Cardiovascular Diseases Clinical Trial
Official title:
The Effects of Ketone Ester Supplementation on Nocturnal Blood Pressure in Middle-Aged and Older Adults
NCT number | NCT05888506 |
Other study ID # | H23223 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | August 1, 2023 |
Est. completion date | October 3, 2023 |
Verified date | October 2023 |
Source | Georgia Southern University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 40 |
Est. completion date | October 3, 2023 |
Est. primary completion date | October 1, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 50 Years and older |
Eligibility | Inclusion Criteria: - 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 Exclusion Criteria: - Alterations to use of prescription medication within the past 6 months - Allergy to any of the ingredients in the ketone beverage - Communication barriers |
Country | Name | City | State |
---|---|---|---|
United States | Biodynamics and Human Performance Center | Savannah | Georgia |
Lead Sponsor | Collaborator |
---|---|
Georgia Southern University | Auburn University |
United States,
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. — View Citation
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. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Nighttime blood pressure | The investigations will use ambulatory blood pressure monitoring to characterize nighttime blood pressure (mmHg) | Night one of supplement ingestion (i.e., from time asleep to time awake for one night per condition) | |
Secondary | Nighttime heart rate variability | The investigators will use a single-lead electrocardiograph to characterize nocturnal heart rate variability (ms) | Night one of supplement ingestion (i.e., from time asleep to time awake for one night per condition) | |
Secondary | Objective sleep duration | Actigraph accelerometers will be used to quantify sleep duration | Night one of supplement ingestion (i.e., from time asleep to time awake for one night per condition) | |
Secondary | Objective sleep efficiency | Actigraph accelerometers will be used to quantify % of time in bed actually spent sleeping to calculate sleep efficiency | Night one of supplement ingestion (i.e., from time asleep to time awake for one night per condition) | |
Secondary | Subjective sleep quality | A single-item visual analogue sleep scale will be used to quantify subjective sleep quality (i.e., 0 to 100, with a higher score indicating better sleep) | Night one of supplement ingestion (i.e., from time asleep to time awake for one night per condition) | |
Secondary | Subjective sleep quality | The investigators will use the Pittsburgh Sleep Quality Index (PSQI) to assess perceived sleep quality reflective of the one month period leading into the study. PSQI scores range from 0-21, with a higher score indicting worse sleep. | Pre-intervention | |
Secondary | Pulse wave analysis | The investigators will use the SphygmoCor XCEL system to assess pulse wave analysis (PWA) The sampling site is the brachial artery (upper alarm instrumented with a cuff for oscillometric sphygmomanometer). | Pre-intervention | |
Secondary | Pulse wave velocity | The investigators will use the SphygmoCor XCEL system to assess pulse wave velocity (PWV). A high-fidelity strain-gauge transducer is used to obtain the pressure waveform at the carotid pulse. Distances from the carotid artery sampling site to the femoral artery (upper leg instrumented with a thigh cuff for oscillometric sphygmomanometry), and from the carotid artery to the suprasternal notch will be recorded. PWV will be expressed as m/s. | Pre-intervention |
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