Ketogenic DietNCT05291767

High Fat Meal and Postprandial TG Levels With and Without Exercise Intervention

A study testing Diet and Exercise in people with Ketogenic Diet and Exercise, run by University of Virginia at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 to 45 yearsHealthy volunteers can take part
Conditions the study is for: Ketogenic Diet, Exercise
What is being tested?: Diet and Exercise
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 7 participants
Where: 1 siteUnited States
Study dates: 28 Mar 2022to 1 Nov 2022
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 45 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Male or female
18-45 years old

Who cannot join

Food allergies (dairy, nuts, food dyes)
Orthopedic or musculoskeletal contraindications to exercise
Known cardiovascular, pulmonary, or metabolic disease
Metal implants that may interfere with bioelectrical impedance analysis
Answers "yes" to one or more questions on the Physical Activity Readiness Questionnaire
Current smoker

Show all 9Show fewer

Blood pressure of 130/80 or higher
Meets or exceeds American College of Sports Medicine guidelines of engaging in 150min/wk of moderate intensity exercise or 75min/wk vigorous intensity exercise Unwilling or unable to follow all aspects of the study protocol
Female participants will have to confirm that they have a normal menstrual cycle (10-12 periods per year). If yes, they are only to participate during the follicular phase of the menstrual cycle (i.e., the week following the first day of menses).

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Virginia
Charlottesville, Virginia, 22904

Other trials in United States

About this study

Official title: The Effect of Moderate-Intensity Exercise on Postprandial Plasma Triglyceride Levels Following a High Fat Meal

The objective of this study is to investigate whether "real-life" bouts of MIE are effective at attenuating PPTL after a meal (either a keto-type brownie (KETO) or a high carb (CON) meal of pasta and sauce), compared to non-exercise control. The primary outcome of this study is the measured change in PPTL level from baseline (fasting) to 6 hours postprandial on each activity level. We hypothesize that MIE will decrease PPTL in comparison to rest. For our secondary outcomes, we expect greater decrease in blood pressure, blood glucose, and metabolic rates after the MIE exercise bouts. Finally, we expect that KETO will be rated as more satiating.

Read the detailed description

Cardiovascular disease (CVD) is the leading cause of death and disease in the United States with an overall prevalence of about 48% in adults >20 years of age. The Global Burden of Health assessment showed that CVD is largely attributed to dietary risks, followed by high systolic blood pressure (BP), high body mass index (BMI), high total cholesterol and fasting plasma triglycerides (TG), smoking, and inadequate physical activity. Increased plasma TG levels can promote atherosclerosis, atherosclerotic lesions, plaque formation, and heart attack. Consumption of high fat meals (HFM), which are very common in the American diet, likely increase postprandial triglyceride levels (PPTL), in proportion to the fat content of the meal. This is of particular concern because Americans, on average, have ~6 eating occasions throughout the day, thus maintaining a postprandial state of chronically high PPTL.

Additionally, a HFM has also been shown to negatively affect endothelial function, blood pressure, glycemic control, and resting metabolic rate. The decline in endothelial function is thought to be mediated by the oxidative stress caused by the elevated PPTL, which then contributes to proatherogenic state. Glycemic control was also found to be disrupted following consumption of a high fat meal likely due to a change in glucose absorption from the gut, glucose production in the liver, or glucose uptake from skeletal muscle. Conversely, blood pressure does not seem to be significantly affected by a high fat meal when measured up to 4 hours postprandial, although these findings are equivocal.

Recent studies have elucidated a potential role of exercise in attenuating the postprandial lipemia response via several proposed mechanisms including exercise-induced increase in fat oxidation, lipoprotein lipase (LPL) messenger ribonucleic acid (mRNA expression) and LPL activity, reduced hepatic VLDL secretions, and the creation of an energy deficit. LPL is responsible for breaking TGs down into free fatty acids, thus improving TG clearance rates. Exercise has also been shown to attenuate the increase in blood pressure and blood glucose caused by the high fat meal.

