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How exercise and a special ketone supplement may improve heart health, metabolism, and brain function

Effects of ketone supplementation and sprint interval training in normoia and hypoxia on cardiometabolic and neurocognitive outcomes in overweight/obese young adults

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN14786295
Enrollment
135
Registered
2025-12-03
Start date
2024-09-16
Completion date
Unknown
Last updated
2026-07-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Overweight or obesity Nutritional, Metabolic, Endocrine

Interventions

For study 1, it utilizes a randomized, counterbalanced, single-blinded crossover design comparing four conditions: non exercise control (CON), sprint interval training (SIT), exogenous ketone supplem

Sponsors

Faculty of Education, University of Macau
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 45 Years

Inclusion criteria

Inclusion criteria: For study 1 and 2 1. Aged 18-45 years old. 2. BMI= 23 kg/m² or percentage of body fat (PBF) = 30%, weight stability (±3 kg in past 6 months). 3. Altitude residence <1000 m, no prior hypoxic training, physically healthy. 4. Right-handed. Study 3 1. Aged 18-30 years old 2. phone use time = 2 hours/day 3. Right-handed

Exclusion criteria

Exclusion criteria: Study 1 and 2. 1. Structured training/ diets 2. Medication use (oral contraceptive or any medication intake) 3. Smoking/alcohol use 4. Exercise limitations 5. Medical conditions (endocrine, metabolic, cardiovascular respiratory issues) 6. Unable to provide the signed informed consent. 7. Any diseases within the past year Study 3. 1. Medication use (oral contraceptive or any medication intake) 2. Smoking/alcohol use 3. Exercise limitations 4. Medical conditions (endocrine, metabolic, cardiovascular respiratory issues) 5. Unable to provide the signed informed consent. 6. Any diseases within the past year 7. Structured exercise training

Design outcomes

Primary

MeasureTime frame
Study 1 1. Cognitive function is measured using Stroop Test, N-Back, and Delay Discounting Task at baseline and post-intervention 2. Perceived fatigue is measured using Rate of Perceived Exertion (RPE) at pre-exercise, during exercise, and post-exercise 3. Food motivation is measured using Food Craving Questionnaire-State (FCQ-S) at baseline and post-intervention 4. Prefrontal cortex activation patterns are measured using functional Near-Infrared Spectroscopy (fNIRS) during cognitive tasks at baseline and post-intervention 5. Blood glucose, lactate, and beta-hydroxybutyrate are measured using capillary blood sampling analyzed with portable biochemical analyzers at baseline, 45 minutes after the supplement, 60 minutes after the supplement, post-exercise, 1 hour post-exercise, and 2 hours post-exercise 6. Aerobic fitness level is measured using submaximal VO2 kinetics test with CORTEX METAMAX 3B at baseline, 1 hour post-exercise, 2 hours post-exercise, and 24 hours post-exercise 7. Intervention adherence is measured using blood beta-hydroxybutyrate and lactate concentrations via capillary blood sampling analyzed with portable biochemical analyzers at baseline, 45 minutes after the supplement, 60 minutes after the supplement, post-exercise, 1 hour post-exercise, and 2 hours post-exercise Study 2 8. Cardiorespiratory fitness is measured using graded exercise test on a cycle ergometer with metabolic cart and heart rate monitoring at baseline and post-intervention 9. Body composition is measured using Dual-energy X-ray absorptiometry (DXA) or bioelectrical impedance analysis (BIA) at baseline and post-intervention 10. Blood biomarkers of metabolism and appetite are measured using venous blood sampling analyzed via standard clinical chemistry assays at baseline and post-intervention 11. Cognitive function and prefrontal cortex activation patterns are measured using Stroop Test, N-Back, Delay Discounting Task, and fNIRS monitoring during cognitive tasks at basel

Secondary

MeasureTime frame
Study 1 1. Body composition distribution is measured using Dual-energy X-ray absorptiometry (DEXA) and anthropometric measurements at baseline 2. Side effects are measured using oral enquiry after supplementation and exercise sessions at after each intervention session 3. Appetite is measured using Food Craving Questionnaire-State (FCQ-S) at baseline and after intervention 4. Dietary behaviors are measured using 24-hour dietary recall, Three-Factor Eating Questionnaire, and Eating Behavior Scale at baseline and after intervention 5. Anxiety is measured using Generalized Anxiety Scale at baseline and after intervention 6. Ratings of perceived exertion (RPE) are measured using Borg Rating of Perceived Exertion Scale at before, during, and after each exercise session 7. Enjoyment is measured using Physical Activity Enjoyment Scale (PACES), Exercise Enjoyment Scale (EES), and Exercise-induced Feeling Inventory (EFI) at immediately after exercise sessions 8. Heart rate is measured using Polar heart rate monitor (Polar H10) at continuously during intervention sessions 9. Blood pressure is measured using automated sphygmomanometer at baseline, 45 minutes after the supplement, 60 minutes after the supplement, post-exercise, 1 hour post-exercise, and 2 hours post-exercise 10. Peripheral oxygen saturation (SpO2) is measured using pulse oximeter at during intervention sessions Study 2 11. Dietary compliance is measured using 3-day food diaries and 24-hour dietary recalls analyzed using the “bohejiankang (????)” app at one week before the intervention (lead-in period) as baseline and during the 4-week intervention (e.g., weekly) Study 3 12. Aerobic fitness is measured using maximal oxygen uptake test with Cortex MetaMax 3B metabolic cart during graded exercise test at baseline 13. Smartphone addiction is measured using proposed diagnostic criteria for smartphone addiction at baseline All studies 14. Background information is measured using oral enquiry including maj

Countries

China, Macao

Contacts

Public ContactJay Lee
405630519@qq.com+853 65336826

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Jul 23, 2026