplementation with beetroot juice rich in NO3 (400mg) during 8 days. | Dietary Supplement: Beetroot juice rich in nitrate<br>* The participant will intake beetroot juice rich in NO3 (400mg) during 8-days. On the eighth day of the intervention, 2 hours after intake the last bottle of juice, the participants will return to the laboratory for the performance tests evaluation. Before crossover protocol a 7-day washout interval will be given for the purification of the compounds provided by the protocols.<br>|
| Placebo Comparator: Placebo (Beetroot juice without NO3)<br>8-day supplementation with beetroot juice NO3 depleted during 8 days. | Other: Beetroot juice NO3 depleted<br>* The participant will intake beetroot juice depleted in NO3. On the eighth day of the intervention, 2 hours after intake the last bottle of juice, the participants will to the laboratory for the performance tests evaluation. Before crossover protocol a 7-day washout interval will be given for the purification of the compounds provided by the protocols.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Handgrip strength test (kgf) |  | up to 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Six minute walk test (distance in meters) |  | up to 2 years | 
| Arm curl test (repetitions) |  | up to 2 years | 
| Sit-to-stand test (repetitions) |  | up to 2 years | 
| 8-foot up and go test (seconds) |  | up to 2 years |