Metabolic SyndromeNCT05001126
The Dose-response Effects of High Intensity Functional Training on Metabolic Syndrome Risk Factors
A study testing HIFT 1x/week, HIFT 2x/week and HIFT 3x/week in people with Metabolic Syndrome and Atherogenic Dyslipidemia, run by Gary Van Guilder at 1 site in United States.
Trial summary
This study aims to explore the dose effects of three weekly volumes of high-intensity functional training (HIFT) on apolipoprotein B (ApoB), triglyceride (TG) and cholesterol (CHOL) content of low-density lipoproteins (LDL), very low-density lipoproteins (VLDL), and high-density lipoproteins (HDL) particles, fasting… Read more about this study
- Who is it for?
- Ages 35 to 65 years
- Conditions the study is for
- Metabolic Syndrome, Atherogenic Dyslipidemia, Insulin Resistance
- What is being tested?
- HIFT 1x/week, HIFT 2x/week and HIFT 3x/week
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2022to 31 May 2023
- 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 35 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Physically Inactive (< 30 min/day, 3 days/wk, for 3 months of moderate intensity exercise)
- Possess at least 3 of the following 5 risk factors defining metabolic syndrome (MetS): waist circumference ≥ 102cm (men) or ≥ 88cm (women), resting blood pressure ≥ 130/85, HDL-C ≤ 40mg/dl (men) or ≤ 50mg/dl (women), fasting triglycerides ≥ 150mg/dl, and fasting blood glucose ≥ 100mg/dl.
Who cannot join
- Diagnosed heart, lung, kidney, liver, pancreatic or neurological disease
- Pregnant or plan to become pregnant
- Medical or orthopedic conditions preventing participation in exercise
Trial locations and contacts
1 site in 1 country.
United States1 site
Western Colorado University
Gunnison, Colorado, 81230
About this study
Official title: The Effects of High Intensity Functional Training on Cardiometabolic Risk Factors and Exercise Enjoyment in Men and Women With Metabolic Syndrome: a Randomized, 12-week, Dose-response Trial
This study aims to explore the dose effects of three weekly volumes of high-intensity functional training (HIFT) on apolipoprotein B (ApoB), triglyceride (TG) and cholesterol (CHOL) content of low-density lipoproteins (LDL), very low-density lipoproteins (VLDL), and high-density lipoproteins (HDL) particles, fasting insulin and glucose, glycosylated hemoglobin (HbA1c), and endothelial function after a 12-week training program. Secondarily, this study aims to also explore the subjective dose-responses of "exercise enjoyment" and "intention to continue" after this 12-week training program.
Read the detailed description
Background: Individuals with metabolic syndrome (MetS) are at a greater risk for developing atherosclerotic cardiovascular disease (ASCVD) than those without MetS, due to underlying endothelial dysfunction, dyslipidemia, and insulin resistance. Exercise is an effective primary and secondary prevention strategy for MetS, however less than 25% of adults meet the minimum stated public recommendations. Barriers often identified are lack of enjoyment and lack of time. High intensity functional training (HIFT), a time efficient modality of exercise, has shown some potential to elicit positive affectivity, and elicit increased fitness and improved glucose metabolism. However, the effects of HIFT on dyslipidemia and endothelial dysfunction have not been explored, nor have the effects been explored in a population with MetS. Additionally, no studies have investigated the minimal dose of HIFT per week to see clinically meaningful changes in cardiometabolic health. The purpose of this study is to: 1) determine the dose-response effect of HIFT on blood lipids, insulin resistance, and endothelial function, and 2) determine the dose-response effect of HIFT on body composition, fitness, and perceived enjoyment and intention to continue the exercise.
Methods/design: In this randomized, dose-response trial, participants will undergo a 12-week HIFT intervention of either 1 day/week, 2 days/week, or 3 days/week of supervised, progressive exercise. Outcomes assessed at baseline and post-intervention will be multiple cardiometabolic markers, and fitness. Additionally, the participant's affective response will be measured after the intervention.
Discussion: The findings of this research will provide evidence on the minimal dose of HIFT per week to see clinically meaningful improvements in the risk factors of MetS, as well as whether this modality is likely to mitigate the barriers to exercise. If an effective dose of HIFT per week is determined and if this modality is perceived positively, it may provide exercise specialists and health care providers a tool to prevent and treat MetS.
- Being tested
- HIFT 1x/week, HIFT 2x/week, HIFT 3x/week
- Keywords
- Exercise
- Medical subject headings
- Metabolic Syndrome, Insulin Resistance, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HIFT 1x/weekBehavioural
HIFT is a time-efficient modality of exercise combining high-intensity aerobic and resistance training using minimal equipment. HIFT 1x/week represents a dose of one HIFT workout per week.
