Plant-based Protein-rich Weight Loss Intervention in 55+ Adults With Obesity
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Feasibility of high plant-based protein intake while simultaneously striving for weight loss and increased protein intake
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 55 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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).
干预措施: More plant-based protein intake during weight loss (Behavioral)
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).
干预措施: More plant-based protein intake during weight loss (Behavioral)
结局指标
主要结局
Feasibility of high plant-based protein intake while simultaneously striving for weight loss and increased protein intake
时间窗: 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)
次要结局
- Feasibility of a weight loss diet during a more plant-based, higher protein intake(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(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(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(At baseline (week 0), in week 13 (halfway), in week 26 (end), and optional follow-up (week 52))