Clinical Trials of Effects of Time Restricted Eating on Health Parameters in Adults

Summary

In a randomized controlled trial we will research the effect of calorie restriction with early and mid-day time-restricted eating (TRE) and daily calorie restriction on weight loss and human health parameters. Participants will be divided into three groups: early time-restriction group (8:00 AM to 4:00 PM), mid-day restriction group (1:00 PM to 9:00 PM) and daily calorie restriction group (8:00 AM to 9:00 PM). Participants will follow dietary strategy with three planned meals and calorie restriction. Anthropometrical and biochemical parameters will be measured at baseline, after one month, two months and at after three months of intervention. Resting metabolic rate, ultrasound scan of abdomen and ultrasound scan of carotid arteries will be measured at baseline and after three months of intervention. In addition, stool samples will be also taken at baseline and after three months of intervention.

Conditions

• Time Restricted Feeding
• Overweight and Obesity
• Inflammation
• Hypercholesterolemia
• Hypertension
• Hyperglycemia
• Antioxidative Stress
• Metabolic Syndrome
• Microbial Colonization

Interventions

OTHER

Effects of calorie restriction and time-restricted eating on human health

Calorie restriction plan will be prepared for each participant. After nutritional data collection at baseline, all participant will attend educational sessions about healthy diet and beneficial effects of time-restricted eating. To estimate total energy needs, individuals' RMR will be measured from indirect calorimeter and multiplied by the appropriate factor of physical activity (from 1.3 to 1.6), and then a reduction of 200-500 kcal will be made. Macronutrient composition of the diet will be approximately 45-55% of carbohydrate, 30-35% of fat, and 15-20% of protein. 30% of daily energy intake will be consumed by breakfast, 40% by lunch and 30% by dinner. During posting participants will be allowed to consume only water and herbal infusions without added sugars or sweeteners. Dietary intake of participants will be followed during the study using a 24-h recall. Dietary data will be analysed using the Open Platform for Clinical Nutrition accessible through the website http://opkp.si/.

Sponsors & Collaborators

• University of Primorska

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

60 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2023-03-03

Primary Completion

2023-06-30

Completion

2024-06-30

Countries

• Slovenia

Study Locations