HIFT 2x/weekBehavioural
HIFT is a time-efficient modality of exercise combining high-intensity aerobic and resistance training using minimal equipment. HIFT 2x/week represents a dose of two HIFT workouts per week.
HIFT 3x/weekBehavioural
HIFT is a time-efficient modality of exercise combining high-intensity aerobic and resistance training using minimal equipment. HIFT 3x/week represents a dose of three HIFT workouts per week.
| Study group | Role | What they receive |
|---|---|---|
| HIFT 1x/week | Experimental | HIFT exercise performed one time per week. Receives: Behavioral: HIFT 1x/week |
| HIFT 2x/week | Experimental | HIFT exercise performed two times per week. Receives: Behavioral: HIFT 2x/week |
| HIFT 3x/week | Experimental | HIFT exercise performed three times per week. Receives: Behavioral: HIFT 3x/week |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change from baseline and comparison between groups in apolipoprotein B (ApoB) count after 12 weeks of training.
Baseline and post-training blood analysis of apolipoprotein B will be measured via venipuncture of the anti-cubital vein and reported in units of mg/dL. Change from baseline will be calculated and aggregated as mean (SD) for each dose group as well as for male and female subgroups within each dose group. The mean (SD) change will be compared between the three dose groups and male and female subgroups.
Measured: Baseline and 48hrs post 12-week training completion
Mean change from baseline and comparison between groups in the cholesterol content of low-density lipoproteins (LDL-C).
Baseline and post-training blood analysis of LDL-C will be measured via venipuncture of the anti-cubital vein and reported in units of mg/dL. Change from baseline will be calculated and aggregated as mean (SD) for each dose group as well as for male and female subgroups within each dose group. The mean (SD) change will be compared between the three dose groups and male and female subgroups.
Measured: Baseline and 48hrs post 12-week training completion
Mean change from baseline and comparison between groups in the cholesterol content of very low-density lipoproteins (VLDL-C).
Baseline and post-training blood analysis of VLDL-C will be measured via venipuncture of the anti-cubital vein and reported in units of mg/dL. Change from baseline will be calculated and aggregated as mean (SD) for each dose group as well as for male and female subgroups within each dose group. The mean (SD) change will be compared between the three dose groups and male and female subgroups.
Measured: Baseline and 48hrs post 12-week training completion
Mean change from baseline and comparison between groups in the cholesterol content of high-density lipoproteins (HDL-C).
Baseline and post-training blood analysis of HDL-C will be measured via venipuncture of the anti-cubital vein and reported in units of mg/dL. Change from baseline will be calculated and aggregated as mean (SD) for each dose group as well as for male and female subgroups within each dose group. The mean (SD) change will be compared between the three dose groups and male and female subgroups.
Measured: Baseline and 48hrs post 12-week training completion
Mean change from baseline and comparison between groups in the total cholesterol (TC) content of all lipoproteins.
Baseline and post-training blood analysis of TC will be measured via venipuncture of the anti-cubital vein and reported in units of mg/dL. Change from baseline will be calculated and aggregated as mean (SD) for each dose group as well as for male and female subgroups within each dose group. The mean (SD) change will be compared between the three dose groups and male and female subgroups.
Measured: Baseline and 48hrs post 12-week training completion
Mean change from baseline and comparison between groups in the triglyceride content of LDL (LDL-T).
Baseline and post-training blood analysis of LDL-T will be measured via venipuncture of the anti-cubital vein and reported in units of mg/dL. Change from baseline will be calculated and aggregated as mean (SD) for each dose group as well as for male and female subgroups within each dose group. The mean (SD) change will be compared between the three dose groups and male and female subgroups.
Measured: Baseline and 48hrs post 12-week training completion
Mean change from baseline and comparison between groups in the triglyceride content of VLDL (VLDL-T).
Baseline and post-training blood analysis of VLDL-T will be measured via venipuncture of the anti-cubital vein and reported in units of mg/dL. Change from baseline will be calculated and aggregated as mean (SD) for each dose group as well as for male and female subgroups within each dose group. The mean (SD) change will be compared between the three dose groups and male and female subgroups.
Measured: Baseline and 48hrs post 12-week training completion
Mean change from baseline and comparison between groups in the total triglyceride content of all lipoprotein classes (TG).
Baseline and post-training blood analysis of TG will be measured via venipuncture of the anti-cubital vein and reported in units of mg/dL. Change from baseline will be calculated and aggregated as mean (SD) for each dose group as well as for male and female subgroups within each dose group. The mean (SD) change will be compared between the three dose groups and male and female subgroups.