Previous studies have found that compared to a non-exercising control, moderate-intensity exercise (MIE) decreases PPTL by about 15.5% (p = 0.03) when performed prior to a HFM likely due to the increase in postprandial fat oxidation rate elicited by the exercise. Following exercise performed post-HFM, PPTL attenuation is believed to be due to a decrease in hepatic very low-density lipoprotein (VLDL) secretion, as studies have shown that hepatic VLDL concentrations decrease about 4.5 hours after exercising under post-absorptive conditions and circulating triglyceride (TG) levels of VLDL decrease by 30%. With the decrease in TG secretion, there is an increase in LPL activity that consequently increases TG clearance. Thus, as time between exercise bout and HFM consumption increases, LPL becomes an ever-increasingly important factor that further improves PPTL clearance. However, many studies have only investigated the effects of exercise prior to HFM consumption. Furthermore, many of these studies rely on exaggerated fat intake or energy expenditure in excess of the Physical Activity Guidelines for Americans. While there is one study that measured effects of exercise following a HFM, only moderate intensity (60% VO2peak) was used, and endothelial function was measured up to 4 hours postprandial the test meal and 2 hours following the exercise. However, the PPTL attenuation depends on the type of exercise, energy expenditure, intensity, energy balance, and timing relative to the HFM. Moderate intensity exercise (MIE), which is categorized as 65-75% of maximal heart rate, leads to an increase in glucose oxidation rates, which can potentially lead to a greater increase in fat oxidation in comparison to rest (no exercise) after a meal. While activity guidelines recommend engaging in either moderate or high intensity exercise, it remains unclear whether MIE changes PPTL differently after an HFM.

This is a repeated measures cross-over design, in which all subjects will undergo rest (control) and two exercise protocols. The order of the exercise will be randomized using a traditional coin flip where each combination of flips results in a what meal/ exercise type the subject would be participating in that day. We will have an independent individual (not involved in the study) perform the study randomization and maintain the allocation schedule. Due to the nature of the exercise, blinding participants to the exercise intensity is not possible.

Conditions: Ketogenic Diet, Exercise
Being tested: Diet, Exercise
Medical subject headings: Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

DietOther
Also called High fat meal
participants will consume a high fat (intervention) or high carbohydrate (control) meal.
ExerciseBehavioural
Also called Moderate intensity exercise bout
participants will exercise with medium intensity under supervision for 30 minutes (intervention) or rest (control) after consuming the meal.

Study groups in NCT05291767
Study group	Role	What they receive
Diet: high fat meal	Experimental	Participants will consume either a high fat or a high carbohydrate meal. Receives: Other: Diet
Exercise: medium intensity exercise	Experimental	After consuming the meal, participants will either exercise at moderate intensity for 30 minutes or rest. Receives: Behavioral: Exercise

What is being measured

The primary outcome is the main question the study is designed to answer.

Total Blood triglyceride levels as indicated by fasting triglycerides
The participant's hand will be turned upward and massaged to increase blood flow. After sanitizing, their index finger will be held in an upward position, and the lancet is placed firmly into the fingertip. The first drop of blood will be discarded. The next drop of blood, from the same fingerstick, will be placed in the device to read triglyceride levels.
Measured: Baseline
Total Blood triglyceride levels as indicated by postprandial triglycerides
The participant's hand will be turned upward and massaged to increase blood flow. After sanitizing, their index finger will be held in an upward position, and the lancet is placed firmly into the fingertip. The first drop of blood will be discarded. The next drop of blood, from the same fingerstick, will be placed in the device to read triglyceride levels.
Measured: 2 hours postprandial
Total Blood triglyceride levels as indicated by postprandial triglycerides
The participant's hand will be turned upward and massaged to increase blood flow. After sanitizing, their index finger will be held in an upward position, and the lancet is placed firmly into the fingertip. The first drop of blood will be discarded. The next drop of blood, from the same fingerstick, will be placed in the device to read triglyceride levels.
Measured: 4 hours postprandial
Total Blood triglyceride levels as indicated by postprandial triglycerides
The participant's hand will be turned upward and massaged to increase blood flow. After sanitizing, their index finger will be held in an upward position, and the lancet is placed firmly into the fingertip. The first drop of blood will be discarded. The next drop of blood, from the same fingerstick, will be placed in the device to read triglyceride levels.
Measured: 5 hours postprandial
Total Blood triglyceride levels as indicated by postprandial triglycerides
The participant's hand will be turned upward and massaged to increase blood flow. After sanitizing, their index finger will be held in an upward position, and the lancet is placed firmly into the fingertip. The first drop of blood will be discarded. The next drop of blood, from the same fingerstick, will be placed in the device to read triglyceride levels.
Measured: 6 hours postprandial

Secondary outcomes (18)

