[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07728240":3,"trial-entities:NCT07728240":145,"trial-summary:NCT07728240":149},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":23,"study_type":30,"primary_purpose":15,"phases":31,"enrollment_info":32,"interventions":35,"primary_outcomes":42,"secondary_outcomes":57,"sex":80,"minimum_age":81,"maximum_age":82,"healthy_volunteers":83,"eligibility_criteria":84,"std_ages":103,"locations":105,"central_contacts":128,"overall_officials":131,"references":133,"see_also_links":144},"NCT07728240","2026-72","Diet, Metabolic Health, and Exercise Responses","Dietary Fat Quality, Metabolic Health, Cognitive Function, and Responses to Standardized Moderate-Intensity Exercise in Young Adults","RECRUITING","2027-07-31","2026-07","2026-07-27","2026-08-01","University of Wisconsin, River Falls","OTHER",null,"Regular physical activity, healthy dietary habits, and good metabolic health are associated with numerous physical and cognitive health benefits. However, individuals vary substantially in their affective, motivational, and cognitive responses to exercise, and the factors contributing to this variability are not fully understood.\n\nThis prospective observational study will examine whether habitual dietary fat quality and metabolic health are associated with exercise responses, cognitive function, and academic-related outcomes in healthy young adults. Participants will complete assessments of dietary intake, body composition, metabolic health, aerobic fitness, cognitive function, and academic engagement. They will also complete a standardized moderate-intensity cycling session during which affective responses, exercise enjoyment, subjective energy, and motivation for future physical activity will be assessed.\n\nThe findings will improve understanding of how habitual dietary habits and metabolic health may influence responses to exercise and cognitive functioning and may help inform future lifestyle recommendations aimed at promoting physical activity participation, cognitive performance, and overall health.","Regular physical activity and healthy dietary patterns contribute to the prevention of chronic disease and support cognitive and psychological well-being. Nevertheless, individuals differ considerably in their responses to exercise, including perceived enjoyment, affective responses, motivation to continue exercising, and cognitive performance. These individual differences may influence long-term physical activity participation and adherence, yet the biological and lifestyle factors underlying this variability remain incompletely understood.\n\nHabitual dietary fat quality and metabolic health have been independently associated with cardiometabolic function, cognition, and psychological well-being. Greater saturated fat intake and poorer metabolic health have been linked to impaired cognitive performance, increased inflammation, and reduced insulin sensitivity, whereas diets higher in unsaturated fats have been associated with more favorable metabolic and cognitive outcomes. Whether these factors also influence acute psychological and cognitive responses to exercise has received comparatively little attention.\n\nThe purpose of this prospective observational study is to examine associations among habitual dietary fat quality, metabolic health, cognitive function, and responses to a standardized bout of moderate-intensity exercise in healthy young adults. Habitual dietary intake will be assessed using multiple-day dietary records, and metabolic health will be characterized using anthropometric measurements, fasting glucose, blood lipids, oral glucose tolerance testing, body composition, aerobic fitness, and salivary cortisol. Cognitive function, mental fatigue, concentration, cognitive failures, and academic engagement will also be assessed.\n\nParticipants will complete a standardized moderate-intensity cycling session during which affective responses, perceived exertion, subjective energy, exercise enjoyment, and motivation for future physical activity will be measured before, during, and after exercise. The exercise session serves as a standardized assessment designed to evaluate individual variability in physiological and psychological responses rather than as an intervention intended to improve health outcomes.\n\nThe primary objective is to determine whether habitual dietary fat quality and metabolic health are associated with affective responses to exercise. Secondary objectives include examining associations with exercise enjoyment, motivation for future physical activity, cognitive performance, mental fatigue, concentration, academic engagement, and selected physiological measures. Findings from this study may improve understanding of modifiable lifestyle factors associated with exercise adherence, cognitive functioning, and overall health in young adults and inform future behavioral and lifestyle interventions.",[19,20,21,22],"Diet Quality","Metabolic Health","Cognitive Function","Exercise Response",[24,25,26,27,28,29],"Dietary fat quality","Metabolic health","Exercise affect","Exercise motivation","Cognitive function","Exercise enjoyment","OBSERVATIONAL",[],{"count":33,"type":34},100,"ESTIMATED",[36],{"type":37,"name":38,"description":39,"armGroupLabels":40},"BEHAVIORAL","Standardized Moderate-Intensity Cycling Session","Participants will complete a standardized 30-minute moderate-intensity cycling session on an electronically braked cycle ergometer. Exercise intensity will be prescribed at approximately 50-60% heart rate reserve (Borg Rating of Perceived Exertion 11-13). Heart rate, perceived exertion, affective responses, exercise enjoyment, subjective energy, and motivation will be assessed before, during, immediately after, and following exercise. The cycling session is conducted as a standardized assessment procedure for all participants and is not assigned as an experimental intervention.",[41],"Healthy Adults",[43,47,50,54],{"measure":44,"description":45,"timeFrame":46},"Affective Valence During and After Exercise","Affective valence will be assessed using the single-item Feeling Scale. Scores range from -5 (\"very bad\") to +5 (\"very good\"), with 0 representing \"neutral.