Measured: Baseline and 48hrs post 12-week training completion
Mean change from baseline and comparison between groups in blood glucose (BG).
Baseline and post-training blood analysis of BG will be measured via venipuncture of the anti-cubital vein and reported in units of mg/dL. Change from baseline will be calculated and aggregated as mean (SD) for each dose group as well as for male and female subgroups within each dose group. The mean (SD) change for each variable will be compared between the three dose groups and male and female subgroups.
Measured: Baseline and 48hrs post 12-week training completion
Mean change from baseline and comparison between groups in blood insulin (INS).
Baseline and post-training blood analysis of INS will be measured via venipuncture of the anti-cubital vein and reported in units of mcIU/mL. Change from baseline will be calculated and aggregated as mean (SD) for each dose group as well as for male and female subgroups within each dose group. The mean (SD) change for each variable will be compared between the three dose groups and male and female subgroups.
Measured: Baseline and 48hrs post 12-week training completion
Mean change from baseline and comparison between groups in the Homeostatic Assessment of Insulin Resistance (HOMA-IR).
The baseline and post-training blood analysis of BG and INS will be used to calculate insulin resistance (IR) using the validated homeostatic model assessment (HOMA) [Sarafidis et al., 2007; Matthews et al., 1985]. HOMA-IR will be reported in units of mg/dL. Change from baseline will be calculated and aggregated as mean (SD) for each dose group as well as for male and female subgroups within each dose group. The mean (SD) change for each variable will be compared between the three dose groups and male and female subgroups.
Measured: Baseline and 48hrs post 12-week training completion
Mean change from baseline and comparison between groups in glycosylated hemoglobin (HbA1c) after 12 weeks of training.
Baseline and post-training blood analysis of HbA1c will be measured via venipuncture of the anti-cubital vein and reported in units of percent (%). Change from baseline will be calculated and aggregated as mean (SD) for each dose group as well as for male and female subgroups within each dose group. The mean (SD) change for each variable will be compared between the three dose groups and male and female subgroups.
Measured: Baseline and 48hrs post 12-week training completion
Mean change from baseline and comparison between groups of endothelial-dependent peak blood flow (PBF).
Baseline and post-training endothelial-dependent PBF of the non-dominant forearm will be measured using venous occlusion strain-gauge plethysmography and reported in units of percent (%). Change from baseline will be calculated and aggregated as mean (SD) for each dose group and male/female subgroups. Mean (SD) for each variable will be compared between dose groups and male and female subgroups.
Measured: Baseline and 48hrs post 12-week training completion
Mean change from baseline and comparison between groups of endothelial-dependent area under the curve (AUC) of hyperemia blood flow.
Baseline and post-training endothelial-dependent hyperemia AUC of the non-dominant forearm will be measured using venous occlusion strain-gauge plethysmography. Hyperemia blood flow will be measured for 5 min after a 5 min occlusion period. 30 sec AUC blood flow will be quantified reported in units of percent (%) x time. Change from baseline will be calculated and aggregated as mean (SD) for each dose group and male/female subgroups. Mean (SD) for each variable will be compared between dose groups and male and female subgroups.
Measured: Baseline and 48hrs post 12-week training completion
Secondary outcomes (4)
Mean change from baseline and comparison between groups of body fat mass percentage (FM%).
Baseline and post-training FM% will be measured via dual X-ray absorptiometry (DEXA) and reported as percentage of total body mass. Change from baseline will be calculated and aggregated as mean (SD) for each dose group and male and female subgroups. Mean (SD) will be compared between dose groups and male and female subgroups.
Measured: Baseline and 48hrs post 12-week training completion
Mean change from baseline and comparison between groups of body lean mass percentage (LM%).
Baseline and post-training LM% will be measured via dual X-ray absorptiometry (DEXA) and reported as percentage of total body mass. Change from baseline will be calculated and aggregated as mean (SD) for each dose group and male and female subgroups. Mean (SD) will be compared between dose groups and male and female subgroups.
Measured: Baseline and 48hrs post 12-week training completion
Mean change from baseline and comparison between groups in maximal oxygen consumption (VO2max).
