The Combined Effect of Dietary Nitrate and Caloric Restriction on Cognitive and Vascular Function.

NCT06151015 | Recruiting

• 1 other identifier: 323-0723
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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. They will be asked about their health status, suitability for MRI and availability. The investigators will use physical activity and eating attitude questionnaires. The investigators will also measure their height, weight, body mass index (BMI), and blood pressure (BP) and undertake blood tests. If they are eligible, they will be randomised to one of the two arms. The first group will consume nitrate-rich beetroot juice with a calorie-restricted diet for 28 days. The second group will drink the same juice with a weight-maintenance diet for the same period. The food and drinks will be provided. The outcome measures will be measured twice (at the baseline and end visits) to evaluate the change. The primary outcome is the cognitive function. The secondary outcomes are peripheral vascular health (BP and microvascular perfusion), cerebral vascular health (brain blood flow), anthropometry, body composition, and exhaled NO and nitrate concentrations. Also, the feasibility and accessibility of the study will be assessed.

Conditions

Healthy; Older Adults; Overweight and Obesity

Outcome Measures

Primary Outcomes (1)

• Cognitive function (TMT-B)

  Change in cognitive function from the baseline after 28 days intervention using a pen-and-paper cognitive test (TMT-B) compared to the comparator.

  Baseline Visit (Day 0)-one day before intervention, and End Visit (Day 29)-one day after intervention.

Secondary Outcomes (20)

• Composite score of cognitive function

  Baseline Visit (Day 0)-one day before intervention, and End Visit (Day 29)-one day after intervention.

• Cognitive function individual tasks (alphabetic working memory)

  Baseline Visit (Day 0)-one day before intervention, and End Visit (Day 29)-one day after intervention.

• Cognitive function individual task (serial subtraction)

  Baseline Visit (Day 0)-one day before intervention, and End Visit (Day 29)-one day after intervention.

• Cognitive function individual task (stroop)

  Baseline Visit (Day 0)-one day before intervention, and End Visit (Day 29)-one day after intervention.

• Cognitive function individual task (peg and ball)

  Baseline Visit (Day 0)-one day before intervention, and End Visit (Day 29)-one day after intervention.

Study Arms (2)

Dietary nitrate plus caloric restriction

EXPERIMENTAL

Participants will drink beetroot juice with a calorie-restricted diet for 28 days.

Other: Nitrate-rich beetroot juice plus calorie-restricted diet

Dietary nitrate alone

ACTIVE COMPARATOR

Participants will drink beetroot juice with a weight-maintenance diet for 28 days.

Other: Nitrate-rich beetroot juice plus weight-maintenance diet

Interventions

Nitrate-rich beetroot juice plus calorie-restricted diet OTHER

One daily bottle (70ml) of nitrate-rich beetroot juice with a calorie-restricted diet (1,000kcal deficit).

Dietary nitrate plus caloric restriction

Nitrate-rich beetroot juice plus weight-maintenance diet OTHER

One daily bottle (70ml) of nitrate-rich beetroot juice with a weight-maintenance diet (energy will be met).

Dietary nitrate alone

Eligibility Criteria

• Age: 60 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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.
• BMI between 25 and 40 kg/m2.

You may not qualify 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 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).

Sponsors & Collaborators

• Moira Taylor: lead
• King Abdulaziz University: collaborator

Study Sites (1)

The University of Nottingham

Nottingham, Nottinghamshire, NG7 2RD, United Kingdom

RECRUITING

Related Publications (7)

• Alharbi M, Stephan BC, Shannon OM, Siervo M. Does dietary nitrate boost the effects of caloric restriction on brain health? Potential physiological mechanisms and implications for future research. Nutr Metab (Lond). 2023 Oct 25;20(1):45. doi: 10.1186/s12986-023-00766-9.

  PMID: 37880786 BACKGROUND

• Alharbi M, Chiurazzi M, Nasti G, Muscariello E, Mastantuono T, Koechl C, Stephan BC, Shannon OM, Colantuoni A, Siervo M. Caloric Restriction (CR) Plus High-Nitrate Beetroot Juice Does Not Amplify CR-Induced Metabolic Adaptation and Improves Vascular and Cognitive Functions in Overweight Adults: A 14-Day Pilot Randomised Trial. Nutrients. 2023 Feb 10;15(4):890. doi: 10.3390/nu15040890.

  PMID: 36839248 BACKGROUND

• Babateen AM, Shannon OM, O'Brien GM, Olgacer D, Koehl C, Fostier W, Mathers JC, Siervo M. Moderate doses of dietary nitrate elicit greater effects on blood pressure and endothelial function than a high dose: A 13-week pilot study. Nutr Metab Cardiovasc Dis. 2023 Jun;33(6):1263-1267. doi: 10.1016/j.numecd.2023.02.024. Epub 2023 Mar 2.

  PMID: 36958967 BACKGROUND

• Shannon OM, Gregory S, Siervo M. Dietary nitrate, aging and brain health: the latest evidence. Curr Opin Clin Nutr Metab Care. 2022 Nov 1;25(6):393-400. doi: 10.1097/MCO.0000000000000866. Epub 2022 Aug 9.

  PMID: 35943128 BACKGROUND

• Siervo M, Babateen A, Alharbi M, Stephan B, Shannon O. Dietary nitrate and brain health. Too much ado about nothing or a solution for dementia prevention? Br J Nutr. 2022 Sep 28;128(6):1130-1136. doi: 10.1017/S0007114522002434.

  PMID: 36688430 BACKGROUND

• Babateen AM, Shannon OM, O'Brien GM, Okello E, Smith E, Olgacer D, Koehl C, Fostier W, Wightman E, Kennedy D, Mathers JC, Siervo M. Incremental Doses of Nitrate-Rich Beetroot Juice Do Not Modify Cognitive Function and Cerebral Blood Flow in Overweight and Obese Older Adults: A 13-Week Pilot Randomised Clinical Trial. Nutrients. 2022 Mar 2;14(5):1052. doi: 10.3390/nu14051052.

  PMID: 35268027 BACKGROUND

• Siervo M, Arnold R, Wells JC, Tagliabue A, Colantuoni A, Albanese E, Brayne C, Stephan BC. Intentional weight loss in overweight and obese individuals and cognitive function: a systematic review and meta-analysis. Obes Rev. 2011 Nov;12(11):968-83. doi: 10.1111/j.1467-789X.2011.00903.x. Epub 2011 Jul 18.

  PMID: 21762426 BACKGROUND

MeSH Terms

Conditions

Overweight; Obesity

Interventions

Caloric Restriction

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diet Therapy; Nutrition Therapy; Therapeutics; Energy Intake; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Moira A Taylor, PhD RD

  University of Nottingham

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Moira A Taylor, PhD RD

CONTACT

+44 (0)115 823 0141; Moira.Taylor@nottingham.ac.uk

Mushari Alharbi, MBBS, MSc

CONTACT

+44 (0)115 823 0141; Mushari.Alharbi@nottingham.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Whilst participants will not be actively told which arm they have been allocated to, they are likely to be aware that their energy requirement has not been met if they have been allocated to the calorie restricted group.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Model Details: Pilot, randomised, parallel trial

Study Record Dates

• First Submitted: November 6, 2023
• First Posted: November 30, 2023
• Study Start: May 6, 2024
• Primary Completion: September 1, 2025
• Study Completion: September 1, 2025
• Last Updated: December 24, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: When requested.
• Access Criteria: On receipt of requests, data will be made accessible if agreed by the University of Nottingham.

Locations

GB (1)