Acute Intervention to Assess the Impact of Practical Strategies to Facilitate a Balanced and Healthy Diet
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Change from baseline (standard tookit condition) in consumed portion size of carbohydrate under the portion-control toolkit condition
研究概览
简要总结
Obesity has reached epidemic proportions globally, alongside its associated comorbidities including cardiovascular diseases, diabetes and cancer. Effective weight management strategies are thus paramount to improve the population´s health. One of the key causes of obesity lies in excessive energy consumption derived from eating too large portions of food. In this context, practical tools to control portion size represent a promising, cost-effective strategy.
This study will investigate whether using an optimized portion-control toolkit to consume a meal under controlled laboratory conditions has a positive effect on the nutritional quality of the meal as well as any benefits in physiological, cognitive, affective and behavioural outcomes.
The study will involve 40 volunteers with overweight or obesity who will attend two lunch sessions at the Center for Nutrition Research of the University of Navarra (Spain) on two different days. At each session, participants will be invited to self-serve and eat a lunch from a cold buffet. On day one, participants will self-serve and season their food using control tools (conventional kitchen serving spoons and oil dispenser). On day two, participants will self-serve the same foods as on day one but using experimental tools (calibrated portion-control serving spoons and calibrated oil dispenser). A set of cognitive tests will be completed before, during and after the meal.
Conventional and experimental tools will be compared in terms of the following variables: meal portion size and energy density, cognitive effort while serving food, cephalic and intestinal satiety responses, appetite sensations, energy adjustment post-meal, awareness of the quantities of the previously consumed foods and recalibration of portion size norms. Additionally, the study will explore acceptance for and intention to use the optimized portion control toolkit, as well as intention to change eating habits.
It is expected that the findings from this study will shed light into the cognitive and physiological processes associated with portion control. It may also help to explain individual variations in the responses to obesogenic environments, which will hopefully lead to improved personalized interventions.
详细描述
Study justification:
The prevalence of obesity and associated health-risks (e.g. cardiovascular disease, diabetes and cancer) continues to increase across the globe, raising the need for effective weight management strategies to improve the population´s health. High rates of obesity respond at least in part, to the current obesogenic environment that prompts people to overeat both in terms of energy and amount. In this context, access to practical tools that can help individuals control their portion sizes represent a promising, cost-effective strategy. However, urging people to "eat less" of all foods might be challenging as individuals are used to consume a certain volume of food to feel satisfied. Instead, a more effective approach may be to help people lower the energy density of their meals through the increase in the amount of fruits and vegetables in their diet at the expense of high energy density foods, such as foods rich in fat and starch. Portion-control plates and serving utensils, designed to measure the appropriate amounts and proportions of main food groups (e.g. starch, protein and vegetables), can actually facilitate this shift. Our recent systematic review (https://pubmed.ncbi.nlm.nih.gov/34207492/) found that portion-control plates in particular were the most promising tools to regulate intake and develop healthier eating habits. However, some of the studies conducted up to date have explored the effect of different portion control tools in combination with other weight management strategies, making it difficult to determine the impact of these instruments on their own. The design of the tools may also negatively affect success if instruments don´t fit the user´s lifestyle and eating routines. Individual characteristics such as sex and BMI have also been found to modulate the success of portion control tools. Therefore, optimizing the current tools is needed to achieve a wider impact.
Specific aims:
The primary goal of the present study is to investigate the acute effects of using a portion control tableware toolkit, optimized based on our previous quantitative and qualitative work with portion control tableware, in people with overweight and obesity. The intervention will be conducted under controlled laboratory conditions in order to obtain proof of concept of the toolkit efficacy before application into field studies. The secondary goal is to gain knowledge on the cognitive and physiological mechanisms involved in portion size regulation mediated by portion control tools.