Blood glucose level as indicated by fasting blood glucose
Blood glucose will be measured using the device for finger prick blood sampling after arriving in the lab and hourly after consuming the meal.
Measured: Baseline
Finger prick blood sample for blood glucose level as indicated by postprandial blood glucose
Blood glucose will be measured using the device for finger prick blood sampling after arriving in the lab and hourly after consuming the meal.
Measured: 2 hours postprandial
Finger prick blood sample for blood glucose level as indicated by postprandial blood glucose
Blood glucose will be measured using the device for finger prick blood sampling after arriving in the lab and hourly after consuming the meal.
Measured: 4 hours postprandial
Finger prick blood sample for blood glucose level as indicated by postprandial blood glucose
Blood glucose will be measured using the device for finger prick blood sampling after arriving in the lab and hourly after consuming the meal.
Measured: 5 hours postprandial
Finger prick blood sample for blood glucose level as indicated by postprandial blood glucose
Blood glucose will be measured using the device for finger prick blood sampling after arriving in the lab and hourly after consuming the meal.
Measured: 6 hours postprandial
Systolic and diastolic Blood pressure
A Bluetooth blood pressure cuff will also be given to the participant that they will wear continuously throughout the visit; data from the device will be taken at the end of the visit for 15-minute intervals.
Measured: Baseline to 6 hours postprandial in 15 minute increments
Indirect Calorimetry: Resting Metabolic Rate
Participant will lay at rest for 15 minutes prior to starting the test. A metabolic mask will then be placed over their mouth to analyze their oxygen and carbon dioxide usage to estimate their resting metabolic rate and respiratory exchange ratio. This will take about 30 minutes.
Measured: Baseline
Indirect Calorimetry: Resting Metabolic Rate
Participant will lay at rest for 15 minutes prior to starting the test. A metabolic mask will then be placed over their mouth to analyze their oxygen and carbon dioxide usage to estimate their resting metabolic rate and respiratory exchange ratio. This will take about 30 minutes.
Measured: 2 hour postprandial
Indirect Calorimetry: Resting Metabolic Rate
Participant will lay at rest for 15 minutes prior to starting the test. A metabolic mask will then be placed over their mouth to analyze their oxygen and carbon dioxide usage to estimate their resting metabolic rate and respiratory exchange ratio. This will take about 30 minutes.
Measured: 3 hour postprandial
Indirect Calorimetry: Resting Metabolic Rate
Participant will lay at rest for 15 minutes prior to starting the test. A metabolic mask will then be placed over their mouth to analyze their oxygen and carbon dioxide usage to estimate their resting metabolic rate and respiratory exchange ratio. This will take about 30 minutes.
Measured: 4 hour postprandial
Indirect Calorimetry: Resting Metabolic Rate
Participant will lay at rest for 15 minutes prior to starting the test. A metabolic mask will then be placed over their mouth to analyze their oxygen and carbon dioxide usage to estimate their resting metabolic rate and respiratory exchange ratio. This will take about 30 minutes.
Measured: 5 hour postprandial
Indirect Calorimetry: Resting Metabolic Rate
Participant will lay at rest for 15 minutes prior to starting the test. A metabolic mask will then be placed over their mouth to analyze their oxygen and carbon dioxide usage to estimate their resting metabolic rate and respiratory exchange ratio. This will take about 30 minutes.
Measured: 6 hour postprandial
Indirect Calorimetry: Respiratory Exchange Ratio
Participant will lay at rest for 15 minutes prior to starting the test. A metabolic mask will then be placed over their mouth to analyze their oxygen and carbon dioxide usage to estimate their resting metabolic rate and respiratory exchange ratio. This will take about 30 minutes.
Measured: Baseline
Indirect Calorimetry: Respiratory Exchange Ratio
Participant will lay at rest for 15 minutes prior to starting the test. A metabolic mask will then be placed over their mouth to analyze their oxygen and carbon dioxide usage to estimate their resting metabolic rate and respiratory exchange ratio. This will take about 30 minutes.
Measured: 2 hours postprandial
Indirect Calorimetry: Respiratory Exchange Ratio
Participant will lay at rest for 15 minutes prior to starting the test. A metabolic mask will then be placed over their mouth to analyze their oxygen and carbon dioxide usage to estimate their resting metabolic rate and respiratory exchange ratio. This will take about 30 minutes.
Measured: 3 hours postprandial
Indirect Calorimetry: Respiratory Exchange Ratio
Participant will lay at rest for 15 minutes prior to starting the test. A metabolic mask will then be placed over their mouth to analyze their oxygen and carbon dioxide usage to estimate their resting metabolic rate and respiratory exchange ratio. This will take about 30 minutes.
Measured: 4 hours postprandial
Indirect Calorimetry: Respiratory Exchange Ratio
Participant will lay at rest for 15 minutes prior to starting the test. A metabolic mask will then be placed over their mouth to analyze their oxygen and carbon dioxide usage to estimate their resting metabolic rate and respiratory exchange ratio. This will take about 30 minutes.
Measured: 5 hours postprandial
Indirect Calorimetry: Respiratory Exchange Ratio
Participant will lay at rest for 15 minutes prior to starting the test. A metabolic mask will then be placed over their mouth to analyze their oxygen and carbon dioxide usage to estimate their resting metabolic rate and respiratory exchange ratio. This will take about 30 minutes.
Measured: 6 hours postprandial

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

28 Mar 20221 Nov 2022

First posted23 Mar 2022
Study start28 Mar 2022
Primary completion1 Nov 2022
Study completion1 Nov 2022

Why it stopped: Personnel and funding issues

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (21)Papers the sponsor has linked to this study.
Other trials for Ketogenic DietStudies of the same condition, open and under way.
More trials run by University of VirginiaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 7 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05291767
Sponsor's protocol ID: HSR210163
Status last verified: Jan 2023
First submitted: 3 Mar 2022
Last updated: 31 Jan 2023
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Global Burden of Cardiovascular Diseases Collaboration; Roth GA, Johnson CO, Abate KH, Abd-Allah F, Ahmed M, Alam K, Alam T, Alvis-Guzman N, Ansari H, Arnlov J, Atey TM, Awasthi A, Awoke T, Barac A, Barnighausen T, Bedi N, Bennett D, Bensenor I, Biadgilign S, Castaneda-Orjuela C, Catala-Lopez F, Davletov K, Dharmaratne S, Ding EL, Dubey M, Faraon EJA, Farid T, Farvid MS, Feigin V, Fernandes J, Frostad J, Gebru A, Geleijnse JM, Gona PN, Griswold M, Hailu GB, Hankey GJ, Hassen HY, Havmoeller R, Hay S, Heckbert SR, Irvine CMS, James SL, Jara D, Kasaeian A, Khan AR, Khera S, Khoja AT, Khubchandani J, Kim D, Kolte D, Lal D, Larsson A, Linn S, Lotufo PA, Magdy Abd El Razek H, Mazidi M, Meier T, Mendoza W, Mensah GA, Meretoja A, Mezgebe HB, Mirrakhimov E, Mohammed S, Moran AE, Nguyen G, Nguyen M, Ong KL, Owolabi M, Pletcher M, Pourmalek F, Purcell CA, Qorbani M, Rahman M, Rai RK, Ram U, Reitsma MB, Renzaho AMN, Rios-Blancas MJ, Safiri S, Salomon JA, Sartorius B, Sepanlou SG, Shaikh MA, Silva D, Stranges S, Tabares-Seisdedos R, Tadele Atnafu N, Thakur JS, Topor-Madry R, Truelsen T, Tuzcu EM, Tyrovolas S, Ukwaja KN, Vasankari T, Vlassov V, Vollset SE, Wakayo T, Weintraub R, Wolfe C, Workicho A, Xu G, Yadgir S, Yano Y, Yip P, Yonemoto N, Younis M, Yu C, Zaidi Z, Zaki MES, Zipkin B, Afshin A, Gakidou E, Lim SS, Mokdad AH, Naghavi M, Vos T, Murray CJL. The Burden of Cardiovascular Diseases Among US States, 1990-2016. JAMA Cardiol. 2018 May 1;3(5):375-389. doi: 10.1001/jamacardio.2018.0385.
PubMed 29641820
DeSalvo KB, Olson R, Casavale KO. Dietary Guidelines for Americans. JAMA. 2016 Feb 2;315(5):457-8. doi: 10.1001/jama.2015.18396. No abstract available.
PubMed 26746707
Torres N, Guevara-Cruz M, Velazquez-Villegas LA, Tovar AR. Nutrition and Atherosclerosis. Arch Med Res. 2015 Jul;46(5):408-26. doi: 10.1016/j.arcmed.2015.05.010. Epub 2015 May 29.
PubMed 26031780
Patsch JR, Karlin JB, Scott LW, Smith LC, Gotto AM Jr. Inverse relationship between blood levels of high density lipoprotein subfraction 2 and magnitude of postprandial lipemia. Proc Natl Acad Sci U S A. 1983 Mar;80(5):1449-53. doi: 10.1073/pnas.80.5.1449.
PubMed 6402780
Nordestgaard BG, Benn M, Schnohr P, Tybjaerg-Hansen A. Nonfasting triglycerides and risk of myocardial infarction, ischemic heart disease, and death in men and women. JAMA. 2007 Jul 18;298(3):299-308. doi: 10.1001/jama.298.3.299.
PubMed 17635890
Cohn JS, McNamara JR, Cohn SD, Ordovas JM, Schaefer EJ. Postprandial plasma lipoprotein changes in human subjects of different ages. J Lipid Res. 1988 Apr;29(4):469-79.
PubMed 3392464