\" Higher scores indicate more positive affective valence and therefore a better affective response.","Immediately before exercise; at minutes 5, 10, 15, 20, and 25 during the 30-minute cycling session; immediately after exercise; and 30 minutes after exercise",{"measure":48,"description":49,"timeFrame":46},"Perceived Arousal During and After Exercise","Perceived arousal will be assessed using the single-item Felt Arousal Scale. Scores range from 1 (\"low arousal\") to 6 (\"high arousal\"). Higher scores indicate greater perceived arousal and are not inherently a better or worse outcome.",{"measure":51,"description":52,"timeFrame":53},"Positive Affect Before and After Exercise","Positive affect will be assessed using the five-item positive-affect subscale of the International Positive and Negative Affect Schedule-Short Form. The five items are summed to produce a score ranging from 5 to 25. Higher scores indicate greater positive affect and therefore a better affective response.","Immediately before exercise, immediately after the 30-minute cycling session, and 30 minutes after exercise",{"measure":55,"description":56,"timeFrame":53},"Negative Affect Before and After Exercise","Negative affect will be assessed using the five-item negative-affect subscale of the International Positive and Negative Affect Schedule-Short Form. The five items are summed to produce a score ranging from 5 to 25. Higher scores indicate greater negative affect and therefore a worse affective response.",[58,62,66,69,73,77],{"measure":59,"description":60,"timeFrame":61},"Exercise Enjoyment","Exercise enjoyment will be assessed using the 8-item Physical Activity Enjoyment Scale-Short Form (PACES-SF). After reverse-scoring negatively worded items, responses are summed to produce a total score ranging from 8 to 56. Higher scores indicate greater exercise enjoyment and therefore a better outcome.","Immediately after the 30-minute cycling session and 30 minutes after the cycling session",{"measure":63,"description":64,"timeFrame":65},"Desire to Move","Momentary desire to move will be assessed using the Move subscale of the Cravings for Rest and Volitional Energy Expenditure (CRAVE) scale. Item responses are averaged to produce a score ranging from 0 to 10. Higher scores indicate a greater momentary desire to move but are not inherently a better or worse health outcome.","Immediately before the 30-minute cycling session, immediately after the cycling session, and 30 minutes after the cycling session",{"measure":67,"description":68,"timeFrame":65},"Desire to Rest","Momentary desire to rest will be assessed using the Rest subscale of the Cravings for Rest and Volitional Energy Expenditure (CRAVE) scale. Item responses are averaged to produce a score ranging from 0 to 10. Higher scores indicate a greater momentary desire to rest but are not inherently a better or worse health outcome.",{"measure":70,"description":71,"timeFrame":72},"Everyday Cognitive Failures","Everyday cognitive functioning will be assessed using the 25-item Cognitive Failures Questionnaire (CFQ). Items are summed to produce a total score ranging from 0 to 100. Higher scores indicate a greater frequency of everyday cognitive failures and therefore a worse outcome.","At baseline, before the exercise-testing procedures",{"measure":74,"description":75,"timeFrame":76},"Estimated Maximal Oxygen Consumption","Aerobic fitness will be estimated during a submaximal graded cycle-ergometer exercise test with respiratory gas analysis. Estimated maximal oxygen consumption will be reported in milliliters of oxygen per kilogram of body mass per minute. Higher values indicate greater aerobic fitness and therefore a better outcome.","At baseline, during the submaximal graded cycle-ergometer test",{"measure":78,"description":79,"timeFrame":72},"Body Composition","Body composition will be assessed using air-displacement plethysmography (BodPod) and reported as the percentage of total body mass consisting of fat. Higher values indicate a greater proportion of body mass consisting of fat.","ALL","18 Years","60 Years",false,{"inclusion":85,"exclusion":91,"raw_text":102},[86,87,88,89,90],"Age 18 years or older.","Able to provide written informed consent.","Able and willing to complete two laboratory visits, dietary recording, cognitive assessments, and exercise testing.","Able to safely complete submaximal exercise testing and a 30-minute moderate-intensity cycling session, as determined by health-history screening and the Physical Activity Readiness Questionnaire Plus (PAR-Q+).","Willing to complete dietary records and follow pre-visit instructions.",[92,93,94,95,96,97,98,99,100,101],"Known cardiovascular, pulmonary, metabolic, neurological, psychiatric, or other medical condition that could make exercise testing or moderate-intensity exercise unsafe or substantially affect study outcomes.","Current pregnancy.","Current smoking.","Medication use that could substantially affect metabolic, cardiovascular, cognitive, or exercise-response outcomes, as determined by the investigators.","Resting heart rate greater than 100 beats per minute.","Resting blood pressure greater than 160\u002F100 mmHg.","Electrocardiogram abnormality requiring further medical evaluation.","Positive PAR-Q+ response or other health-screening finding indicating that medical clearance is required and has not been obtained.","Inability or unwillingness to complete study procedures, fasting requirements, dietary records, or pre-visit restrictions.","Any other condition that, in the judgment of the research team, would make participation unsafe or interfere with valid completion of the study procedures.","Inclusion Criteria:\n\n* Age 18 years or older.