Intermittent Fasting Compared to Continuous Energy Restriction on Body Weight Loss

Summary

Obesity remains a major public health challenge. Intermittent fasting continues to gain popularity compared to continuous energy restriction as a weight-loss approach for cardiometabolic health. Studies to date comparing intermittent energy restriction (IER) and continuous energy restriction (CER) have not been investigated on weight loss and cardiometabolic risk markers in low-income countries like Nepal. The main objective of this study is to compare the effectiveness of IER versus CER diet on weight loss and cardiometabolic risk markers over the course of six months among overweight/obese Nepalese population.

This study will adopt a parallel arm, open-label, randomized control trial design. The study duration will be six months from baseline to endline. A total of 112 overweight and obese participants, aged 18-64 years, with waist circumference \>90 cm (men) and \>80 cm (women) will be enrolled in the study. Interested participants will be approached through social media and consecutively enrolled and assigned to either IER group (n=56) or CER group (n=56) randomly. Participants will be provided Mediterranean pattern dietary intervention including two groups: IER group will receive 5:2 diet pattern (5 day without energy restriction and 2 days with 75% energy restriction, net weekly energy deficit \~25%), and CER group with a low-calorie diet (daily energy deficit \~25%) over the course of six months. Both IER and CER group will be provided personalized diet plan, portion size, nutrition counseling focus on dietary guidance, motivational strategies, and personal goal setting for behavior change with educational materials. Baseline data will be collected using a structured questionnaire and the biochemical tests will be done. Baseline data will be collected at the time of enrollment, midline in three months, and end-line data collection in six months. The primary outcome of this study will be the change in weight loss between IER and CER groups. The secondary outcome measure will be to evaluate changes in nutritional composition, eating behavior, and cardiometabolic risk markers between IER and CER group over six months. Data will be entered using Epidata Software and transferred to the Stata/MP version 14.1 for further analysis. Data will be analyzed using an intention-to-treat basis. Independent t-test and, repeated measures ANOVA will be used to estimate changes between-group comparisons. The significance level will be assumed at p\<0.05

Conditions

• Overweight and Obesity

Interventions

BEHAVIORAL

Intermittent energy restriction (IER) : 5:2 diet pattern

Participants in the IER group will be provided menus on fasting day that provide \~25% of the individual energy requirement (400 kcal/day for females and 600 kcal/day for males) that means \~75% energy restriction per week (Sundfør et al., 2018; Svendsen, 2018; Templeman, Gonzalez, Thompson, \& Betts, 2020). The recommended fasting day may be on two non-consecutive days (Mondays and Thursdays) per week and remaining five days of the week will be based on the usual diet plan. All participants will be instructed to complete all food by 12 pm and then fast until 8 am the following day (Svendsen, 2018).Thus, the weekly average calorie intake will correspond to \~75% of the normal energy requirements. They will receive a diet plan that recommended \~50 gm protein/day from chicken breast, lean meat, lean fish, fat-free yogurt, cottage cheese, egg or legumes, and vegetables to increase satiety on fasting days.

BEHAVIORAL

Continuous energy restricted (CER) group

Participants in the CER group will be advised to reduce total energy intake to 1200-1550 kcal in all seven days a week. They will be provided diet plan calculated in relation to each person's estimated energy requirements. Menus will be divided into breakfast, lunch, dinner, and snacks in line with their individualized energy recommendations. They will be requested to consume \~75% of the individual energy requirements daily (25% energy restriction of calculated baseline energy requirements daily) over six months. Thus, the overall energy restriction will similar between the groups at an estimated reduction of 25% of requirements. Participants will be randomized in a 1:1 ratio, and assigned to an intermittent or continuous energy restriction group randomly.

Sponsors & Collaborators

• Armed Police Force Hospital, Nepal

  lead OTHER_GOV

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

64 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2023-04-01

Primary Completion

2023-09-01

Completion

2023-10-01

Countries

• Nepal

Study Locations