Ketone Ester Supplementation and Nocturnal Blood Pressure

NCT05888506 | Completed

• 1 other identifier: H23223
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Cardiovascular disease (CVD) is the number one cause of death globally and high blood pressure (i.e., hypertension) is the leading modifiable risk factor for CVD and all-cause mortality. Advancing age is the primary risk factor for hypertension and CVD. Moreover, compared to younger adults, older adults exhibit reduced nocturnal dipping of blood pressure resulting in elevated nighttime blood pressure values, which are a better predictor of cardiovascular outcomes than daytime blood pressure. Intriguingly, recently published rodent data suggests that ketone supplementation protects against hypertension, blood vessel dysfunction, and kidney injury. Whether ketone supplementation provides vascular health benefits in humans remains to be determined. Therefore, the investigations seek to conduct an acute ketone supplementation study to determine whether ketone supplementation may restore a more healthy nighttime blood pressure phenotype in middle-aged and older adults. The investigations will also determine whether ketone supplementation influences nocturnal heart rate variability, a non-invasive of autonomic function that may be influenced by ketone supplementation in a manner that influences blood pressure.

Conditions

Cardiovascular Diseases in Old Age; Aging; Cardiovascular Diseases; Sleep

Keywords

blood pressure; sleep; heart rate variability; ketone ester

Outcome Measures

Primary Outcomes (1)

• Nocturnal blood pressure dipping

  The investigations will use ambulatory blood pressure monitoring to characterize night-to-day blood pressure ratio

  Night one of supplement ingestion (i.e., from time asleep to time awake for one night per condition)

Secondary Outcomes (8)

• Nighttime blood pressure

  Night one of supplement ingestion (i.e., from time asleep to time awake for one night per condition)

• Nighttime heart rate variability

  Night one of supplement ingestion (i.e., from time asleep to time awake for one night per condition)

• Objective sleep duration

  Night one of supplement ingestion (i.e., from time asleep to time awake for one night per condition)

• Objective sleep efficiency

  Night one of supplement ingestion (i.e., from time asleep to time awake for one night per condition)

• Subjective sleep quality

  Night one of supplement ingestion (i.e., from time asleep to time awake for one night per condition)

Study Arms (2)

Ketone Ester

EXPERIMENTAL

Participants will consume the supplement prior to bedtime. Nocturnal blood pressure, heart rate, and sleep characteristics will be assessed

Dietary Supplement: Ketone Ester

Placebo Supplement

PLACEBO COMPARATOR

Participants will consume the supplement prior to bedtime. Nocturnal blood pressure, heart rate, and sleep characteristics will be assessed

Dietary Supplement: Placebo

Interventions

Ketone Ester DIETARY_SUPPLEMENT

Participants will consume the ketone ester beverage produced by KetoneAid prior to bedtime. Participants will consume 60 mL (30 grams ketones) of the ketone beverage.

Ketone Ester

Placebo DIETARY_SUPPLEMENT

Participants will consume the placebo supplement prior to bedtime. The placebo supplement will be a ketone ester-free, taste and viscosity-matched, beverage produced by KetoneAid.

Placebo Supplement

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Greater than or equal to 50 years of age
• Body mass index (BMI) below 40 kg/m\^2
• No alterations to use of prescription medication within the past 6 months

You may not qualify if:

• Alterations to use of prescription medication within the past 6 months
• Allergy to any of the ingredients in the ketone beverage
• Communication barriers

Sponsors & Collaborators

• Georgia Southern University: lead
• Auburn University: collaborator

Study Sites (1)

Biodynamics and Human Performance Center

Savannah, Georgia, 31419, United States

Location

Related Publications (3)

• Fagard RH, Celis H, Thijs L, Staessen JA, Clement DL, De Buyzere ML, De Bacquer DA. Daytime and nighttime blood pressure as predictors of death and cause-specific cardiovascular events in hypertension. Hypertension. 2008 Jan;51(1):55-61. doi: 10.1161/HYPERTENSIONAHA.107.100727. Epub 2007 Nov 26.

  PMID: 18039980 BACKGROUND

• Valensi P. Autonomic nervous system activity changes in patients with hypertension and overweight: role and therapeutic implications. Cardiovasc Diabetol. 2021 Aug 19;20(1):170. doi: 10.1186/s12933-021-01356-w.

  PMID: 34412646 BACKGROUND

• Chakraborty S, Galla S, Cheng X, Yeo JY, Mell B, Singh V, Yeoh B, Saha P, Mathew AV, Vijay-Kumar M, Joe B. Salt-Responsive Metabolite, beta-Hydroxybutyrate, Attenuates Hypertension. Cell Rep. 2018 Oct 16;25(3):677-689.e4. doi: 10.1016/j.celrep.2018.09.058.

  PMID: 30332647 BACKGROUND

MeSH Terms

Conditions

Cardiovascular Diseases

Interventions

formic acid 4-(3-oxobutyl)phenyl ester

Study Officials

• Gregory J Grosicki, PhD

  Georgia Southern University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 5, 2023
• First Posted: June 5, 2023
• Study Start: August 1, 2023
• Primary Completion: October 1, 2023
• Study Completion: October 3, 2023
• Last Updated: October 6, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)