Obesity2EATNCT07429136
Plant-based Protein-rich Weight Loss Intervention in 55+ Adults With Obesity
A study testing More plant-based protein intake during weight loss in people with Obesity, run by Amsterdam University of Applied Sciences at 1 site in Netherlands.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Obesity
- What is being tested?
- More plant-based protein intake during weight loss
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteNetherlands
- Study dates
- 13 Aug 2024to 1 Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Inability to understand the Dutch language
- Cognitive impairment (MMSE <15)
- Use of total or partial parenteral nutrition (TPN)
- Alcohol or drug abuse in the opinion of the investigator
- Current enrolment in a fixed rehabilitation program or other intervention studies
- Palliative treatment or a life expectancy of ≤ 3 months
Show all 16Show fewer
- Following a vegetarian or vegan (100% plant-based) diet
- Bariatric surgery
- Active medical treatment interfering with this intervention (e.g. weight loss medication as Ozempic, cancer patients receiving systemic and immune therapy)
- Physical disabled: unable to meet the general daily exercise guideline for adults
- 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:
- 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
- COPD GOLD >3
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands1 site, 1 recruiting
- Recruiting
Hogeschool van Amsterdam
Amsterdam, South Holland, 1067SM
Wildemast, 0641679606, s.wildemast@hva.nl
About this study
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.
- Conditions
- Obesity
- Being tested
- More plant-based protein intake during weight loss
- Keywords
- Obesity, Ageing
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
More plant-based protein intake during weight lossBehavioural
Participants receive dietary counseling for six months focusing on 1) energy restriction (-500 kcal), 2) higher protein intake (aim 1.2 g/kg/d, minimum 0.8 g/kg/d) and according to their assigned diet, either 3) more plant-based protein (≥60%) or more animal-based protein (≥60%).
| Study group | Role | What they receive |
|---|---|---|
| More plant-based diet | Experimental | Participants receive dietary counseling for six months focusing on 1) more plant-based protein (≥60%), 2) higher protein intake (aim 1.2 g/kg/d, minimum 0.8 g/kg/d) and 3) energy restriction (-500 kcal). Receives: Behavioral: More plant-based protein intake during weight loss |
| More animal-based diet | Experimental | Participants receive dietary counseling for six months focusing on 1) more animal-based protein (≥60%), 2) higher protein intake (aim 1.2 g/kg/d, minimum 0.8 g/kg/d) and 3) energy restriction (-500 kcal). Receives: Behavioral: More plant-based protein intake during weight loss |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of high plant-based protein intake while simultaneously striving for weight loss and increased protein intake
Three-day food record (plant protein intake as part of total protein intake; g/day)
Measured: At baseline (week 0), in week 13 (halfway), in week 26 (end), and optional follow-up (week 52)
Secondary outcomes (4)
Feasibility of a weight loss diet during a more plant-based, higher protein intake
Three-day food record on energy (kcal/day)
Measured: At baseline (week 0), in week 13 (halfway), in week 26 (end), and optional follow-up (week 52)
Feasibility of an increased protein intake during a more plant-based protein, weight loss diet
Three-day food record on protein intake (g/day)
Measured: At baseline (week 0), in week 13 (halfway), in week 26 (end), and optional follow-up (week 52)
Effect of 2EAT dietary treatment on weight loss
Body weight in kg (calibrated weighing scales)
Measured: At baseline (week 0), in week 13 (halfway), in week 26 (end), and optional follow-up (week 52)
Effect of 2EAT dietary treatment on skeletal muscle mass
Skeletal muscle mass (appendicular lean soft tissue (ALST) in kg) via a DXA-scan
Measured: At baseline (week 0), in week 13 (halfway), in week 26 (end), and optional follow-up (week 52)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2026
- Study start13 Aug 2024
- Primary completion1 Oct 2026 (estimated)
- Study completion1 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are either assigned to the 1) more plant-based diet group, or the 2) more animal-based diet group.
