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Feasibility of a food-based very-low-energy diet (VLED) in adults with obesity

A single-arm feasibility study of a food-based very-low energy diet (VLED) in adults with obesity

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12625001026415
Enrollment
10
Registered
2025-09-17
Start date
2025-10-08
Completion date
2025-11-14
Last updated
2026-01-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This study aims to evaluate the feasibility and acceptability of delivering a food-based very-low-energy diet (VLED) as a strategy to support weight loss in adults with obesity. VLEDs provide fewer than 800 calories per day and are widely used to achieve rapid weight loss, such as before surgery or to manage weight-related health conditions. Traditionally, VLEDs rely on specially formulated meal replacement products (e.g., shakes, soups, bars). While effective, these products can present challenges for some individuals, including taste fatigue, limited variety, and difficulty maintaining adherence in social settings. This study will investigate whether an alternative approach - using everyday, conventional foods to deliver a nutritionally balanced VLED over 8 weeks - can be practical and acceptable. By using real foods, this intervention may improve adherence and satisfaction, while still achieving clinically meaningful weight loss in the long term. Importantly, this approach could broaden the use of VLEDs beyond formula-based products, offering a flexible option that can be integrated with other weight loss strategies, such as medications or bariatric surgery, while maximising nutritional adequacy under low energy intakes.

Interventions

This single-centre, open-label study that explores the feasibility of a food-based very-low-energy diet (VLED) for adults with obesity. Participants will follow a balanced and nutritionally adequate, food-based VLED (<800 kcal/day) for 8 weeks. Participants will procure and prepare their own food during the intervention. Participants will be provided with written resources such as meal plan templates and food lists, which have been designed specifically for this study. To ensure participant un

This single-centre, open-label study that explores the feasibility of a food-based very-low-energy diet (VLED) for adults with obesity. Participants will follow a balanced and nutritionally adequate, food-based VLED (<800 kcal/day) for 8 weeks. Participants will procure and prepare their own food during the intervention. Participants will be provided with written resources such as meal plan templates and food lists, which have been designed specifically for this study. To ensure participant understands the dietary instructions and capable of making appropriate and realistic food choices, a sample meal plan will be co-created with the participant during the initial visit. Participants with specific dietary preferences, allergies and intolerances will be supported to identify suitable alternatives to meet individual needs, if specific needs extend the scope of the available resources. Fortnightly dietitian-led visits will monitor feasibility outcomes including self-reported acceptability of the diet, dietary adherence, weight, waist and hip circumferences, body composition, blood pressure, and adverse effects. Individualised dietary advice, which account for individual dietary preferences and food allergies/intolerances, will be also provided by the study dietitian as needed at these visits. Blood and urine samples will be taken at baseline and week 8. During the final visit in week 8, participants will be asked to participate in an audio-recorded semi-structured interview regarding their perceptions and experiences of the intervention. Duration of initial (baseline) visit is 1 hour. Follow up visits (week 2, 4, 6) 30 minutes. Final (week 8) visit including semi-structured interview 1.5 hours, of which the interview is 30 minutes.

Sponsors

University of Melbourne
Lead SponsorUniversity

Study design

Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

Adults aged between 18 – 65 years and BMI greater than or equal to 30 kg/metres squared or BMI greater than 27 kg/metres squared with 1 weight-related medical condition

Exclusion criteria

Contraindications to VLED, including: 1. Lactating, pregnant or of childbearing potential who are not willing to avoid becoming pregnant during the intervention 2. Myocardial infarction, cerebrovascular event or unstable angina within last 3 months 3. Porphyria 4. Unstable psychiatric conditions

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026