Acute Intervention to Assess the Impact of Practical Strategies for Healthy Eating

NCT05619276 | Completed

• 2 other identifiers: PC171-1722022.121
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Overweight and Obesity; Healthy Diet

Keywords

Portion control tools; Food portion size

Outcome Measures

Primary Outcomes (1)

• Change from baseline (standard tookit condition) in consumed portion size of carbohydrate under the portion-control toolkit condition

  Grams of consumed carbohydrate

  Clinical Investigation Day 1, Clinical Investigation Day 2

Secondary Outcomes (35)

• 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 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 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

Other Outcomes (42)

• Change from baseline (standard tookit condition) in fasting blood glucose under the portion-control toolkit condition

  Clinical Investigation Day 1, Clinical Investigation Day 2

• Change from baseline (standard tookit condition) in fasting blood insulin under the portion-control toolkit condition

  Clinical Investigation Day 1, Clinical Investigation Day 2

• Change from baseline (standard tookit condition) in fasting blood pancreatic polypeptide under the portion-control toolkit condition

  Clinical Investigation Day 1, Clinical Investigation Day 2

Study Arms (2)

Standard serving utensil toolkit

ACTIVE COMPARATOR

Participants will self-serve and condiment a cold meal in the laboratory using standard kitchen utensils, including 2 nylon serving spoons and a simple glass oil dispenser. Participants will complete an eye-tracking test before eating, and will fill in questionnaires and provide blood samples during and after the meal. At 2h post-meal, they will complete a computerized memory reconstruction task related to the meal. After leaving the laboratory participants will keep a food diary, and will complete an on-line learning test before bedtime.

Device: Standard serving utensil toolkit

Optimised portion-control toolkit

EXPERIMENTAL

Participants will self-serve and condiment a cold meal in the laboratory using an optimised portion control toolkit. This toolkit will include two calibrated serving spoons, one for vegetables (slotted) and one for starch (solid), and a calibrated oil dispenser. Both spoons have a volume capacity of 155 ml with a 121 ml mark. The oil dispenser has a volume capacity of 250ml and allows pre-portioning of the oil via a sucking device in amounts ranging from 5-20 millilitres, 1-3 teaspoons or 0.5 to 1 tablespoon, prior to serving. Participants will complete an eye-tracking test before eating, and will fill in questionnaires and provide blood samples during and after the meal. At 2h post-meal, they will complete a computerized memory reconstruction task related to the meal. After leaving the laboratory participants will keep a food diary, and will complete an on-line learning test before bedtime.

Device: Optimsed portion-control toolkit

Interventions

Standard serving utensil toolkit DEVICE

Serving a meal using standard kitchen utensils (100% of subjects experiment with these tools first)

Also known as: Standard serving spoon set and standard oil dispenser

Standard serving utensil toolkit

Optimsed portion-control toolkit DEVICE

Serving a meal using optimised, portion-control utensils (100% of subjects experiment with these tools second)

Also known as: Calibrated serving spoon set and calibrated oil dispenser

Optimised portion-control toolkit

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Clinica Universidad de Navarra, Universidad de Navarra: lead
• University of Bristol: collaborator
• University of Roma La Sapienza: collaborator

Study Sites (1)

University of Navarra, Dept. of Food Science and Physiology, Center for Nutrition Research

Pamplona, Navarre, 31008, Spain

Location

MeSH Terms

Conditions

Overweight; Obesity

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Eva Almiron-Roig, PhD

  University of Navarra

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The study will be advertised as research on practical strategies to facilitate a balanced and healthy diet.
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The study involves two stages. During stage 1 (control condition) all participants will use conventional kitchen utensils to self-serve and condiment a laboratory meal. During stage 2 (experimental condition) all participants will use an experimental set of tools to self-serve and condiment the same meal as in stage 1. The two stages will always follow the same order, control first and then experimental. The before and after design was chosen as the study aims to explore the acute effect of the implementation of portion control utensils in the same individual, avoiding carry-over effects due to learning from using the experimental tool.

Study Record Dates

• First Submitted: October 24, 2022
• First Posted: November 16, 2022
• Study Start: November 9, 2022
• Primary Completion: June 12, 2023
• Study Completion: June 16, 2023
• Last Updated: May 9, 2024

Record last verified: 2023-11

Locations

ES (1)