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

NCT05730231 | Completed

• 1 other identifier: TRE_Clinical
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

time-restricted eating; calorie restriction; metabolic syndrome; overweight and obesity; dietary strategy

Outcome Measures

Primary Outcomes (1)

• Change in Body Weight

  Changes in body weight (in kilograms) from baseline to week twelve measured with bioelectrical impedance analysis (BIA) Tanita MC-980MA

  three months

Secondary Outcomes (11)

• Change in Body Fat

  three months

• Changes in Visceral Fat Rating

  three months

• Changes in Muscle mass

  three months

• LDL Cholesterol

  three months

• Inflammation

  three months

Study Arms (3)

Early time-restricted eating with calorie restriction

EXPERIMENTAL

Participants will follow calorie restriction with early day time-restricted eating protocol with three planned meals from 8:00 AM to 4:00 PM.

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

Mid-day time-restricted eating with calorie restriction

EXPERIMENTAL

Participants will follow calorie restriction with mid-day time-restricted eating protocol with three planned meals from 1:00 PM to 9:00 PM.

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

Daily calorie restriction

EXPERIMENTAL

Participants will follow daily calorie restriction protocol with three planned meals from 8:00 AM to 9:00 PM.

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

Interventions

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

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/.

Daily calorie restriction; Early time-restricted eating with calorie restriction; Mid-day time-restricted eating with calorie restriction

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• BMI 25-35 kg/m2
• \+ one of the following criteria:
• Increased waist circumference ≥ 94 cm in men and ≥ 80 cm in women
• Fasting plasma glucose \> 5,6 mmol/L
• Elevated fasting plasma triglycerides 1,7 mmol/l
• Reduced high-density lipoprotein (HDL)-cholesterol \< 1,0 mmol/l for men, \< 1,3 mmol/l for women
• Elevated blood pressure, systolic blood pressure \> 130 mm Hg and diastolic blood pressure \> 85 mm Hg
• Without medicals for hypertension and hypercholesterolemia
• Morning or afternoon working time

You may not qualify if:

• Pregnant or plan to be become pregnant
• Lactating women
• Active smoking
• Diagnosis of diabetes
• Eating disorders
• Currently enrolled in a weight-management program
• Uncontrolled medical condition due to gastrointestinal, psychiatric, rheumatologic, oncologic, hematologic or endocrine diseases
• History of tumor
• History of serious cardiovascular or cerebrovascular diseases
• Taking medicines that may affect weight and appetite

Sponsors & Collaborators

• University of Primorska: lead

Study Sites (1)

University of Primorska, Faculty of Health Sciences

Izola, 6310, Slovenia

Location

Related Publications (5)

• Manoogian ENC, Chow LS, Taub PR, Laferrere B, Panda S. Time-restricted Eating for the Prevention and Management of Metabolic Diseases. Endocr Rev. 2022 Mar 9;43(2):405-436. doi: 10.1210/endrev/bnab027.

  PMID: 34550357 BACKGROUND

• Liu D, Huang Y, Huang C, Yang S, Wei X, Zhang P, Guo D, Lin J, Xu B, Li C, He H, He J, Liu S, Shi L, Xue Y, Zhang H. Calorie Restriction with or without Time-Restricted Eating in Weight Loss. N Engl J Med. 2022 Apr 21;386(16):1495-1504. doi: 10.1056/NEJMoa2114833.

  PMID: 35443107 BACKGROUND

• Swiatkiewicz I, Mila-Kierzenkowska C, Wozniak A, Szewczyk-Golec K, Nuszkiewicz J, Wroblewska J, Rajewski P, Eussen SJPM, Faerch K, Manoogian ENC, Panda S, Taub PR. Pilot Clinical Trial of Time-Restricted Eating in Patients with Metabolic Syndrome. Nutrients. 2021 Jan 24;13(2):346. doi: 10.3390/nu13020346.

  PMID: 33498955 BACKGROUND

• Zhang LM, Liu Z, Wang JQ, Li RQ, Ren JY, Gao X, Lv SS, Liang LY, Zhang F, Yin BW, Sun Y, Tian H, Zhu HC, Zhou YT, Ma YX. Randomized controlled trial for time-restricted eating in overweight and obese young adults. iScience. 2022 Aug 5;25(9):104870. doi: 10.1016/j.isci.2022.104870. eCollection 2022 Sep 16.

  PMID: 36034217 BACKGROUND

• Cresnovar T, Habe B, Mohorko N, Kenig S, Jenko Praznikar Z, Petelin A. Early time-restricted eating with energy restriction has a better effect on body fat mass, diastolic blood pressure, metabolic age and fasting glucose compared to late time-restricted eating with energy restriction and/or energy restriction alone: A 3-month randomized clinical trial. Clin Nutr. 2025 Jun;49:57-68. doi: 10.1016/j.clnu.2025.04.001. Epub 2025 Apr 8.

  PMID: 40250088 DERIVED

MeSH Terms

Conditions

Intermittent Fasting; Overweight; Obesity; Inflammation; Hypercholesterolemia; Hypertension; Hyperglycemia; Metabolic Syndrome; Communicable Diseases

Condition Hierarchy (Ancestors)

Fasting; Feeding Behavior; Behavior; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pathologic Processes; Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Vascular Diseases; Cardiovascular Diseases; Glucose Metabolism Disorders; Insulin Resistance; Hyperinsulinism; Infections; Disease Attributes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: February 6, 2023
• First Posted: February 15, 2023
• Study Start: March 3, 2023
• Primary Completion: June 30, 2023
• Study Completion: June 30, 2024
• Last Updated: March 5, 2025

Record last verified: 2024-08

Locations

SL (1)