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

NCT05291767 | Terminated

• 1 other identifier: HSR210163
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Ketogenic Diet; Exercise

Outcome Measures

Primary Outcomes (5)

• 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.

  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.

  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.

  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.

  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.

  6 hours postprandial

Secondary Outcomes (18)

• Blood glucose level as indicated by fasting blood glucose

  Baseline

• Finger prick blood sample for blood glucose level as indicated by postprandial blood glucose

  2 hours postprandial

• Finger prick blood sample for blood glucose level as indicated by postprandial blood glucose

  4 hours postprandial

• Finger prick blood sample for blood glucose level as indicated by postprandial blood glucose

  5 hours postprandial

• Finger prick blood sample for blood glucose level as indicated by postprandial blood glucose

  6 hours postprandial

Study Arms (2)

Diet: high fat meal

EXPERIMENTAL

Participants will consume either a high fat or a high carbohydrate meal.

Other: Diet

Exercise: medium intensity exercise

EXPERIMENTAL

After consuming the meal, participants will either exercise at moderate intensity for 30 minutes or rest.

Behavioral: Exercise

Interventions

Diet OTHER

participants will consume a high fat (intervention) or high carbohydrate (control) meal.

Also known as: High fat meal

Diet: high fat meal

Exercise BEHAVIORAL

participants will exercise with medium intensity under supervision for 30 minutes (intervention) or rest (control) after consuming the meal.

Also known as: Moderate intensity exercise bout

Exercise: medium intensity exercise

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male or female
• years old

You may not qualify if:

• 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
• 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).

Sponsors & Collaborators

• University of Virginia: lead

Study Sites (1)

University of Virginia

Charlottesville, Virginia, 22904, United States

Location

Related Publications (21)

• 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.

  PMID: 29641820 BACKGROUND

• 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.

  PMID: 26746707 BACKGROUND

• 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.

  PMID: 26031780 BACKGROUND

• 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.

  PMID: 6402780 BACKGROUND

• 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.

  PMID: 17635890 BACKGROUND

• 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.

  PMID: 3392464 BACKGROUND

• 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.

  PMID: 11254924 BACKGROUND

• 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.

  PMID: 11349944 BACKGROUND

• 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.

  PMID: 28115026 BACKGROUND

• 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.

  PMID: 28003205 BACKGROUND

• 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.

  PMID: 20578534 BACKGROUND

• 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.

  PMID: 2174321 BACKGROUND

• 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.

  PMID: 17374657 BACKGROUND

• 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.

  PMID: 24201708 BACKGROUND

• 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.

  PMID: 23372145 BACKGROUND

• Currie KD, McKelvie RS, Macdonald MJ. Flow-mediated dilation is acutely improved after high-intensity interval exercise. Med Sci Sports Exerc. 2012 Nov;44(11):2057-64. doi: 10.1249/MSS.0b013e318260ff92.

  PMID: 22648341 BACKGROUND

• Ciolac EG, Bocchi EA, Bortolotto LA, Carvalho VO, Greve JM, Guimaraes GV. Effects of high-intensity aerobic interval training vs. moderate exercise on hemodynamic, metabolic and neuro-humoral abnormalities of young normotensive women at high familial risk for hypertension. Hypertens Res. 2010 Aug;33(8):836-43. doi: 10.1038/hr.2010.72. Epub 2010 May 7.

  PMID: 20448634 BACKGROUND

• Batacan RB Jr, Duncan MJ, Dalbo VJ, Tucker PS, Fenning AS. Effects of high-intensity interval training on cardiometabolic health: a systematic review and meta-analysis of intervention studies. Br J Sports Med. 2017 Mar;51(6):494-503. doi: 10.1136/bjsports-2015-095841. Epub 2016 Oct 20.

  PMID: 27797726 BACKGROUND

• Teeman CS, Kurti SP, Cull BJ, Emerson SR, Haub MD, Rosenkranz SK. Postprandial lipemic and inflammatory responses to high-fat meals: a review of the roles of acute and chronic exercise. Nutr Metab (Lond). 2016 Nov 16;13:80. doi: 10.1186/s12986-016-0142-6. eCollection 2016.

  PMID: 27891165 BACKGROUND

• Piercy KL, Troiano RP, Ballard RM, Carlson SA, Fulton JE, Galuska DA, George SM, Olson RD. The Physical Activity Guidelines for Americans. JAMA. 2018 Nov 20;320(19):2020-2028. doi: 10.1001/jama.2018.14854.

  PMID: 30418471 BACKGROUND

• Padilla J, Harris RA, Fly AD, Rink LD, Wallace JP. The effect of acute exercise on endothelial function following a high-fat meal. Eur J Appl Physiol. 2006 Oct;98(3):256-62. doi: 10.1007/s00421-006-0272-z. Epub 2006 Aug 3.

  PMID: 16896723 BACKGROUND

MeSH Terms

Conditions

Motor Activity

Interventions

Diet; Exercise

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: March 3, 2022
• First Posted: March 23, 2022
• Study Start: March 28, 2022
• Primary Completion: November 1, 2022
• Study Completion: November 1, 2022
• Last Updated: January 31, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)