Baseline and post-training VO2max will be measured via a graded exercise test (GXT) on a power treadmill. After a 5 min warm-up, participants will walk at a constant speed while incline is increased 1% each minute until volitional exhaustion [Balke \& Ware, 1959] while VO2 is continuously captured. VO2max will be recorded and reported in units of mL/kg/min. Participants will rest passively for 20 min then perform a verification trial at 105% of their maximal GXT workload while VO2 is continuously captured until volitional exhaustion. If VO2max of the verification bout and GXT are within ± 3%, true VO2max will be considered achieved [Astorino et al., 2009; Nolan et al., 2014; Weatherwax et al., 2016]. If verification is not achieved, they will repeat the trial after a 24hr rest. Change from baseline will be calculated and aggregated as mean (SD) for each dose group and male/female subgroups. Mean (SD) will be compared between the three dose groups and male/female subgroups.
Measured: Baseline and 48hrs post 12-week training completion
Mean change from baseline and comparison between groups of self-perceived fitness after 12 weeks of training.
Baseline and post-training self-perceived fitness will be measured using the validated International Fitness Scale (IFIS) [Ortega et al., 2011; Merellano-Navarro et al., 2017] and reported as the sum of all scores. The scale contains five questions with the answering options (Very Poor-1, Poor-2, Average-3, Good-4, Very Good-5) associated to these elements of physical fitness: cardiorespiratory endurance, muscular strength, speed-agility, and flexibility. Change from baseline will be calculated and aggregated as mean (SD) for each dose group and male/female subgroups. Mean (SD) will be compared between the three dose groups and male/female subgroups.
Measured: Baseline and 48hrs post 12-week training completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2021
- Study start1 Sep 2022
- Primary completion31 Dec 2022
- Study completion31 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Metabolic SyndromeStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- Three dose groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gary Van Guilder
- Sponsor type
- University, hospital or other
- Collaborators
- Western Colorado University, Auckland University of Technology
- Responsible party
- Sponsor-investigator, Gary Van Guilder, Western Colorado University
- Investigators
- Lance C Dalleck, PhD, Principal investigator, Western Colorado UniversityNigel Harris, PhD, Principal investigator, Auckland University of Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05001126
- Sponsor's protocol ID
- WCU_HIFT_MetS
- Status last verified
- Apr 2024
- First submitted
- 14 Jul 2021
- Last updated
- 23 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified IPD will be available upon request.
Publications
Sarafidis PA, Lasaridis AN, Nilsson PM, Pikilidou MI, Stafilas PC, Kanaki A, Kazakos K, Yovos J, Bakris GL. Validity and reproducibility of HOMA-IR, 1/HOMA-IR, QUICKI and McAuley's indices in patients with hypertension and type II diabetes. J Hum Hypertens. 2007 Sep;21(9):709-16. doi: 10.1038/sj.jhh.1002201. Epub 2007 Apr 19.
PubMed 17443211Matthews DR, Hosker JP, Rudenski AS, Naylor BA, Treacher DF, Turner RC. Homeostasis model assessment: insulin resistance and beta-cell function from fasting plasma glucose and insulin concentrations in man. Diabetologia. 1985 Jul;28(7):412-9. doi: 10.1007/BF00280883.
PubMed 3899825Ortega FB, Ruiz JR, Espana-Romero V, Vicente-Rodriguez G, Martinez-Gomez D, Manios Y, Beghin L, Molnar D, Widhalm K, Moreno LA, Sjostrom M, Castillo MJ; HELENA study group. The International Fitness Scale (IFIS): usefulness of self-reported fitness in youth. Int J Epidemiol. 2011 Jun;40(3):701-11. doi: 10.1093/ije/dyr039. Epub 2011 Mar 24.
PubMed 21441238Merellano-Navarro E, Collado-Mateo D, Garcia-Rubio J, Gusi N, Olivares PR. Validity of the International Fitness Scale "IFIS" in older adults. Exp Gerontol. 2017 Sep;95:77-81. doi: 10.1016/j.exger.2017.05.001. Epub 2017 May 2.
PubMed 28476584BALKE B, WARE RW. The present status of physical fitness in the Air Force. Proj Rep USAF Sch Aviat Med. 1959 May;59(67):1-9. No abstract available.
PubMed 24546008Astorino TA, White AC, Dalleck LC. Supramaximal testing to confirm attainment of VO2max in sedentary men and women. Int J Sports Med. 2009 Apr;30(4):279-84. doi: 10.1055/s-0028-1104588. Epub 2009 Feb 6.
PubMed 19199208Nolan PB, Beaven ML, Dalleck L. Comparison of intensities and rest periods for VO2max verification testing procedures. Int J Sports Med. 2014 Nov;35(12):1024-9. doi: 10.1055/s-0034-1367065. Epub 2014 Jun 2.
