Gastrointestinal HormonesNCT06022315
Impact of Macronutrient Composition of Energy-restricted Diet and Exercise on Body Composition and Appetite Hormones.
A study testing caloric restrction high carbohydrate low fat diet with exercise training program and caloric restrction high fat low carbohydrate diet with exercise training program in people with Gastrointestinal Hormones, run by University of Glasgow at 1 site in United Kingdom.
Trial summary
The main aim of this study is to investigate the effect of energy-restricted low and high-carbohydrate diet combined with exercise training on appetite regulatory hormones, subjective appetite and energy intake in overweight and obese women. Read more about this study
- Who is it for?
- Ages 25 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Gastrointestinal Hormones
- What is being tested?
- caloric restrction high carbohydrate low fat diet with exercise training program and caloric restrction high fat low carbohydrate diet with exercise training program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 3 Sep 2023to Dec 2024
- 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 25 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy Female
- BMI of ≥25.0 kg/m2.
- stable body weight for at least three months preceding the study
Who cannot join
- smokers and have
- 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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Human Nutrition, College of Medicine, Veterinary and Life Science
Glasgow, G31 2ER
Dalia Malkova, PhD, +442523018690, Dalia.Malkova@glasgow.ac.ul
Taibah Almesbehi, Msc, +441412018694, t.almesbehi.1@research.glasgow.ac.uk
About this study
Official title: Role of Gastrointestinal Appetite Hormones in the Success of Body Mass Loss Interventions Based on Exercise Combined With Calorie-restricted Diets With Different Fat and Carbohydrate Content
The main aim of this study is to investigate the effect of energy-restricted low and high-carbohydrate diet combined with exercise training on appetite regulatory hormones, subjective appetite and energy intake in overweight and obese women. In addition, since the macronutrient composition of meals and exercise impacts biomarkers of cardiovascular disease, the impact of these interactions on metabolic risk factors of cardiovascular diseases will also be investigated .
Read the detailed description
This will be a block randomised parallel study, with one group of participants undergoing exercise training combined with the consumption of a calorie-restricted high CHO-low FAT diet and another group undergoing exercise training with consumption of a calorie-restricted low CHO-high FAT diet. The interventions will last for 4 weeks. Prior to and after the interventions participants will undergo a 5-hour experimental trial, which will involve body composition measurements by the D2O method, appetite hormones, insulin via blood collection and subjective appetite via a visual analogue scale. During the experimental trials, participants will consume breakfast and ad libitum buffet-style lunch.
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
- Gastrointestinal Hormones
- Being tested
- caloric restrction high carbohydrate low fat diet with exercise training program, caloric restrction high fat low carbohydrate diet with exercise training program
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
caloric restrction high carbohydrate low fat diet with exercise training programCombination product
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 programCombination product
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.
| Study group | Role | What they receive |
|---|---|---|
| restricted high carbohydrate low fat diet with exercise training program | Experimental | exercise training combined with the consumption of caloric restricted high CHO-low FAT diet. The interventions will last for four weeks. Receives: Combination Product: caloric restrction high carbohydrate low fat diet with exercise training program |
| restricted High fat low carbohydrate diet with exercise training program | Experimental | exercise training with consumption of caloric restricted low CHO-high FAT diet. The interventions will last for four weeks. Receives: Combination Product: caloric restrction high fat low carbohydrate diet with exercise training program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gastrointestinal appetite hormones
Plasma concentration (pg/ml) before and after intervention during experimental trials
Measured: 240 minutes through study completion
Secondary outcomes (4)
Total body water
Saliva sample (ml) before and after 3 hours of drinking D2O water during experimental trials
Measured: at baseline and after 3 hours
subjective appetite
Assess via visual analogue scale (100mm)
Measured: 240 minutes through study completion
energy intake
Energy intake (Kcal) during intervention
Measured: 3 days before and after intervention
Insulin
Plasma concentration (mU/L)before and after intervention during experimental trials
Measured: 240 minutes through study completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2023
- Study start3 Sep 2023
- Primary completionDec 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastrointestinal HormonesStudies 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Glasgow
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Dalia Malkova, University of Glasgow
- Investigators
- Taibah Almesbehi, Principal investigator, University of Glasgow, New lister Building, Glasgow, Scotland, United kingdom, G31 2ER
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06022315
- Sponsor's protocol ID
- University of Glasgow
- Status last verified
- Apr 2024
- First submitted
- 30 Jul 2023
- Last updated
- 18 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The study will published in scientific journal upon finished
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Gastrointestinal Appetite Hormones in the Success of Body Mass Loss Interventions Based on Exercise Combined With Calorie-restricted Diets With Different Fat and Carbohydrate Content
- ClinicalTrials.gov ID
- NCT06022315
- Acronym / sponsor ID
- University of Glasgow
- Conditions
- Gastrointestinal Hormones
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of GlasgowUniversity, hospital or other
- Study start
- 3 Sep 2023 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 1 Sep 2023 (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.
