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

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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. 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
Participation Requirements
Sex: All
Minimum Age: 55
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Netherlands
Hogeschool van Amsterdam
RECRUITING
Amsterdam
Contact Information
Primary
Susanne Wildemast
s.wildemast@hva.nl
+31623492734
Backup
Sjors Verlaan
s.verlaan@hva.nl
+31657442955
Time Frame
Start Date: 2024-08-13
Estimated Completion Date: 2027-04-01
Participants
Target number of participants: 200
Treatments
Experimental: More plant-based diet
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).
Experimental: More animal-based diet
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).
Related Therapeutic Areas
Sponsors
Leads: Amsterdam University of Applied Sciences

This content was sourced from clinicaltrials.gov