Bae JH, Bassenge E, Kim KB, Kim YN, Kim KS, Lee HJ, Moon KC, Lee MS, Park KY, Schwemmer M. Postprandial hypertriglyceridemia impairs endothelial function by enhanced oxidant stress. Atherosclerosis. 2001 Apr;155(2):517-23. doi: 10.1016/s0021-9150(00)00601-8.
PubMed 11254924
Hennig B, Toborek M, McClain CJ. High-energy diets, fatty acids and endothelial cell function: implications for atherosclerosis. J Am Coll Nutr. 2001 Apr;20(2 Suppl):97-105. doi: 10.1080/07315724.2001.10719021.
PubMed 11349944
Parry SA, Smith JR, Corbett TR, Woods RM, Hulston CJ. Short-term, high-fat overfeeding impairs glycaemic control but does not alter gut hormone responses to a mixed meal tolerance test in healthy, normal-weight individuals. Br J Nutr. 2017 Jan;117(1):48-55. doi: 10.1017/S0007114516004475. Epub 2017 Jan 24.
PubMed 28115026
Richter CK, Skulas-Ray AC, Gaugler TL, Lambert JD, Proctor DN, Kris-Etherton PM. Incorporating freeze-dried strawberry powder into a high-fat meal does not alter postprandial vascular function or blood markers of cardiovascular disease risk: a randomized controlled trial. Am J Clin Nutr. 2017 Feb;105(2):313-322. doi: 10.3945/ajcn.116.141804. Epub 2016 Dec 21.
PubMed 28003205
Bui C, Petrofsky J, Berk L, Shavlik D, Remigio W, Montgomery S. Acute effect of a single high-fat meal on forearm blood flow, blood pressure and heart rate in healthy male Asians and Caucasians: a pilot study. Southeast Asian J Trop Med Public Health. 2010 Mar;41(2):490-500.
PubMed 20578534
Heseltine D, Potter JF, Hartley G, Macdonald IA, James OF. Blood pressure, heart rate and neuroendocrine responses to a high carbohydrate and a high fat meal in healthy young subjects. Clin Sci (Lond). 1990 Nov;79(5):517-22. doi: 10.1042/cs0790517.
PubMed 2174321
Jakulj F, Zernicke K, Bacon SL, van Wielingen LE, Key BL, West SG, Campbell TS. A high-fat meal increases cardiovascular reactivity to psychological stress in healthy young adults. J Nutr. 2007 Apr;137(4):935-9. doi: 10.1093/jn/137.4.935.
PubMed 17374657
Freese EC, Gist NH, Cureton KJ. Effect of prior exercise on postprandial lipemia: an updated quantitative review. J Appl Physiol (1985). 2014 Jan 1;116(1):67-75. doi: 10.1152/japplphysiol.00623.2013. Epub 2013 Nov 7.
PubMed 24201708
Trombold JR, Christmas KM, Machin DR, Kim IY, Coyle EF. Acute high-intensity endurance exercise is more effective than moderate-intensity exercise for attenuation of postprandial triglyceride elevation. J Appl Physiol (1985). 2013 Mar 15;114(6):792-800. doi: 10.1152/japplphysiol.01028.2012. Epub 2013 Jan 31.
PubMed 23372145

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruiting
Ketone Ester for Treatment Of Acute Heart Failure
Acute Heart Failure
Active, not recruiting
Effects of Short-term Adaptation to Ketogenic Diet on Endurance Trained Athletes
Ketogenic Diet, Control Condition
Recruiting
Well-Formulated Ketogenic Diet Polycystic Kidney Disease
Polycystic Kidney Disease
Not yet recruiting
GLAD-KE GLioma Biomarker and Safety Assessment During Dietary Ketone Elevation Subtitle: A Surgical Biomarker Discovery Study of Ketogenic Therapy in Recurrent Glioma
Recurrent Glioma (Glioblastoma Multiforme)
Recruiting
Ketogenic Diet and Neuromodulation in Treatment Resistant Depression
Major Depressive Disorder (MDD), Treatment Resistant Depression (TRD)

