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

University of Glasgow

Status: Enrolling

Conditions: Gastrointestinal Hormones

Treatments: 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

Study type: Interventional

Funder types: Other

Identifiers

NCT06022315

University of Glasgow

Details and patient eligibility

About

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 .

Full 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.

Enrollment: 40 estimated patients

Sex: Female

Ages: 25 to 45 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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40 participants in 2 patient groups

restricted high carbohydrate low fat diet with exercise training program

Experimental group

Description:

exercise training combined with the consumption of caloric restricted high CHO-low FAT diet. The interventions will last for four weeks.

Treatment:

Combination Product: caloric restrction high carbohydrate low fat diet with exercise training program

restricted High fat low carbohydrate diet with exercise training program

Experimental group

Description:

exercise training with consumption of caloric restricted low CHO-high FAT diet. The interventions will last for four weeks.

Treatment:

Combination Product: caloric restrction high fat low carbohydrate diet with exercise training program