Could a Time-restricted Diet Compete With a Calorie-restricted 6-meal Diet?

NCT06364475 | Completed

• 1 other identifier: BezmialemVU-TF-AÖ-1
• Study Type: interventional
• Target: 137
• Locations: 1 country
• Sites: 1

Brief Summary

The prevalence of obesity and obesity-related diseases are on the rise worldwide. The widely accepted approach in dietary treatment of obesity is the calorie-restricted three meals-three snacks a day diet; however, alternative approaches are needed. This study was conceived with a view to comparing time-restricted eating, a method which can be easily conveyed and applied in overcoming obesity, to a six meals a day diet. 174 participants aged between 18-65 with a BMI\>25 kg/m2 were included. Diet lists with similar calorie, macro counts suitable for their respective group were prepared. Anthropometric measurements, blood pressure, blood tests were analyzed before the study and at the end of the 8-week.

Conditions

Overweight and Obesity

Keywords

Obesity; Nutrition Therapy; Weight Loss; Intermittent Fasting

Outcome Measures

Primary Outcomes (1)

• Weight measured in kilogram

  It contains weight measured in kilogram. This was measured with Tanita Compacto CS 601 which one 0.1 kg sensitive scale.

  Two months

Secondary Outcomes (4)

• Body composition

  Two months

• Body mass index

  Two months

• Waist-to-height ratio (WHtR)

  Two months

• Waist circumference in centimetres

  Two months

Study Arms (2)

16:8 Time-Restricted Intermittent Fasting Group

ACTIVE COMPARATOR

88 people were included in the 16:8 time-restricted intermittent fasting group with an 8-hour window for food consumption, with an eating plan of 400 kcal lower than the total daily energy requirement.

Behavioral: 16:8 Time-Restricted Intermittent Fasting Group

Energy-Restricted Six-Meal Group

ACTIVE COMPARATOR

86 people were included in the energy-restricted six-meal group. This group have an eating plan three meal and three snack of 400 kcal lower than the total daily energy requirement.

Behavioral: Energy-Restricted Six-Meal Group

Interventions

16:8 Time-Restricted Intermittent Fasting Group BEHAVIORAL

Participants total daily energy expenditures were calculated using the Harris-Benedict formula. This group have a feeding window 8 hours and eating plan of 400 kcal lower than the total daily energy requirement and with similar macronutrient content (50% carbohydrates, 25% fat and 25% protein). Participants in the time-restricted eating group were allowed to drink calorie-free. They were expected to follow their diet for two months during the study.

16:8 Time-Restricted Intermittent Fasting Group

Energy-Restricted Six-Meal Group BEHAVIORAL

Participants total daily energy expenditures were calculated using the Harris-Benedict formula. This group have an eating plan three meals and three snacks of 400 kcal lower than the total daily energy requirement and with similar macronutrient content (50% carbohydrates, 25% fat and 25% protein). They were expected to follow their diet for two months during the study.

Energy-Restricted Six-Meal Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged between 18-65
• BMI \>25 kg/m2

You may not qualify if:

• People with a history of bariatric surgery
• Eating disorders
• Alcohol and drug addiction
• Anti-obesity medication use
• Diagnosed with diabetes and hypothyroidism
• Active cancer patients
• People carrying infectious diseases

Sponsors & Collaborators

• Bezmialem Vakif University: lead

Study Sites (1)

İstanbul Sabri Artam Vakfi Family Medicine Center

Istanbul, 34473, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Overweight; Obesity; Weight Loss; Intermittent Fasting

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Weight Changes; Fasting; Feeding Behavior; Behavior

Study Officials

• Aclan Ozder, Prof

  Bezmialem Vakif University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: One group 16:8 time-restricted intermittent fasting and the other group energy-restricted six-meal eating. Both of groups with an eating plan suitable with their groups and 400 kcal lower than the total daily energy requirement and with similar macronutrient content (50% carbohydrates, 25% fat and 25% protein).

Study Record Dates

• First Submitted: April 4, 2024
• First Posted: April 15, 2024
• Study Start: November 1, 2021
• Primary Completion: July 1, 2022
• Study Completion: September 1, 2022
• Last Updated: April 15, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)