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Amsterdam University of Applied Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Peter Weijs, Principal investigator, Amsterdam University of Applied Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07429136
- Sponsor's protocol ID
- RAAK.PRO04.033 - RCT
- Acronym
- 2EAT
- Status last verified
- Dec 2025
- First submitted
- 8 Dec 2025
- Last updated
- 24 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Participants have agreed or disagreed to share data later. At this moment it is still undecided whether we will share data.
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Plant-based Protein-rich Weight Loss Intervention in 55+ Adults With Obesity
- ClinicalTrials.gov ID
- NCT07429136
- Acronym / sponsor ID
- 2EAT / RAAK.PRO04.033 - RCT
- Conditions
- Obesity
- Keywords
- Obesity, Ageing
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Amsterdam University of Applied SciencesUniversity, hospital or other
- Study start
- 13 Aug 2024 (actual)
- Primary completion
- 1 Oct 2026 (estimated)
- Study completion
- 1 Apr 2027 (estimated)
- First posted
- 24 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants are either assigned to the 1) more plant-based diet group, or the 2) more animal-based diet group.
| Arm | Type | Receives |
|---|---|---|
| More plant-based diet | Experimental | Behavioral: More plant-based protein intake during weight lossParticipants receive dietary counseling for six months focusing on 1) more plant-based protein (≥60%), 2) higher protein intake (aim 1.2 g/kg/d, minimum 0.8 g/kg/d) and 3) energy restriction (-500 kcal). |
| More animal-based diet | Experimental | Behavioral: More plant-based protein intake during weight lossParticipants receive dietary counseling for six months focusing on 1) more animal-based protein (≥60%), 2) higher protein intake (aim 1.2 g/kg/d, minimum 0.8 g/kg/d) and 3) energy restriction (-500 kcal). |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (16 listed)
- Inability to understand the Dutch language
- Cognitive impairment (MMSE <15)
- Use of total or partial parenteral nutrition (TPN)
- Alcohol or drug abuse in the opinion of the investigator
- Current enrolment in a fixed rehabilitation program or other intervention studies
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| More plant-based protein intake during weight lossParticipants receive dietary counseling for six months focusing on 1) energy restriction (-500 kcal), 2) higher protein intake (aim 1.2 g/kg/d, minimum 0.8 g/kg/d) and according to their assigned diet, either 3) more plant-based protein (≥60%) or more animal-based protein (≥60%). | Behavioural | More animal-based diet, More plant-based diet |
Primary outcome
Feasibility of high plant-based protein intake while simultaneously striving for weight loss and increased protein intake
Time frame: At baseline (week 0), in week 13 (halfway), in week 26 (end), and optional follow-up (week 52)
Three-day food record (plant protein intake as part of total protein intake; g/day)
4 secondary outcomes
Feasibility of a weight loss diet during a more plant-based, higher protein intake
Time frame: At baseline (week 0), in week 13 (halfway), in week 26 (end), and optional follow-up (week 52)
Feasibility of an increased protein intake during a more plant-based protein, weight loss diet
Time frame: At baseline (week 0), in week 13 (halfway), in week 26 (end), and optional follow-up (week 52)
Effect of 2EAT dietary treatment on weight loss
Time frame: At baseline (week 0), in week 13 (halfway), in week 26 (end), and optional follow-up (week 52)
Effect of 2EAT dietary treatment on skeletal muscle mass
Time frame: At baseline (week 0), in week 13 (halfway), in week 26 (end), and optional follow-up (week 52)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2026.
- Individual participant dataSharing planned: Undecided. Participants have agreed or disagreed to share data later. At this moment it is still undecided whether we will share data.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Peter Weijs principal investigator
Amsterdam University of Applied Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing More plant-based protein intake during weight loss in people with Obesity, run by Amsterdam University of Applied Sciences at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Susanne Wildemast (+31623492734, s.wildemast@hva.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of high plant-based protein intake while simultaneously striving for weight loss and increased protein intake (time frame: At baseline (week 0), in week 13 (halfway), in week 26 (end), and optional follow-up (week 52)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2026.