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

Обзор

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.

Вмешательства

• Поведенческое 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%).

Первичные конечные точки

• Feasibility of high plant-based protein intake while simultaneously striving for weight loss and increased protein intake [Срок оценки: At baseline (week 0), in week 13 (halfway), in week 26 (end), and optional follow-up (week 52)]

Вторичные конечные точки (4)

• Feasibility of a weight loss diet during a more plant-based, higher protein intake [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: At baseline (week 0), in week 13 (halfway), in week 26 (end), and optional follow-up (week 52)]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Нидерланды · 1 центр

• Hogeschool van Amsterdam — Amsterdam

Идентификаторы

NCT: NCT07429136 · RAAK.PRO04.033 - RCT

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