It is expected that the findings from this study will shed light into the cognitive and physiological processes associated with portion control. It may also help to explain individual variations in the responses to obesogenic environments, which will hopefully lead to improved personalized interventions. The ultimate goal is to develop effective, easy, attractive and affordable strategies that could help individuals prevent overeating.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Single (Participant)
盲法说明
The study will be advertised as research on practical strategies to facilitate a balanced and healthy diet.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults aged between 18 and 65 years
- •BMI between 27.5 and 39 kg/m-sq, except for Asian participants (BMI 26 to 39 kg/m-sq)
- •Good gastrointestinal health
- •Good visual acuity or wearing contact lenses
- •Regular eating habits (i.e. consuming lunch and dinner at least 5 days a week)
- •Liking of at least one of the foods from the three major categories (vegetables, protein, and starch)
- •Willingness to provide blood samples
- •Availability to attend two clinical visits at lunch time
排除标准
- •Malnutrition (including dehydration; anaemia; blood donation within less than 3 months)
- •Gastrointestinal disorders
- •Eating disorders (a score of 20 or more in the EAT-26)
- •Elevated stress levels (a score of 27 or more in the PSS-14)
- •Need to wear glasses to self-serve food
- •Being on a diet to gain or lose weight (leading to >7.5% body weight change in the last 3 months)
- •Food allergies or restrictions impacting food choices at the buffet meal (including veganism)
- •Active medical conditions like diabetes, cancer, epilepsy, memory loss impacting on food behaviour and/or body weight
- •Taking medications affecting appetite, body weight, memory or sight, except if the person has been on a stable dose for the past 3 months and no symptoms have been experienced
- •Using a pacemaker/other electronic medical device that may interfere with the eye tracking equipment or software
- •Smokers, drinkers, athletes and pregnant or lactating women
- •Knowledge that can affect the results of the study (e.g., nutritionists/dietitians, those with previous training in eating behaviour research)
- •Participation in the preceeding qualitative study.
- •Menstrual cycle in women will not be controlled for but day of last menstruation in pre-menopausal women will be recorded. Post-menopausal women will not be excluded; however, this detail will be noted at screening, with an individual's menopausal status (pre, peri or post).
- •Candidates working shifts may be eligible if they are able to attend a clinical visit at least 12 hours since the last shift, to ensure they have sufficient sleep and their appetite sensations are not altered.
结局指标
主要结局
Change from baseline (standard tookit condition) in consumed portion size of carbohydrate under the portion-control toolkit condition
时间窗: Clinical Investigation Day 1, Clinical Investigation Day 2
Grams of consumed carbohydrate
次要结局
- Change from baseline (standard tookit condition) in post-prandial blood pancreatic polypeptide at 7 min under the portion-control toolkit condition(Clinical Investigation Day 1, Clinical Investigation Day 2)
- Change from baseline (standard tookit condition) in post-prandial blood pancreatic polypeptide at 62 min under the portion-control toolkit condition(Clinical Investigation Day 1, Clinical Investigation Day 2)
- Change from baseline (standard tookit condition) in post-prandial blood ghrelin at 12 min under the portion-control toolkit condition(Clinical Investigation Day 1, Clinical Investigation Day 2)
- Change from baseline (standard tookit condition) in post-prandial blood glucose at 62 min under the portion-control toolkit condition(Clinical Investigation Day 1, Clinical Investigation Day 2)
- Change from baseline (standard tookit condition) in consumed portion size of protein under the portion-control toolkit condition(Clinical Investigation Day 1, Clinical Investigation Day 2)
- Change from baseline (standard tookit condition) in post-prandial blood pancreatic polypeptide at 12 min under the portion-control toolkit condition(Clinical Investigation Day 1, Clinical Investigation Day 2)
- Change from baseline (standard tookit condition) in post-prandial blood ghrelin at 7 min under the portion-control toolkit condition(Clinical Investigation Day 1, Clinical Investigation Day 2)
