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

ConditionObesity
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age55+
SponsorAmsterdam University of Applied Sciences

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • More plant-based protein intake during weight loss

    Behavioral

    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%).

Treatment groups

200 Participants
are divided into 2 treatment groups
Group A: More plant-based dietExperimental treatment 1 intervention
Group B: More animal-based dietExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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)

Time frame
At baseline (week 0), in week 13 (halfway), in week 26 (end), and optional follow-up (week 52)

Secondary outcomes

1

Feasibility of a weight loss diet during a more plant-based, higher protein intake

Three-day food record on energy (kcal/day)

Time frame
At baseline (week 0), in week 13 (halfway), in week 26 (end), and optional follow-up (week 52)
2

Feasibility of an increased protein intake during a more plant-based protein, weight loss diet

Three-day food record on protein intake (g/day)

Time frame
At baseline (week 0), in week 13 (halfway), in week 26 (end), and optional follow-up (week 52)
3

Effect of 2EAT dietary treatment on weight loss

Body weight in kg (calibrated weighing scales)

Time frame
At baseline (week 0), in week 13 (halfway), in week 26 (end), and optional follow-up (week 52)
4

Effect of 2EAT dietary treatment on skeletal muscle mass

Skeletal muscle mass (appendicular lean soft tissue (ALST) in kg) via a DXA-scan

Time frame
At baseline (week 0), in week 13 (halfway), in week 26 (end), and optional follow-up (week 52)

Other outcomes

1

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.

Time frame
At baseline (week 0), in week 13 (halfway), in week 26 (end), and optional follow-up (week 52)
2

Effect of 2EAT dietary treatment on walking distance

400 meter walk test (MWT) in seconds (s)

Time frame
At baseline (week 0), in week 13 (halfway), in week 26 (end), and optional follow-up (week 52)
3

Effect of 2EAT dietary treatment on muscle strength

Hand Grip Strength (kg)

Time frame
At baseline (week 0), in week 13 (halfway), in week 26 (end), and optional follow-up (week 52)
4

Effect of 2EAT dietary treatment on fat free mass

Fat free mass (in kg) via BODPOD air displacement plethysmograph

Time frame
At baseline (week 0), in week 13 (halfway), in week 26 (end), and optional follow-up (week 52)

Locations

1

Map coordinates are unavailable for these locations. Locations are shown below instead.

Hogeschool van AmsterdamRecruiting1067SM, Amsterdam, South HollandNetherlandsNetherlands

Sponsors and contacts

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