Clinical trial
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
Name
University of Glasgow
Description
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 .
Trial arms
Trial start
2023-09-03
Estimated PCD
2024-12-01
Trial end
2024-12-01
Status
Recruiting
Treatment
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.
Arms:
restricted high carbohydrate low fat diet with exercise training program
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.
Arms:
restricted High fat low carbohydrate diet with exercise training program
Size
40
Primary endpoint
Gastrointestinal appetite hormones
240 minutes through study completion
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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}}, 'enrollmentInfo': {'count': 40, 'type': 'ESTIMATED'}}
Updated at
2024-04-18
1 organization
2 products
1 indication
Organization
University of GlasgowIndication
gastrointestinal hormones