Impact of Macronutrient Composition of Energy-restricted Diet and Exercise on Body Composition and Appetite Hormones.
NCT ID: NCT06022315
Last Updated: 2024-04-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
NA
40 participants
INTERVENTIONAL
2023-09-03
2024-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Effect of Exercise on Appetite in Response to Meals During Energy Restriction
NCT06895837
Composition of Meals Around Exercise Session
NCT04249609
Effect of Exercise on Appetite in Response to Meals
NCT06096233
Effects of Pre-exercise Carbohydrate Restriction Relative to Fasting on Metabolism, Appetite, and Energy Intake in Healthy Males.
NCT05107583
Effects of Weight Loss on Nutritional Mediated Hormone Secretion
NCT02649907
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Prior to the first experimental trial, participants will be subjected to a screening process followed by a preliminary exercise test in the metabolic research unit at New Lister Building (NLB), Glasgow Royal infirmary (GRI). Participants will also be asked to record their food and drink consumed for 4 days (3 weekdays and 1 weekend) prior to and during the four last days of the intervention. By following this step, individual diets will be designed based on participants preferences with restricted energy intake and different macronutrient compositions. Dietary intake records will allow a comparison of participants' calorie intake before and after the intervention.
During intervention participants will consume either energy-restricted low CHO-high FAT or energy-restricted high CHO-Low FAT diet and exercise (brisk walking) while wearing a heart rate monitor 3 times a week after 5 minutes of warm-up, and 5 minutes The duration of the brisk walking will increase after week one from 30 to 45 minutes and to 60 minutes at week three and four. Participants will be advised to cool down after the brisk walking session. During the intervention, participants will be encouraged to avoid alcohol consumption. In case this was not possible, a maximum amount of two units will be allowed per week.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
restricted high carbohydrate low fat diet with exercise training program
exercise training combined with the consumption of caloric restricted high CHO-low FAT diet. The interventions will last for four weeks.
caloric restrction high carbohydrate low fat diet with exercise training program
Subjects will perform 3 sessions/week of brisk walking for four weeks at a heart rate corresponding to 85-90% of the lactate threshold. The duration of exercise sessions will increase from 30 minutes to 45 minutes in week 2 and from 45 minutes to 60 minutes in weeks 3 and 4.
Experimental diets will be calorie-restricted and provide 70% of estimated daily energy requirements. In the high CHO-low FAT diet, carbohydrates, fat, and protein will provide 60%, 25%, and 15% of individually predicted daily energy intake, respectively. Variety (n=7) of daily menus for calorie-restricted high FAT-low CHO diet will be provided and menus for high CHO-low FAT diet on pasta, rice, oats, fruit, and vegetable.During the intervention, participants will be encouraged to avoid alcohol consumption and only the maximum amount of two units will be allowed per week.
restricted High fat low carbohydrate diet with exercise training program
exercise training with consumption of caloric restricted low CHO-high FAT diet. The interventions will last for four weeks.
caloric restrction high fat low carbohydrate diet with exercise training program
Subjects will perform 3 sessions/week of brisk walking for four weeks at a heart rate corresponding to 85-90% of the lactate threshold.The duration of exercise sessions will increase from 30 minutes to 45 minutes in week 2 and from 45 minutes to 60 minutes in weeks 3 and 4.
Experimental diets will be calorie-restricted and provide 70% of estimated daily energy requirements. In the low CHO-high FAT diet, the proportion of energy provided by CHO, fat, and protein will consist of 25%, 60%, and 15%, respectively. Variety (n=7) of daily menus for calorie-restricted low CHO-high FAT diet will be provided and menus for high FAT-low CHO group will be based on meat, fish, cheese, butter, and nuts.During the intervention, participants will be encouraged to avoid alcohol consumption and only the maximum amount of two units will be allowed per week.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
caloric restrction high carbohydrate low fat diet with exercise training program
Subjects will perform 3 sessions/week of brisk walking for four weeks at a heart rate corresponding to 85-90% of the lactate threshold. The duration of exercise sessions will increase from 30 minutes to 45 minutes in week 2 and from 45 minutes to 60 minutes in weeks 3 and 4.
Experimental diets will be calorie-restricted and provide 70% of estimated daily energy requirements. In the high CHO-low FAT diet, carbohydrates, fat, and protein will provide 60%, 25%, and 15% of individually predicted daily energy intake, respectively. Variety (n=7) of daily menus for calorie-restricted high FAT-low CHO diet will be provided and menus for high CHO-low FAT diet on pasta, rice, oats, fruit, and vegetable.During the intervention, participants will be encouraged to avoid alcohol consumption and only the maximum amount of two units will be allowed per week.
caloric restrction high fat low carbohydrate diet with exercise training program
Subjects will perform 3 sessions/week of brisk walking for four weeks at a heart rate corresponding to 85-90% of the lactate threshold.The duration of exercise sessions will increase from 30 minutes to 45 minutes in week 2 and from 45 minutes to 60 minutes in weeks 3 and 4.
Experimental diets will be calorie-restricted and provide 70% of estimated daily energy requirements. In the low CHO-high FAT diet, the proportion of energy provided by CHO, fat, and protein will consist of 25%, 60%, and 15%, respectively. Variety (n=7) of daily menus for calorie-restricted low CHO-high FAT diet will be provided and menus for high FAT-low CHO group will be based on meat, fish, cheese, butter, and nuts.During the intervention, participants will be encouraged to avoid alcohol consumption and only the maximum amount of two units will be allowed per week.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* BMI of ≥25.0 kg/m2.
* stable body weight for at least three months preceding the study
Exclusion Criteria
* irregular menstruation cycle,
* use any type of medication,
* exercising more than 75min a week,
* are pregnant or lactating.
* on any dietary supplements at the time of the study,
* are vegetarian or are following any diet other than the typical Western diet.
25 Years
45 Years
FEMALE
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University of Glasgow
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Dr Dalia Malkova
Senior Lecturer Human Nutrition School of Medicine, Dentistry and Nursing College of Medical, Veterinary & Life Sciences University of Glasgow
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Taibah Almesbehi
Role: PRINCIPAL_INVESTIGATOR
University of Glasgow, New lister Building, Glasgow, Scotland, United kingdom, G31 2ER
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Human Nutrition, College of Medicine, Veterinary and Life Science
Glasgow, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
University of Glasgow
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.