The main aim of this study is to investigate the effect of energy-restricted low and high-carbohydrate diet combined with exercise training on appetite regulatory hormones, subjective appetite and energy intake in overweight and obese women. In addition, since the macronutrient composition of meals and exercise impacts biomarkers of cardiovascular disease, the impact of these interactions on metabolic risk factors of cardiovascular diseases will also be investigated .
Detailed description
This will be a block randomised parallel study, with one group of participants undergoing exercise training combined with the consumption of a calorie-restricted high CHO-low FAT diet and another group undergoing exercise training with consumption of a calorie-restricted low CHO-high FAT diet. The interventions will last for 4 weeks. Prior to and after the interventions participants will undergo a 5-hour experimental trial, which will involve body composition measurements by the D2O method, appetite hormones, insulin via blood collection and subjective appetite via a visual analogue scale. During the experimental trials, participants will consume breakfast and ad libitum buffet-style lunch.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| restricted high carbohydrate low fat diet with exercise training program | Experimental | Combination Product: caloric restrction high carbohydrate low fat diet with exercise training programexercise training combined with the consumption of caloric restricted high CHO-low FAT diet. The interventions will last for four weeks. |
| restricted High fat low carbohydrate diet with exercise training program | Experimental | Combination Product: caloric restrction high fat low carbohydrate diet with exercise training programexercise training with consumption of caloric restricted low CHO-high FAT diet. The interventions will last for four weeks. |
Who may qualify
- Ages
- 25 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy Female
- BMI of ≥25.0 kg/m2.
- stable body weight for at least three months preceding the study
Key exclusion criteria (7 listed)
- smokers and have
- irregular menstruation cycle,
- use any type of medication,
- exercising more than 75min a week,
- are pregnant or lactating.
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 |
|---|---|---|
| caloric restrction high carbohydrate low fat diet with exercise training programSubjects 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. | Combination product | restricted high carbohydrate low fat diet with exercise training program |
| caloric restrction high fat low carbohydrate diet with exercise training programSubjects 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. | Combination product | restricted High fat low carbohydrate diet with exercise training program |
Primary outcome
Gastrointestinal appetite hormones
Time frame: 240 minutes through study completion
Plasma concentration (pg/ml) before and after intervention during experimental trials
4 secondary outcomes
Total body water
Time frame: at baseline and after 3 hours
subjective appetite
Time frame: 240 minutes through study completion
energy intake
Time frame: 3 days before and after intervention
Insulin
Time frame: 240 minutes through study completion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2024.
- Individual participant dataSharing planned: No. The study will published in scientific journal upon finished
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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.
Taibah Almesbehi principal investigator
University of Glasgow, New lister Building, Glasgow, Scotland, United kingdom, G31 2ER
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing caloric restrction high carbohydrate low fat diet with exercise training program and caloric restrction high fat low carbohydrate diet with exercise training program in people with Gastrointestinal Hormones, run by University of Glasgow at 1 site in United Kingdom.
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 3 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 18 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 Kingdom. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dr Dalia Malkova (01412018690, Dalia.Malkova@glasgow.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gastrointestinal appetite hormones (time frame: 240 minutes through study completion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Apr 2024.