All Ketogenic Diet trials

Study at a glance

From the registry record, last updated by the sponsor on 31 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Effect of Moderate-Intensity Exercise on Postprandial Plasma Triglyceride Levels Following a High Fat Meal
ClinicalTrials.gov ID: NCT05291767
Acronym / sponsor ID: HSR210163
Conditions: Ketogenic Diet, Exercise
Study type: Interventional
Recruitment status: TerminatedReason stopped: Personnel and funding issues
Enrolment: 7 participants (actual)
Lead sponsor: University of VirginiaUniversity, hospital or other
Study start: 28 Mar 2022 (actual)
Primary completion: 1 Nov 2022 (actual)
Study completion: 1 Nov 2022 (actual)
First posted: 23 Mar 2022 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Diet: high fat meal	Experimental	Other: DietParticipants will consume either a high fat or a high carbohydrate meal.
Exercise: medium intensity exercise	Experimental	Behavioral: ExerciseAfter consuming the meal, participants will either exercise at moderate intensity for 30 minutes or rest.

Who may qualify

Ages: 18 to 45 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (2 listed)

Male or female
18-45 years old

Key exclusion criteria (9 listed)

Food allergies (dairy, nuts, food dyes)
Orthopedic or musculoskeletal contraindications to exercise
Known cardiovascular, pulmonary, or metabolic disease
Metal implants that may interfere with bioelectrical impedance analysis
Answers "yes" to one or more questions on the Physical Activity Readiness Questionnaire

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
DietAlso: High fat mealparticipants will consume a high fat (intervention) or high carbohydrate (control) meal.	Other	Diet: high fat meal
ExerciseAlso: Moderate intensity exercise boutparticipants will exercise with medium intensity under supervision for 30 minutes (intervention) or rest (control) after consuming the meal.	Behavioural	Exercise: medium intensity exercise

Primary outcome

Total Blood triglyceride levels as indicated by fasting triglycerides
Time frame: Baseline
The participant's hand will be turned upward and massaged to increase blood flow. After sanitizing, their index finger will be held in an upward position, and the lancet is placed firmly into the fingertip. The first drop of blood will be discarded. The next drop of blood, from the same fingerstick, will be placed in the device to read triglyceride levels.
Total Blood triglyceride levels as indicated by postprandial triglycerides
Time frame: 2 hours postprandial
The participant's hand will be turned upward and massaged to increase blood flow. After sanitizing, their index finger will be held in an upward position, and the lancet is placed firmly into the fingertip. The first drop of blood will be discarded. The next drop of blood, from the same fingerstick, will be placed in the device to read triglyceride levels.
Total Blood triglyceride levels as indicated by postprandial triglycerides
Time frame: 4 hours postprandial
The participant's hand will be turned upward and massaged to increase blood flow. After sanitizing, their index finger will be held in an upward position, and the lancet is placed firmly into the fingertip. The first drop of blood will be discarded. The next drop of blood, from the same fingerstick, will be placed in the device to read triglyceride levels.
Total Blood triglyceride levels as indicated by postprandial triglycerides
Time frame: 5 hours postprandial
The participant's hand will be turned upward and massaged to increase blood flow. After sanitizing, their index finger will be held in an upward position, and the lancet is placed firmly into the fingertip. The first drop of blood will be discarded. The next drop of blood, from the same fingerstick, will be placed in the device to read triglyceride levels.
Total Blood triglyceride levels as indicated by postprandial triglycerides
Time frame: 6 hours postprandial
The participant's hand will be turned upward and massaged to increase blood flow. After sanitizing, their index finger will be held in an upward position, and the lancet is placed firmly into the fingertip. The first drop of blood will be discarded. The next drop of blood, from the same fingerstick, will be placed in the device to read triglyceride levels.

