Plant-based Protein-rich Weight Loss Intervention in 55+ Adults With Obesity

Overview

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.

Interventions

• Behavioral More plant-based protein intake during weight loss
  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%).

Primary outcome measures

• 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)]

Secondary outcome measures (4)

• 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)]

Eligibility criteria

Inclusion criteria

• 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

Exclusion criteria

• 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
• 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

Netherlands · 1 center

• Hogeschool van Amsterdam — Amsterdam

Identifiers

NCT: NCT07429136 · RAAK.PRO04.033 - RCT

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