PubMed 24886925Weatherwax RM, Richardson TB, Beltz NM, Nolan PB, Dalleck L. Verification Testing to Confirm VO2max in Altitude-Residing, Endurance-Trained Runners. Int J Sports Med. 2016 Jun;37(7):525-30. doi: 10.1055/s-0035-1569346. Epub 2016 Apr 29.
PubMed 27128112Kendzierski D and DeCarlo KJ. Physical activity enjoyment scale: Two validation studies. Journal of Sport and Exercise Psychology. 1991; 13:50-64.
Kwan BM, Bryan A. In-task and post-task affective response to exercise: translating exercise intentions into behaviour. Br J Health Psychol. 2010 Feb;15(Pt 1):115-31. doi: 10.1348/135910709X433267. Epub 2009 Apr 25.
PubMed 19397847Heinrich KM, Crawford DA, Johns BR, Frye J, and Gilmore KEO. Affective responses during high-intensity functional training compared to high-intensity interval training and moderate continuous training. Sport, Exercise, and Performance Psychology. 2019;9(1):115-127.
Smith LE, Van Guilder GP, Dalleck LC, Harris NK. The effects of high-intensity functional training on cardiometabolic risk factors and exercise enjoyment in men and women with metabolic syndrome: study protocol for a randomized, 12-week, dose-response trial. Trials. 2022 Mar 1;23(1):182. doi: 10.1186/s13063-022-06100-7.
PubMed 35232475
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of High Intensity Functional Training on Cardiometabolic Risk Factors and Exercise Enjoyment in Men and Women With Metabolic Syndrome: a Randomized, 12-week, Dose-response Trial
- ClinicalTrials.gov ID
- NCT05001126
- Acronym / sponsor ID
- WCU_HIFT_MetS
- Keywords
- Exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Gary Van GuilderUniversity, hospital or other
- Collaborators
- Western Colorado University, Auckland University of Technology
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 May 2023 (actual)
- First posted
- 11 Aug 2021 (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.
This study aims to explore the dose effects of three weekly volumes of high-intensity functional training (HIFT) on apolipoprotein B (ApoB), triglyceride (TG) and cholesterol (CHOL) content of low-density lipoproteins (LDL), very low-density lipoproteins (VLDL), and high-density lipoproteins (HDL) particles, fasting insulin and glucose, glycosylated hemoglobin (HbA1c), and endothelial function after a 12-week training program. Secondarily, this study aims to also explore the subjective dose-responses of "exercise enjoyment" and "intention to continue" after this 12-week training program.
Detailed description
Background: Individuals with metabolic syndrome (MetS) are at a greater risk for developing atherosclerotic cardiovascular disease (ASCVD) than those without MetS, due to underlying endothelial dysfunction, dyslipidemia, and insulin resistance. Exercise is an effective primary and secondary prevention strategy for MetS, however less than 25% of adults meet the minimum stated public recommendations. Barriers often identified are lack of enjoyment and lack of time. High intensity functional training (HIFT), a time efficient modality of exercise, has shown some potential to elicit positive affectivity, and elicit increased fitness and improved glucose metabolism. However, the effects of HIFT on dyslipidemia and endothelial dysfunction have not been explored, nor have the effects been explored in a population with MetS. Additionally, no studies have investigated the minimal dose of HIFT per week to see clinically meaningful changes in cardiometabolic health. The purpose of this study is to: 1) determine the dose-response effect of HIFT on blood lipids, insulin resistance, and endothelial function, and 2) determine the dose-response effect of HIFT on body composition, fitness, and perceived enjoyment and intention to continue the exercise.
Methods/design: In this randomized, dose-response trial, participants will undergo a 12-week HIFT intervention of either 1 day/week, 2 days/week, or 3 days/week of supervised, progressive exercise. Outcomes assessed at baseline and post-intervention will be multiple cardiometabolic markers, and fitness. Additionally, the participant's affective response will be measured after the intervention.
Discussion: The findings of this research will provide evidence on the minimal dose of HIFT per week to see clinically meaningful improvements in the risk factors of MetS, as well as whether this modality is likely to mitigate the barriers to exercise. If an effective dose of HIFT per week is determined and if this modality is perceived positively, it may provide exercise specialists and health care providers a tool to prevent and treat MetS.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind (investigator)
- Number of arms
- 3
- Model description
- Three dose groups
| Arm | Type | Receives |
|---|---|---|
| HIFT 1x/week | Experimental | Behavioral: HIFT 1x/weekHIFT exercise performed one time per week. |
| HIFT 2x/week | Experimental | Behavioral: HIFT 2x/weekHIFT exercise performed two times per week. |
| HIFT 3x/week | Experimental | Behavioral: HIFT 3x/weekHIFT exercise performed three times per week. |
Who may qualify
- Ages
- 35 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Physically Inactive (< 30 min/day, 3 days/wk, for 3 months of moderate intensity exercise)
- Possess at least 3 of the following 5 risk factors defining metabolic syndrome (MetS): waist circumference ≥ 102cm (men) or ≥ 88cm (women), resting blood pressure ≥ 130/85, HDL-C ≤ 40mg/dl (men) or ≤ 50mg/dl (women), fasting triglycerides ≥ 150mg/dl, and fasting blood glucose ≥ 100mg/dl.