18 secondary outcomes

Blood glucose level as indicated by fasting blood glucose
Time frame: Baseline
Finger prick blood sample for blood glucose level as indicated by postprandial blood glucose
Time frame: 2 hours postprandial
Finger prick blood sample for blood glucose level as indicated by postprandial blood glucose
Time frame: 4 hours postprandial
Finger prick blood sample for blood glucose level as indicated by postprandial blood glucose
Time frame: 5 hours postprandial
Finger prick blood sample for blood glucose level as indicated by postprandial blood glucose
Time frame: 6 hours postprandial
Systolic and diastolic Blood pressure
Time frame: Baseline to 6 hours postprandial in 15 minute increments
Indirect Calorimetry: Resting Metabolic Rate
Time frame: Baseline
Indirect Calorimetry: Resting Metabolic Rate
Time frame: 2 hour postprandial
Indirect Calorimetry: Resting Metabolic Rate
Time frame: 3 hour postprandial
Indirect Calorimetry: Resting Metabolic Rate
Time frame: 4 hour postprandial
Indirect Calorimetry: Resting Metabolic Rate
Time frame: 5 hour postprandial
Indirect Calorimetry: Resting Metabolic Rate
Time frame: 6 hour postprandial
Indirect Calorimetry: Respiratory Exchange Ratio
Time frame: Baseline
Indirect Calorimetry: Respiratory Exchange Ratio
Time frame: 2 hours postprandial
Indirect Calorimetry: Respiratory Exchange Ratio
Time frame: 3 hours postprandial
Indirect Calorimetry: Respiratory Exchange Ratio
Time frame: 4 hours postprandial
Indirect Calorimetry: Respiratory Exchange Ratio
Time frame: 5 hours postprandial
Indirect Calorimetry: Respiratory Exchange Ratio
Time frame: 6 hours postprandial