\n* Able to provide written informed consent.\n* Able and willing to complete two laboratory visits, dietary recording, cognitive assessments, and exercise testing.\n* Able to safely complete submaximal exercise testing and a 30-minute moderate-intensity cycling session, as determined by health-history screening and the Physical Activity Readiness Questionnaire Plus (PAR-Q+).\n* Willing to complete dietary records and follow pre-visit instructions.\n\nExclusion Criteria:\n\n* Known cardiovascular, pulmonary, metabolic, neurological, psychiatric, or other medical condition that could make exercise testing or moderate-intensity exercise unsafe or substantially affect study outcomes.\n* Current pregnancy.\n* Current smoking.\n* Medication use that could substantially affect metabolic, cardiovascular, cognitive, or exercise-response outcomes, as determined by the investigators.\n\nOrthopedic injury, mobility limitation, or other physical condition that prevents safe cycling or exercise testing.\n\n* Resting heart rate greater than 100 beats per minute.\n* Resting blood pressure greater than 160\u002F100 mmHg.\n* Electrocardiogram abnormality requiring further medical evaluation.\n* Positive PAR-Q+ response or other health-screening finding indicating that medical clearance is required and has not been obtained.\n* Inability or unwillingness to complete study procedures, fasting requirements, dietary records, or pre-visit restrictions.\n* Any other condition that, in the judgment of the research team, would make participation unsafe or interfere with valid completion of the study procedures.",[104],"ADULT",[106],{"facility":107,"status":8,"city":108,"state":109,"zip":110,"country":111,"contacts":112,"geoPoint":125},"University of Wisconsin-River Falls","River Falls","Wisconsin","54022","United States",[113,118,122],{"name":114,"role":115,"phone":116,"email":117},"Gregory Ruegsegger, PhD","CONTACT","715-425-4945","gregory.ruegsegger@uwrf.edu",{"name":119,"role":115,"phone":120,"email":121},"Ricky Lopez, MS","715-425-4138","ricky.lopez@uwrf.edu",{"name":123,"role":124},"Gregory N Ruegsegger, PhD","PRINCIPAL_INVESTIGATOR",{"lat":126,"lon":127},44.86136,-92.62381,[129,130],{"name":114,"role":115,"phone":116,"email":117},{"name":119,"role":115,"phone":120,"email":121},[132],{"name":114,"affiliation":13,"role":124},[134,138,141],{"pmid":135,"type":136,"citation":137},"36750220","BACKGROUND","Hartman ME, Hernandez J. The Assessment of Affective Responses within Exercise Prescription: A Narrative Review. Int J Sports Med. 2023 Jul;44(8):558-567. doi: 10.1055\u002Fa-2029-8337. Epub 2023 Feb 7.",{"pmid":139,"type":136,"citation":140},"21780850","Ekkekakis P, Parfitt G, Petruzzello SJ. The pleasure and displeasure people feel when they exercise at different intensities: decennial update and progress towards a tripartite rationale for exercise intensity prescription. Sports Med. 2011 Aug 1;41(8):641-71. doi: 10.2165\u002F11590680-000000000-00000.",{"pmid":142,"type":136,"citation":143},"14715206","Ekkekakis P, Hall EE, Petruzzello SJ. Practical markers of the transition from aerobic to anaerobic metabolism during exercise: rationale and a case for affect-based exercise prescription. Prev Med. 2004 Feb;38(2):149-59. doi: 10.1016\u002Fj.ypmed.2003.09.038.",[],{"nct_id":4,"conditions":146,"biomarkers":148},[147,19,22,20],"Cognitive Dysfunction",[],{"nct_id":4,"found":150,"summary":151,"prompt_version":161},true,{"design":152,"status":153,"heading":154,"summary":155,"follow_up":156,"word_count":157,"commitments":158,"compensation":159,"drugs_mentioned":160},"This is an observational study, meaning researchers will observe and collect information without giving you a specific treatment. It plans to include 100 participants.","completed","Diet, Metabolic Health, and Exercise Responses Study","This observational study is looking at how your diet, specifically fat quality, and your metabolic health (how your body uses energy) might be connected to your responses to exercise and your brain function. Researchers want to understand why people react differently to exercise. You might be able to join if you are between 18 and 60 years old, can complete two lab visits, and are able to safely do moderate-intensity cycling. The study will measure your feelings during and after a 30-minute cycling session, as well as your perceived arousal (how alert or stimulated you feel) and positive emotions. The current status of this study is unclear, and it plans to enroll 100 participants.","Your affective valence, perceived arousal, and positive affect will be measured immediately before, during, immediately after, and 30 minutes after the 30-minute cycling session.",114,"You would complete two laboratory visits, record your diet, undergo cognitive assessments, and participate in exercise testing, including a 30-minute moderate-intensity cycling session.","Not stated in the trial record.",[],"v2"]