Key exclusion criteria (3 listed)
- Diagnosed heart, lung, kidney, liver, pancreatic or neurological disease
- Pregnant or plan to become pregnant
- Medical or orthopedic conditions preventing participation in exercise
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 |
|---|---|---|
| HIFT 1x/weekHIFT is a time-efficient modality of exercise combining high-intensity aerobic and resistance training using minimal equipment. HIFT 1x/week represents a dose of one HIFT workout per week. | Behavioural | HIFT 1x/week |
| HIFT 2x/weekHIFT is a time-efficient modality of exercise combining high-intensity aerobic and resistance training using minimal equipment. HIFT 2x/week represents a dose of two HIFT workouts per week. | Behavioural | HIFT 2x/week |
| HIFT 3x/weekHIFT is a time-efficient modality of exercise combining high-intensity aerobic and resistance training using minimal equipment. HIFT 3x/week represents a dose of three HIFT workouts per week. | Behavioural | HIFT 3x/week |
Primary outcome
Mean change from baseline and comparison between groups in apolipoprotein B (ApoB) count after 12 weeks of training.
Time frame: Baseline and 48hrs post 12-week training completion
Baseline and post-training blood analysis of apolipoprotein B will be measured via venipuncture of the anti-cubital vein and reported in units of mg/dL. Change from baseline will be calculated and aggregated as mean (SD) for each dose group as well as for male and female subgroups within each dose group. The mean (SD) change will be compared between the three dose groups and male and female subgroups.
Mean change from baseline and comparison between groups in the cholesterol content of low-density lipoproteins (LDL-C).
Time frame: Baseline and 48hrs post 12-week training completion
Baseline and post-training blood analysis of LDL-C will be measured via venipuncture of the anti-cubital vein and reported in units of mg/dL. Change from baseline will be calculated and aggregated as mean (SD) for each dose group as well as for male and female subgroups within each dose group. The mean (SD) change will be compared between the three dose groups and male and female subgroups.
Mean change from baseline and comparison between groups in the cholesterol content of very low-density lipoproteins (VLDL-C).
Time frame: Baseline and 48hrs post 12-week training completion
Baseline and post-training blood analysis of VLDL-C will be measured via venipuncture of the anti-cubital vein and reported in units of mg/dL. Change from baseline will be calculated and aggregated as mean (SD) for each dose group as well as for male and female subgroups within each dose group. The mean (SD) change will be compared between the three dose groups and male and female subgroups.
Mean change from baseline and comparison between groups in the cholesterol content of high-density lipoproteins (HDL-C).
Time frame: Baseline and 48hrs post 12-week training completion
Baseline and post-training blood analysis of HDL-C will be measured via venipuncture of the anti-cubital vein and reported in units of mg/dL. Change from baseline will be calculated and aggregated as mean (SD) for each dose group as well as for male and female subgroups within each dose group. The mean (SD) change will be compared between the three dose groups and male and female subgroups.
Mean change from baseline and comparison between groups in the total cholesterol (TC) content of all lipoproteins.
Time frame: Baseline and 48hrs post 12-week training completion
Baseline and post-training blood analysis of TC will be measured via venipuncture of the anti-cubital vein and reported in units of mg/dL. Change from baseline will be calculated and aggregated as mean (SD) for each dose group as well as for male and female subgroups within each dose group. The mean (SD) change will be compared between the three dose groups and male and female subgroups.
Mean change from baseline and comparison between groups in the triglyceride content of LDL (LDL-T).
Time frame: Baseline and 48hrs post 12-week training completion
Baseline and post-training blood analysis of LDL-T will be measured via venipuncture of the anti-cubital vein and reported in units of mg/dL. Change from baseline will be calculated and aggregated as mean (SD) for each dose group as well as for male and female subgroups within each dose group. The mean (SD) change will be compared between the three dose groups and male and female subgroups.
Mean change from baseline and comparison between groups in the triglyceride content of VLDL (VLDL-T).