- Change from baseline (standard tookit condition) in served portion size of vegetables under the portion-control toolkit condition(Clinical Investigation Day 1, Clinical Investigation Day 2)
- Change from baseline (standard tookit condition) in post-prandial blood insulin at 12 min under the portion-control toolkit condition(Clinical Investigation Day 1, Clinical Investigation Day 2)
- Change from baseline (standard tookit condition) in consumed portion size of vegetables under the portion-control toolkit condition(Clinical Investigation Day 1, Clinical Investigation Day 2)
- Change from baseline (standard tookit condition) in consumed portion size of fat under the portion-control toolkit condition(Clinical Investigation Day 1, Clinical Investigation Day 2)
- Change from baseline (standard tookit condition) in served portion size of fibre under the portion-control toolkit condition(Clinical Investigation Day 1, Clinical Investigation Day 2)
- Change from baseline (standard tookit condition) in post-prandial blood glucose at 7 min under the portion-control toolkit condition(Clinical Investigation Day 1, Clinical Investigation Day 2)
- Change from baseline (standard tookit condition) in post-prandial blood glucose at 12 min under the portion-control toolkit condition(Clinical Investigation Day 1, Clinical Investigation Day 2)
- Change from baseline (standard tookit condition) in post-prandial blood pancreatic polypeptide at 32 min under the portion-control toolkit condition(Clinical Investigation Day 1, Clinical Investigation Day 2)
- Change from baseline (standard tookit condition) in post-prandial blood pancreatic polypeptide at 92 min under the portion-control toolkit condition(Clinical Investigation Day 1, Clinical Investigation Day 2)
- Change from baseline (standard tookit condition) in post-prandial blood ghrelin at 32 min under the portion-control toolkit condition(Clinical Investigation Day 1, Clinical Investigation Day 2)
- Change from baseline (standard tookit condition) in post-prandial blood ghrelin at 92 min under the portion-control toolkit condition(Clinical Investigation Day 1, Clinical Investigation Day 2)
- Pupil dilation (mm)(Clinical Investigation Day 2)
- Change from baseline (standard tookit condition) in consumed portion size of fibre under the portion-control toolkit condition(Clinical Investigation Day 1, Clinical Investigation Day 2)
- Change from baseline (standard tookit condition) in served portion size of carbohydrate under the portion-control toolkit condition(Clinical Investigation Day 1, Clinical Investigation Day 2)
- Change from baseline (standard tookit condition) in served portion size of protein under the portion-control toolkit condition(Clinical Investigation Day 1, Clinical Investigation Day 2)
- Change from baseline (standard tookit condition) in served portion size of fat under the portion-control toolkit condition(Clinical Investigation Day 1, Clinical Investigation Day 2)
- Change from baseline (standard tookit condition) in post-prandial blood glucose at 32 min under the portion-control toolkit condition(Clinical Investigation Day 1, Clinical Investigation Day 2)
- Change from baseline (standard tookit condition) in post-prandial blood glucose at 92 min under the portion-control toolkit condition(Clinical Investigation Day 1, Clinical Investigation Day 2)
- Change from baseline (standard tookit condition) in post-prandial blood insulin at 7 min under the portion-control toolkit condition(Clinical Investigation Day 1, Clinical Investigation Day 2)
- Change from baseline (standard tookit condition) in post-prandial blood insulin at 32 min under the portion-control toolkit condition(Clinical Investigation Day 1, Clinical Investigation Day 2)
- Change from baseline (standard tookit condition) in post-prandial blood insulin at 62 min under the portion-control toolkit condition(Clinical Investigation Day 1, Clinical Investigation Day 2)
- Change from baseline (standard tookit condition) in post-prandial blood insulin at 92 min under the portion-control toolkit condition(Clinical Investigation Day 1, Clinical Investigation Day 2)
- Change from baseline (standard tookit condition) in post-prandial blood ghrelin at 62 min under the portion-control toolkit condition(Clinical Investigation Day 1, Clinical Investigation Day 2)
- Total serving time (min)(Clinical Investigation Day 2)
- Visual fixation time (sec)(Clinical Investigation Day 2)