Our primary objective of the feasibility study is to assess the acceptability and feasibility of the developed 2EAT dietary treatment in older adults with obesity. The primary objective the main study (RCT) is to investigate whether a shift towards…
ID
Source
Brief title
Condition
- Other condition
- Appetite and general nutritional disorders
Synonym
Health condition
Sarcopene obesitas
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameter is the change in plant-based protein intake compared
to animal protein intake between baseline and three (primary) and six-months
intervention (3-day dietary record).
Secondary outcome
Weight loss;
Skeletal muscle mass;
Exploratory parameters:
Muscle strenth: hand grip strength
Physical performance: 400m walk test, short physical performance battery
Body composition: fat free mass, total body water, body weight, waist
circumference, BMI
Metabolic outcomes: blood pressure, heart rate, lipid profile, blood glucose
(HOMA-index), inflammation (CRP), nutritional status (vitamin B12 and
heamoglobin)
Quality of live
Vitality
Nutritional adequacy
Behavioral change
Process evaluation of the dietary treatment
Background summary
In the Netherlands, there is a high prevalence of obesity among older adults
(55+) which is expected to rise in the coming years. Weight loss is crucial to
improving health outcomes for older adults, but it also poses the risk of
losing skeletal muscle mass. Therefore, dietetic advice for older obese clients
should consider the exacerbated age-related loss of skeletal muscle mass and
encourage the intake of extra proteins, alongside calorie restriction.
Currently, dieticians typically suggest an increase in animal-based proteins
due to their proven ability to stimulate muscle protein synthesis. On average
60% of the protein intake in the Netherlands is of animal-based sources.
However, animal-based proteins have a high ecological impact, while plant-based
proteins have a lower impact and offer numerous health benefits. To address
this, we developed a new dietary concept that aligns with current dietary
guidelines for older adults (55+) with obesity, incorporating a calorie
restriction and protein enrichment (towards 1.2 g/kg/d, minimum of 0.8 g/kg/d),
of which >=60% (minimum of 50%) (compared to current 40%) is plant-based
proteins and providing all essential amino acids.
Study objective
Our primary objective of the feasibility study is to assess the acceptability
and feasibility of the developed 2EAT dietary treatment in older adults with
obesity.
The primary objective the main study (RCT) is to investigate whether a shift
towards more plant-based (>=60%) protein intake can be achieved in a calorie
restricted diet for three (primary) and six months in older adults (55+) with
obesity.
The secondary objectives of the study are to assess the effects of the 2EAT
dietary treatment on weight loss and skeletal muscle mass.
The exploratory objectives of the study are to assess the effect of the 2EAT
dietary treatment on physical health outcomes: muscle strength and physical
performance; body composition; metabolic bloodparameters; vitality and quality
of life; nutritional intake; behavioral changes; process of dietary treatment.
Study design
The study consists of two phases. In phase 1, a feasibility study will evaluate
the acceptability and feasibility of the 2EAT dietary treatment in older adults
with obesity. In phase 2, a randomized controlled trial of 6 months with two
parallel intervention groups will be conducted to investigate the effect of the
2EAT diet (>=60% plant-based protein) over time.
Intervention
The 2EAT dietary intervention includes dietary counselling focussed on
behavioural change, and a diet with an energy restriction of 500 kcal and
increased protein intake based towards 1.2 g/kg/day (minimum of 0.8 g/kg/d), of
which >=60% (minimum of 50%) is plant-based. In the randomized controlled trial,
half of the participants will be randomized to the control dietary treatment
(40% plant-based protein).
Study burden and risks
The risks associated with participation are minimal. Assessments will be
carried out in a private controlled setting and interventions are guided by
trained dieticians and researchers. Participation in this study should benefit
older adults by improving body composition, providing social aspects and
personal health insights. The results of this trial will be used to support
evidence-based practice for more environmentally sustainable dietetic practice.
De boelelaan 1117
Amsterdam 1081 HV
NL
De boelelaan 1117
Amsterdam 1081 HV
NL
Listed location countries
Age
Inclusion criteria
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
Exclusion criteria
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 such as Ozempic cancer patients receiving systemic and immune
therapy)
Physical disabled: unable to meet the general daily exercise guideline for
adults (24)
Planned a holiday during the intervention period and is unable to attend group-
or individual sessions for > 1 week (in phase 1) or > 3 weeks (in phase 2)
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
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
CCMO | NL84358.018.23 |