About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Parallel
Treatments tested in this trial
More plant-based protein intake during weight loss
BehavioralParticipants 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%).
Treatment groups
Trial outcomes
Primary outcomes
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)
Secondary outcomes
Feasibility of a weight loss diet during a more plant-based, higher protein intake
Three-day food record on energy (kcal/day)
Feasibility of an increased protein intake during a more plant-based protein, weight loss diet
Three-day food record on protein intake (g/day)
Effect of 2EAT dietary treatment on weight loss
Body weight in kg (calibrated weighing scales)
Effect of 2EAT dietary treatment on skeletal muscle mass
Skeletal muscle mass (appendicular lean soft tissue (ALST) in kg) via a DXA-scan
Other outcomes
Effect of 2EAT dietary treatment on physical performance
Short Physical Performance Battery (SPPB). Minimum value: 0; Maximum value 12. Score 0-3: severe limitations; score 4-9: intermediate limitations; score 9-12: normal function.
Effect of 2EAT dietary treatment on walking distance
400 meter walk test (MWT) in seconds (s)
Effect of 2EAT dietary treatment on muscle strength
Hand Grip Strength (kg)
Effect of 2EAT dietary treatment on fat free mass
Fat free mass (in kg) via BODPOD air displacement plethysmograph
Locations
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Sponsors and contacts
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