NCT05627570Completed
A Study Comparing the Health Effects of Two Diets Following UK Dietary Guidance in People Living With Overweight or Obesity
Investigating the Effects of Diets With Different Types of Food Processing Following UK dietAry Guidance on healTh outcomEs: an 8-week Community-based Crossover Randomised Controlled Trial in People With Overweight or Obesity, Followed by a 6-month Behavioural Intervention
Source: ClinicalTrials.gov · Last updated 24 Jun 2025
Brief summary (registry, in English)
There are two parts to this study: 1. The investigators will study if the benefit from eating a healthy, balanced diet depends on the types of food processing in the diet. The investigators will do this by providing participants with two diets that follow the Eatwell Guide (referred to in this study as Diet A and Diet B to avoid unblinding), but containing foods with different types of food processing, for 8 weeks each. The investigators will collect data on blood pressure, body composition, physical activity and fitness, questions regarding quality of life, mental health and wellbeing, and blood samples at the start of each diet and at 4 and 8 weeks into each diet. 2. The investigators will then study whether participants are able to switch from their usual unhealthy diet to a healthy, balanced diet, and the benefits of doing so. The investigators will do this by providing participants with 6 months of personal support. The investigators will also look at what helps participants to maintain a healthy diet, and what makes it difficult. The investigators will also support participants to be more physically active.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 55 (actual)
- First submitted
- 11 Nov 2022
- Start date
- 1 Mar 2023
- Primary completion date
- 14 Oct 2024
- Lead sponsor
- University College, London
- Diseases
- Obesity
- NCT number
- NCT05627570
What you commit to
- Study type: Interventional
- Participants enrolled: 55
- From 1 Mar 2023 to the primary completion date, 14 Oct 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Concomitant usage of medications that cause weight gain or weight loss
Other illness
- Cardiometabolic comorbidities (e.g. diabetes, on insulin)
- Coeliac disease
- Inflammatory bowel disease
- A diagnosed eating disorder
- Any diagnosed food allergy, or other allergies which limit the ability to adhere to the intervention diet
- A history of drug or alcohol abuse
Other
- Contraindication for dietary intervention
- Participation in another clinical intervention trial
- Planning a weight management programme in the next 3 months
- Dietary restrictions (e.g. vegan or vegetarian) which limit the ability to adhere to the interventions
- BMI \>40 kg/m2 or basal metabolic rate ≥2300/kcal/day (to ensure intervention diets are at least 300kcal/day greater than maintenance energy needs).
- Females who are pregnant, breast-feeding, or intends to become pregnant.
- Any other factor making the participant unsuitable in the view of investigator.
Who the study is looking for
- Staff at University College London Hospitals (UCLH)
- Adults aged between \[18 and 65\] years old.
- BMI ≥25 kg/m2 (living with overweight or obesity)
- Weight stable for the past 3 months (≤5 % variation in body weight over preceding 3 months)
- Have a habitual dietary intake high in unhealthy food
- Able to read and write in English.
- Medically safe to participate in a dietary intervention programme.
- Willing and able to give written informed consent.
- Able to attend the relevant in person and online sessions.
- Able to comply with the study protocol (including dietary recommendations for each intervention and reporting adherence).
- Females of childbearing potential and males agree to use an effective method of contraception from the time consent is signed until the end of the intervention period and final follow-up assessment. Effective methods of contraception acceptable for this trial are outlined in Appendix 2.
- Females of childbearing potential must be on highly effective contraception and have a negative pregnancy test within 7 days of being randomised. NOTE: Participants are considered not of childbearing potential if they have undergone a hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or they are postmenopausal.
Age in the registry: 18 years to 65 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| UCL Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.