Time frame: Baseline and 48hrs post 12-week training completion
Baseline and post-training blood analysis of VLDL-T will be measured via venipuncture of the anti-cubital vein and reported in units of mg/dL. Change from baseline will be calculated and aggregated as mean (SD) for each dose group as well as for male and female subgroups within each dose group. The mean (SD) change will be compared between the three dose groups and male and female subgroups.
Mean change from baseline and comparison between groups in the total triglyceride content of all lipoprotein classes (TG).
Time frame: Baseline and 48hrs post 12-week training completion
Baseline and post-training blood analysis of TG will be measured via venipuncture of the anti-cubital vein and reported in units of mg/dL. Change from baseline will be calculated and aggregated as mean (SD) for each dose group as well as for male and female subgroups within each dose group. The mean (SD) change will be compared between the three dose groups and male and female subgroups.
Mean change from baseline and comparison between groups in blood glucose (BG).
Time frame: Baseline and 48hrs post 12-week training completion
Baseline and post-training blood analysis of BG will be measured via venipuncture of the anti-cubital vein and reported in units of mg/dL. Change from baseline will be calculated and aggregated as mean (SD) for each dose group as well as for male and female subgroups within each dose group. The mean (SD) change for each variable will be compared between the three dose groups and male and female subgroups.
Mean change from baseline and comparison between groups in blood insulin (INS).
Time frame: Baseline and 48hrs post 12-week training completion
Baseline and post-training blood analysis of INS will be measured via venipuncture of the anti-cubital vein and reported in units of mcIU/mL. Change from baseline will be calculated and aggregated as mean (SD) for each dose group as well as for male and female subgroups within each dose group. The mean (SD) change for each variable will be compared between the three dose groups and male and female subgroups.
Mean change from baseline and comparison between groups in the Homeostatic Assessment of Insulin Resistance (HOMA-IR).
Time frame: Baseline and 48hrs post 12-week training completion
The baseline and post-training blood analysis of BG and INS will be used to calculate insulin resistance (IR) using the validated homeostatic model assessment (HOMA) [Sarafidis et al., 2007; Matthews et al., 1985]. HOMA-IR will be reported in units of mg/dL. Change from baseline will be calculated and aggregated as mean (SD) for each dose group as well as for male and female subgroups within each dose group. The mean (SD) change for each variable will be compared between the three dose groups and male and female subgroups.
Mean change from baseline and comparison between groups in glycosylated hemoglobin (HbA1c) after 12 weeks of training.
Time frame: Baseline and 48hrs post 12-week training completion
Baseline and post-training blood analysis of HbA1c will be measured via venipuncture of the anti-cubital vein and reported in units of percent (%). Change from baseline will be calculated and aggregated as mean (SD) for each dose group as well as for male and female subgroups within each dose group. The mean (SD) change for each variable will be compared between the three dose groups and male and female subgroups.
Mean change from baseline and comparison between groups of endothelial-dependent peak blood flow (PBF).
Time frame: Baseline and 48hrs post 12-week training completion
Baseline and post-training endothelial-dependent PBF of the non-dominant forearm will be measured using venous occlusion strain-gauge plethysmography and reported in units of percent (%). Change from baseline will be calculated and aggregated as mean (SD) for each dose group and male/female subgroups. Mean (SD) for each variable will be compared between dose groups and male and female subgroups.
Mean change from baseline and comparison between groups of endothelial-dependent area under the curve (AUC) of hyperemia blood flow.
Time frame: Baseline and 48hrs post 12-week training completion
Baseline and post-training endothelial-dependent hyperemia AUC of the non-dominant forearm will be measured using venous occlusion strain-gauge plethysmography. Hyperemia blood flow will be measured for 5 min after a 5 min occlusion period. 30 sec AUC blood flow will be quantified reported in units of percent (%) x time. Change from baseline will be calculated and aggregated as mean (SD) for each dose group and male/female subgroups. Mean (SD) for each variable will be compared between dose groups and male and female subgroups.
4 secondary outcomes
Mean change from baseline and comparison between groups of body fat mass percentage (FM%).
Time frame: Baseline and 48hrs post 12-week training completion
Mean change from baseline and comparison between groups of body lean mass percentage (LM%).
Time frame: Baseline and 48hrs post 12-week training completion
Mean change from baseline and comparison between groups in maximal oxygen consumption (VO2max).
Time frame: Baseline and 48hrs post 12-week training completion
Mean change from baseline and comparison between groups of self-perceived fitness after 12 weeks of training.
Time frame: Baseline and 48hrs post 12-week training completion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2024.
