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

NCT06022315 | Recruiting

• 1 other identifier: University of Glasgow
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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 .

Conditions

Gastrointestinal Hormones

Outcome Measures

Primary Outcomes (1)

• Gastrointestinal appetite hormones

  Plasma concentration (pg/ml) before and after intervention during experimental trials

  240 minutes through study completion

Secondary Outcomes (4)

• Total body water

  at baseline and after 3 hours

• subjective appetite

  240 minutes through study completion

• energy intake

  3 days before and after intervention

• Insulin

  240 minutes through study completion

Study Arms (2)

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.

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.

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

Interventions

caloric restrction high carbohydrate low fat diet with exercise training program COMBINATION_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.

restricted high carbohydrate low fat diet with exercise training program

caloric restrction high fat low carbohydrate diet with exercise training program COMBINATION_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.

restricted High fat low carbohydrate diet with exercise training program

Eligibility Criteria

• Age: 25 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Glasgow: lead

Study Sites (1)

Human Nutrition, College of Medicine, Veterinary and Life Science

Glasgow, G31 2ER, United Kingdom

RECRUITING

Study Officials

• Taibah Almesbehi

  University of Glasgow, New lister Building, Glasgow, Scotland, United kingdom, G31 2ER

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dr Dalia Malkova

CONTACT

01412018690; Dalia.Malkova@glasgow.ac.uk

Taibah Almesbehi

CONTACT

07454900691; t.almesbehi.1@research.gla.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Lecturer Human Nutrition School of Medicine, Dentistry and Nursing College of Medical, Veterinary & Life Sciences University of Glasgow

Study Record Dates

• First Submitted: July 30, 2023
• First Posted: September 1, 2023
• Study Start: September 3, 2023
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: April 18, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)