NCT07429136Recruiting
Plant-based Protein-rich Weight Loss Intervention in 55+ Adults With Obesity
Source: ClinicalTrials.gov · Last updated 24 Feb 2026
Brief summary (registry, in English)
The objective of the 2EAT RCT is to investigate whether a shift towards more plant-based (≥60% with a minimum of 50%) protein intake can be achieved in an energy restricted diet for three and six months in older adults (55+) with obesity. The 2EAT researchers developed a new dietary counseling plan for six months. This includes four individual consultations, five group meetings and three 24h-recalls. In these six months, participants receive dietary counseling focused on energy restriction (-500 kcal), higher protein intake (aim towards 1.2 g/kg/d, minimum of 0.8 g/kg/d). Participants are randomly allocated either to the more plant-based diet (≥60%) or the more animal-based diet (≥60%). At the start of the intervention, participants are provided with a workbook and recipe book. Secondary objectives are to assess the effect after three and six months 2EAT dietary treatment on 1) weight loss and 2) skeletal muscle mass. Exploratory objectives are to assess the effect after three and six months 2EAT dietary treatment on 1) physical health outcomes (muscle mass and physical performance), 2) body composition, 3) metabolic blood parameters, 4) vitality and quality of life, 5) nutritional intake, 6) behavioral changes, 7) evaluate the process of the dietary treatment.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 200 (estimated)
- First submitted
- 8 Dec 2025
- Start date
- 13 Aug 2024
- Primary completion date
- 1 Oct 2026
- Lead sponsor
- Amsterdam University of Applied Sciences
- Diseases
- Obesity
- NCT number
- NCT07429136
What you commit to
- Study type: Interventional
- Planned participants: 200
- From 13 Aug 2024 to the primary completion date, 1 Oct 2026
- 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
- Alcohol or drug abuse in the opinion of the investigator
- Bariatric surgery
- Active medical treatment interfering with this intervention (e.g. weight loss medication as Ozempic, cancer patients receiving systemic and immune therapy)
Other illness
- Cognitive impairment (MMSE \<15)
- Diagnosed with unstable coronary heart disease (CHD), decompensated heart failure, uncontrolled hypertension or uncontrolled arrhythmias (e.g. heart failure NYHA \>3)
- Diagnosed degenerative neurocognitive disorders
- Diagnosed with renal failure
Lab values
- Planned a holiday during the intervention period and is unable to attend group- or individual sessions for \> 3 weeks
- The health conditions below will be assessed by the study physician. When a condition interferes the dietary treatment or if the diet worsens the participants health it counts as exclusion criteria:
Other
- Inability to understand the Dutch language
- Use of total or partial parenteral nutrition (TPN)
- Current enrolment in a fixed rehabilitation program or other intervention studies
- Palliative treatment or a life expectancy of ≤ 3 months
- Following a vegetarian or vegan (100% plant-based) diet
- Physical disabled: unable to meet the general daily exercise guideline for adults
- COPD GOLD \>3
Who the study is looking for
- Aged 55 or older
- Are obese: have a BMI of \>30 kg/m2 or BMI \>27 kg/m2 and waist circumference \>88 cm (women) or \>102 cm (men)
- Living independently (not in a health facility)
- The willingness that the general practitioner will be notified of study participation
- Written informed consent
- Willingness to comply with the protocol
- Consent of the study physician
Age in the registry: 55 years to - · Sex: All · Does not accept 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 |
|---|---|---|---|
| Hogeschool van Amsterdam Coordinator of this site? Confirm its status | Amsterdam | Netherlands | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.