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Impact of Macronutrient Composition of Energy-restricted Diet and Exercise on Body Composition and Appetite Hormones.

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ClinicalTrials.gov Identifier: NCT06022315
Recruitment Status : Recruiting
First Posted : September 1, 2023
Last Update Posted : April 18, 2024
Sponsor:
Information provided by (Responsible Party):
Dr Dalia Malkova, University of Glasgow

Study Description
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Brief 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. 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 .

Condition or disease Intervention/treatment Phase
Gastrointestinal Hormones Combination Product: caloric restrction high carbohydrate low fat diet with exercise training program Combination Product: caloric restrction high fat low carbohydrate diet with exercise training program Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
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
Actual Study Start Date : September 3, 2023
Estimated Primary Completion Date : December 2024
Estimated Study Completion Date : December 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hormones

Arms and Interventions
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Arm Intervention/treatment
Experimental: 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.
 Combination Product: 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.
Experimental: 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.
 Combination Product: 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.


Outcome Measures
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Primary Outcome Measures :
  1. Gastrointestinal appetite hormones [ Time Frame: 240 minutes through study completion ]
    Plasma concentration (pg/ml) before and after intervention during experimental trials


Secondary Outcome Measures :
  1. Total body water [ Time Frame: at baseline and after 3 hours ]
    Saliva sample (ml) before and after 3 hours of drinking D2O water during experimental trials

  2. subjective appetite [ Time Frame: 240 minutes through study completion ]
    Assess via visual analogue scale (100mm)

  3. energy intake [ Time Frame: 3 days before and after intervention ]
    Energy intake (Kcal) during intervention

  4. Insulin [ Time Frame: 240 minutes through study completion ]
    Plasma concentration (mU/L)before and after intervention during experimental trials


Eligibility Criteria
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Ages Eligible for Study:   25 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy Female
  • BMI of ≥25.0 kg/m2.
  • stable body weight for at least three months preceding the study

Exclusion Criteria:

  • 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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06022315


Contacts
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Contact: Dr Dalia Malkova 01412018690 Dalia.Malkova@glasgow.ac.uk
Contact: Taibah Almesbehi 07454900691 t.almesbehi.1@research.gla.ac.uk

Locations
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United Kingdom
Human Nutrition, College of Medicine, Veterinary and Life Science Recruiting
Glasgow, United Kingdom, G31 2ER
Contact: Dalia Malkova, PhD    +442523018690    Dalia.Malkova@glasgow.ac.ul   
Contact: Taibah Almesbehi, Msc    +441412018694    t.almesbehi.1@research.glasgow.ac.uk   
Sponsors and Collaborators
University of Glasgow
Investigators
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Principal Investigator: Taibah Almesbehi University of Glasgow, New lister Building, Glasgow, Scotland, United kingdom, G31 2ER
More Information
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Responsible Party: Dr Dalia Malkova, Senior Lecturer Human Nutrition School of Medicine, Dentistry and Nursing College of Medical, Veterinary & Life Sciences University of Glasgow, University of Glasgow
ClinicalTrials.gov Identifier: NCT06022315    
Other Study ID Numbers: University of Glasgow
First Posted: September 1, 2023    Key Record Dates
Last Update Posted: April 18, 2024
Last Verified: April 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: The study will published in scientific journal upon finished

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No