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Official title The Combined Effect of Dietary Nitrate and Caloric Restriction on Cognitive and Vascular Function.
ClinicalTrials.gov ID: NCT06151015
What this study is testing
- What it's testing
- This pilot study will compare the effect of combining dietary nitrate and caloric restriction versus dietary nitrate alone. The participant will be contacted, having responded to an advertisement on social media and posters, to attend the screening visit.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 60 to 75. Healthy volunteers may be eligible.
You may be able to join if
- Participant is able to give written informed consent for their participation in the study.
- Healthy.
- Non-smoking adults.
- Male or female.
- Aged 60 to 75 years.
You likely can't join if
- Systolic BP \> 180mmHg and/or diastolic BP \>110mmHg at the Clinic Screening Visit.
- Contraindication for MRI.
- Does not have adequate understanding of verbal and written information in English, sufficient to complete an MRI safety screening and to give...
- Any existing or previous medical condition that may affect the study outcomes (i.e., diabetes, kidney dysfunction, malignant cancer, brain surgery...
- Any medical treatment that may affect the study outcomes (i.e., diuretics, anti-acids, organic nitrates, anti-pyschotics or neuro-stimulants).
- Evidence of an eating disorder as indicated by the Three-factor eating questionnaire (Eating Attitudes Tests-26).
See the full eligibility criteria
- Participant is able to give written informed consent for their participation in the study.
- Healthy.
- Non-smoking adults.
- Male or female.
- Aged 60 to 75 years.
- BMI between 25 and 40 kg/m2.
- Systolic BP \> 180mmHg and/or diastolic BP \>110mmHg at the Clinic Screening Visit.
- Contraindication for MRI.
- Does not have adequate understanding of verbal and written information in English, sufficient to complete an MRI safety screening and to give informed consent.
- Any existing or previous medical condition that may affect the study outcomes (i.e., diabetes, kidney dysfunction, malignant cancer, brain surgery, stroke).
- Any medical treatment that may affect the study outcomes (i.e., diuretics, anti-acids, organic nitrates, anti-pyschotics or neuro-stimulants).
- Evidence of an eating disorder as indicated by the Three-factor eating questionnaire (Eating Attitudes Tests-26).
- Blood donation within the last 3 months of the anticipated intervention beginnings.
- Having taken part in a research study in the last 3 months involving invasive procedures or an inconvenience allowance.
- High-alcohol consumers (≥ 14 units/week for females, and ≥ 22 units/week for males).
- Vegetarianism (likely to have very high nitrate intake and food provided during the dietary intervention unsuitable).
- Weight change over 3.0kg in the last 2 months (important influence on vascular function).
The study team makes the final eligibility decision.
Where it's taking place
- Nottingham, Nottinghamshire, United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 60 years to 75 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Nottingham, Nottinghamshire, United Kingdom. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.