- Background: PubMed 17443211Sarafidis PA, Lasaridis AN, Nilsson PM, Pikilidou MI, Stafilas PC, Kanaki A, Kazakos K, Yovos J, Bakris GL. Validity and reproducibility of HOMA-IR, 1/HOMA-IR, QUICKI and McAuley's indices in patients with hypertension and type II diabetes. J Hum Hypertens. 2007 Sep;21(9):709-16. doi: 10.1038/sj.jhh.1002201. Epub 2007 Apr 19.
- Background: PubMed 3899825Matthews DR, Hosker JP, Rudenski AS, Naylor BA, Treacher DF, Turner RC. Homeostasis model assessment: insulin resistance and beta-cell function from fasting plasma glucose and insulin concentrations in man. Diabetologia. 1985 Jul;28(7):412-9. doi: 10.1007/BF00280883.
- Background: PubMed 21441238Ortega FB, Ruiz JR, Espana-Romero V, Vicente-Rodriguez G, Martinez-Gomez D, Manios Y, Beghin L, Molnar D, Widhalm K, Moreno LA, Sjostrom M, Castillo MJ; HELENA study group. The International Fitness Scale (IFIS): usefulness of self-reported fitness in youth. Int J Epidemiol. 2011 Jun;40(3):701-11. doi: 10.1093/ije/dyr039. Epub 2011 Mar 24.
- Background: PubMed 28476584Merellano-Navarro E, Collado-Mateo D, Garcia-Rubio J, Gusi N, Olivares PR. Validity of the International Fitness Scale "IFIS" in older adults. Exp Gerontol. 2017 Sep;95:77-81. doi: 10.1016/j.exger.2017.05.001. Epub 2017 May 2.
- Background: PubMed 24546008BALKE B, WARE RW. The present status of physical fitness in the Air Force. Proj Rep USAF Sch Aviat Med. 1959 May;59(67):1-9. No abstract available.
- Background: PubMed 19199208Astorino TA, White AC, Dalleck LC. Supramaximal testing to confirm attainment of VO2max in sedentary men and women. Int J Sports Med. 2009 Apr;30(4):279-84. doi: 10.1055/s-0028-1104588. Epub 2009 Feb 6.
- Background: PubMed 24886925Nolan PB, Beaven ML, Dalleck L. Comparison of intensities and rest periods for VO2max verification testing procedures. Int J Sports Med. 2014 Nov;35(12):1024-9. doi: 10.1055/s-0034-1367065. Epub 2014 Jun 2.
- Background: PubMed 27128112Weatherwax RM, Richardson TB, Beltz NM, Nolan PB, Dalleck L. Verification Testing to Confirm VO2max in Altitude-Residing, Endurance-Trained Runners. Int J Sports Med. 2016 Jun;37(7):525-30. doi: 10.1055/s-0035-1569346. Epub 2016 Apr 29.
- BackgroundKendzierski D and DeCarlo KJ. Physical activity enjoyment scale: Two validation studies. Journal of Sport and Exercise Psychology. 1991; 13:50-64.
- Background: PubMed 19397847Kwan BM, Bryan A. In-task and post-task affective response to exercise: translating exercise intentions into behaviour. Br J Health Psychol. 2010 Feb;15(Pt 1):115-31. doi: 10.1348/135910709X433267. Epub 2009 Apr 25.
- BackgroundHeinrich KM, Crawford DA, Johns BR, Frye J, and Gilmore KEO. Affective responses during high-intensity functional training compared to high-intensity interval training and moderate continuous training. Sport, Exercise, and Performance Psychology. 2019;9(1):115-127.
- Derived from this study: PubMed 35232475Smith LE, Van Guilder GP, Dalleck LC, Harris NK. The effects of high-intensity functional training on cardiometabolic risk factors and exercise enjoyment in men and women with metabolic syndrome: study protocol for a randomized, 12-week, dose-response trial. Trials. 2022 Mar 1;23(1):182. doi: 10.1186/s13063-022-06100-7.
- Individual participant dataSharing planned: Yes. De-identified IPD will be available upon request.
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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.
Lance C Dalleck, PhD principal investigator
Western Colorado University
Nigel Harris, PhD principal investigator
Auckland University of Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HIFT 1x/week, HIFT 2x/week and HIFT 3x/week in people with Metabolic Syndrome and Atherogenic Dyslipidemia, run by Gary Van Guilder 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 3 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: finished, as of the sponsor's last update on 23 Apr 2024. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Mean change from baseline and comparison between groups in apolipoprotein B (ApoB) count after 12 weeks of training. (time frame: Baseline and 48hrs post 12-week training completion). The study lists 14 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 NCT05001126, which also lists 12 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 23 Apr 2024.