Clinical trial NCT06022315: Impact of Macronutrient Composition of Energy-restricted Diet and Exercise on Body Composition and Appetite Hormones.
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Gastrointestinal Hormones
Lead sponsor: University of Glasgow
Sponsor class: OTHER
First posted: 2023-09-01
Enrollment: 40
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 .

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.

Eligibility 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.

Primary outcomes:
measure: Gastrointestinal appetite hormones
timeFrame: 240 minutes through study completion
Secondary outcomes:
measure: Total body water
timeFrame: at baseline and after 3 hours
measure: subjective appetite
timeFrame: 240 minutes through study completion
measure: energy intake
timeFrame: 3 days before and after intervention
measure: Insulin
timeFrame: 240 minutes through study completion
Other outcomes:
Locations:
city: Glasgow
country: United Kingdom
facility: Human Nutrition, College of Medicine, Veterinary and Life Science
Study officials:
affiliation: University of Glasgow, New lister Building, Glasgow, Scotland, United kingdom, G31 2ER
name: Taibah Almesbehi
role: PRINCIPAL_INVESTIGATOR
References: