Time-Restricted Feeding on Cardiovascular Health Effects

NCT06420466 | Completed

• 1 other identifier: KY-2022-101-01
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Study Design and Participants This intervention study was conducted as a randomized controlled trial (RCT) aimed at investigating the effects of time-restricted feeding (TRF) on cardiovascular health markers among overweight male university students in Shenzhen, China. The study recruited male university students aged between 18 and 24 years, with a Body Mass Index (BMI) ranging from 24 to less than 28. All participants were free from severe psychiatric illnesses, metabolic syndrome, diabetes, alcoholic fatty liver disease, hyperthyroidism, or hypothyroidism. Inclusion criteria required participants to be non-smokers, not currently on any diet pills, and have no history of cardiovascular or metabolic diseases. Randomization and Intervention Fifty eligible participants were randomly assigned to either the intervention group (n=25) or the control group (n=25). The intervention group underwent a 6-hour daily TRF from noon to 6 P.M., while the control group did not participate in TRF but maintained their usual eating patterns. No restrictions were placed on the type or quantity of food consumed by participants in either group. Data Collection and Measures Body Composition and Anthropometry: Measurements included body mass index, body fat percentage, muscle mass, hydration levels, protein content, and visceral fat, all assessed using a bioelectrical impedance analysis scale (Mi Body Composition Scale 2 by Huami Technology). Waist circumference was manually measured by experienced nurses using a tape measure. Blood Pressure and Heart Rate: These vital signs were monitored using an arm cuff electronic blood pressure monitor (Panasonic EW3153), with the arm positioned at heart level to ensure accuracy. Measurements were taken after at least five minutes of seated rest. Nutritional Intake Although time-restricted feeding interventions do not usually change the content or quantity of dietary intake, the total daily intakes of energy, fat, protein, carbohydrate, cholesterol, and fibre were calculated using the Nutritionist Pro food analysis program. This was used to determine possible changes in the subjects' dietary composition as a result of the intervention. Compliance and Ethical Considerations The study protocol was approved by the Ethics Committee of the Seventh Affiliated Hospital of Sun Yat-sen University (Shenzhen), with the approval number KY-2022-101-01. All data were handled confidentially, and measures were taken to ensure high adherence and minimal loss to follow-up. Statistical Analysis Descriptive statistics such as range, mean, standard deviation, and percentages were used to describe the sample characteristics. To compare differences, the change from baseline levels was assessed to account for initial variability, employing an independent samples t-test for the analysis.

Conditions

Time Restricted Feeding; Cardiovascular Health; Body Composition; Blood Pressure; Young Adult

Outcome Measures

Primary Outcomes (4)

• Body Mass Index (BMI)

  BMI is calculated using a standardized ratio of weight to height (kg/m²), offering a quantitative measure of body composition. This outcome will be assessed using digital scales for accurate weight measurement and stadiometers for height, ensuring precise BMI calculation.

  4 Weeks

• Waist Circumference

  Waist circumference is measured using a flexible measuring tape, which allows for a direct quantification of visceral fat accumulation. This measure provides critical insights into metabolic health risks, differentiating it from BMI by focusing specifically on central obesity.

  4 Weeks

• Blood pressure

  Revised Description: Blood pressure will be measured using a standardized sphygmomanometer, ensuring consistent and reproducible results. This tool will help monitor changes in systolic and diastolic blood pressure, which are vital for evaluating the effects of time-restricted eating on cardiovascular health.

  4 Weeks

• Nutritional indicators

  Nutritional indicators will be assessed through detailed 24-hour dietary recall interviews and food diaries analyzed using nutritional analysis software. This approach will quantify changes in nutrient intake, highlighting the dietary impact of time-restricted feeding interventions.

  4 Weeks

Study Arms (2)

Time-restricted Feeding group

EXPERIMENTAL

Controlling the eating time to 6 hours per day, but not being prescriptive about the quantity and content of dietary intake.

Behavioral: Time-restricted Feeding

Control group

NO INTERVENTION

Interventions

Time-restricted Feeding BEHAVIORAL

Controlling the eating time to 6 hours per day, but not being prescriptive about the quantity and content of dietary intake.

Time-restricted Feeding group

Eligibility Criteria

• Age: 18 Years - 24 Years
• Gender Eligibility Details: A single physiological group of others was chosen for the study because dietary habits and physiological indicators may differ between genders.
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Subjects were able to provide signed and dated written informed consent.
• Subjects are male undergraduates aged 18-24 years old.
• BMI between 24 and 28.
• Normal sleep duration, usually between 7-9 hours per day.
• Stable sleep habits, typically going to bed around midnight (±1 hour).

You may not qualify if:

• Inability to comply with the time-limited diet plan.
• Experiencing hypoglycemic reactions during the time-limited diet program.
• Presence of metabolic diseases such as diabetes.
• Participation in high-intensity physical training for more than 5 hours per week.
• Extreme chronotypes, as indicated by scores ≤30 or ≥70 on the Morning and Evening Questionnaire Self-Assessment Scales (MEQ-SA).
• Severe weight instability, defined as weight gain or loss of more than 5 kg in the 3 months prior to the study.
• Severe food allergy or intolerance.
• Participation in another medical study within 6 months prior to the first study visit.

Sponsors & Collaborators

• Zhengqi Qiu: lead
• The Seventh Affiliated Hospital of Sun Yat-sen University: collaborator
• Shenzhen University: collaborator

Study Sites (1)

Shenzhen university

Shenzhen, Guangdong, 518000, China

Location

MeSH Terms

Conditions

Intermittent Fasting

Condition Hierarchy (Ancestors)

Fasting; Feeding Behavior; Behavior

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: SPONSOR INVESTIGATOR
• PI Title: Associate researcher

Model Details: Randomized Controlled Trial

Study Record Dates

• First Submitted: May 4, 2024
• First Posted: May 20, 2024
• Study Start: February 1, 2024
• Primary Completion: April 1, 2024
• Study Completion: May 1, 2024
• Last Updated: May 20, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)