Results and safety

The study was stopped early (reason given: Personnel and funding issues). Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2023.
Background: PubMed 29641820Global Burden of Cardiovascular Diseases Collaboration; Roth GA, Johnson CO, Abate KH, Abd-Allah F, Ahmed M, Alam K, Alam T, Alvis-Guzman N, Ansari H, Arnlov J, Atey TM, Awasthi A, Awoke T, Barac A, Barnighausen T, Bedi N, Bennett D, Bensenor I, Biadgilign S, Castaneda-Orjuela C, Catala-Lopez F, Davletov K, Dharmaratne S, Ding EL, Dubey M, Faraon EJA, Farid T, Farvid MS, Feigin V, Fernandes J, Frostad J, Gebru A, Geleijnse JM, Gona PN, Griswold M, Hailu GB, Hankey GJ, Hassen HY, Havmoeller R, Hay S, Heckbert SR, Irvine CMS, James SL, Jara D, Kasaeian A, Khan AR, Khera S, Khoja AT, Khubchandani J, Kim D, Kolte D, Lal D, Larsson A, Linn S, Lotufo PA, Magdy Abd El Razek H, Mazidi M, Meier T, Mendoza W, Mensah GA, Meretoja A, Mezgebe HB, Mirrakhimov E, Mohammed S, Moran AE, Nguyen G, Nguyen M, Ong KL, Owolabi M, Pletcher M, Pourmalek F, Purcell CA, Qorbani M, Rahman M, Rai RK, Ram U, Reitsma MB, Renzaho AMN, Rios-Blancas MJ, Safiri S, Salomon JA, Sartorius B, Sepanlou SG, Shaikh MA, Silva D, Stranges S, Tabares-Seisdedos R, Tadele Atnafu N, Thakur JS, Topor-Madry R, Truelsen T, Tuzcu EM, Tyrovolas S, Ukwaja KN, Vasankari T, Vlassov V, Vollset SE, Wakayo T, Weintraub R, Wolfe C, Workicho A, Xu G, Yadgir S, Yano Y, Yip P, Yonemoto N, Younis M, Yu C, Zaidi Z, Zaki MES, Zipkin B, Afshin A, Gakidou E, Lim SS, Mokdad AH, Naghavi M, Vos T, Murray CJL. The Burden of Cardiovascular Diseases Among US States, 1990-2016. JAMA Cardiol. 2018 May 1;3(5):375-389. doi: 10.1001/jamacardio.2018.0385.
Background: PubMed 26746707DeSalvo KB, Olson R, Casavale KO. Dietary Guidelines for Americans. JAMA. 2016 Feb 2;315(5):457-8. doi: 10.1001/jama.2015.18396. No abstract available.
Background: PubMed 26031780Torres N, Guevara-Cruz M, Velazquez-Villegas LA, Tovar AR. Nutrition and Atherosclerosis. Arch Med Res. 2015 Jul;46(5):408-26. doi: 10.1016/j.arcmed.2015.05.010. Epub 2015 May 29.
Background: PubMed 6402780Patsch JR, Karlin JB, Scott LW, Smith LC, Gotto AM Jr. Inverse relationship between blood levels of high density lipoprotein subfraction 2 and magnitude of postprandial lipemia. Proc Natl Acad Sci U S A. 1983 Mar;80(5):1449-53. doi: 10.1073/pnas.80.5.1449.
Background: PubMed 17635890Nordestgaard BG, Benn M, Schnohr P, Tybjaerg-Hansen A. Nonfasting triglycerides and risk of myocardial infarction, ischemic heart disease, and death in men and women. JAMA. 2007 Jul 18;298(3):299-308. doi: 10.1001/jama.298.3.299.
Background: PubMed 3392464Cohn JS, McNamara JR, Cohn SD, Ordovas JM, Schaefer EJ. Postprandial plasma lipoprotein changes in human subjects of different ages. J Lipid Res. 1988 Apr;29(4):469-79.
Background: PubMed 11254924Bae JH, Bassenge E, Kim KB, Kim YN, Kim KS, Lee HJ, Moon KC, Lee MS, Park KY, Schwemmer M. Postprandial hypertriglyceridemia impairs endothelial function by enhanced oxidant stress. Atherosclerosis. 2001 Apr;155(2):517-23. doi: 10.1016/s0021-9150(00)00601-8.
Background: PubMed 11349944Hennig B, Toborek M, McClain CJ. High-energy diets, fatty acids and endothelial cell function: implications for atherosclerosis. J Am Coll Nutr. 2001 Apr;20(2 Suppl):97-105. doi: 10.1080/07315724.2001.10719021.
Background: PubMed 28115026Parry SA, Smith JR, Corbett TR, Woods RM, Hulston CJ. Short-term, high-fat overfeeding impairs glycaemic control but does not alter gut hormone responses to a mixed meal tolerance test in healthy, normal-weight individuals. Br J Nutr. 2017 Jan;117(1):48-55. doi: 10.1017/S0007114516004475. Epub 2017 Jan 24.
Background: PubMed 28003205Richter CK, Skulas-Ray AC, Gaugler TL, Lambert JD, Proctor DN, Kris-Etherton PM. Incorporating freeze-dried strawberry powder into a high-fat meal does not alter postprandial vascular function or blood markers of cardiovascular disease risk: a randomized controlled trial. Am J Clin Nutr. 2017 Feb;105(2):313-322. doi: 10.3945/ajcn.116.141804. Epub 2016 Dec 21.
Background: PubMed 20578534Bui C, Petrofsky J, Berk L, Shavlik D, Remigio W, Montgomery S. Acute effect of a single high-fat meal on forearm blood flow, blood pressure and heart rate in healthy male Asians and Caucasians: a pilot study. Southeast Asian J Trop Med Public Health. 2010 Mar;41(2):490-500.
Background: PubMed 2174321Heseltine D, Potter JF, Hartley G, Macdonald IA, James OF. Blood pressure, heart rate and neuroendocrine responses to a high carbohydrate and a high fat meal in healthy young subjects. Clin Sci (Lond). 1990 Nov;79(5):517-22. doi: 10.1042/cs0790517.
Individual participant dataSharing planned: No

Related trials for Ketogenic Diet

Not yet recruiting
Ketone Ester for Treatment Of Acute Heart Failure
Acute Heart Failure
Active, not recruiting
Effects of Short-term Adaptation to Ketogenic Diet on Endurance Trained Athletes
Ketogenic Diet, Control Condition
Recruiting
Well-Formulated Ketogenic Diet Polycystic Kidney Disease
Polycystic Kidney Disease
Not yet recruiting
GLAD-KE GLioma Biomarker and Safety Assessment During Dietary Ketone Elevation Subtitle: A Surgical Biomarker Discovery Study of Ketogenic Therapy in Recurrent Glioma
Recurrent Glioma (Glioblastoma Multiforme)
Recruiting
Ketogenic Diet and Neuromodulation in Treatment Resistant Depression
Major Depressive Disorder (MDD), Treatment Resistant Depression (TRD)

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Diet and Exercise in people with Ketogenic Diet and Exercise, run by University of Virginia at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 31 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: Personnel and funding issues). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Total Blood triglyceride levels as indicated by fasting triglycerides (time frame: Baseline). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05291767, which also lists 21 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2023.