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Completed

NCT Number: NCT04521374

The Effects of Texture Modified Diets on Dietary Intake and Appetite Responses in Older Adults

This study aims to investigate the effects of equicaloric texture modified and regular meals that are either fortified with protein or not on dietary intake and satiety in older adults (65+) living in the United Kingdom (UK).

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Key information

Conditions

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Reading

Reading, United Kingdom

About this study

  • To investigate whether there are any differences in appetite responses following a texture modified meal compared to a standard meal.
  • To investigate whether protein-enriched versions of a texture modified meal and/or standard meal affects satiety and subsequent intake in healthy older adults.
  • To investigate the effects of a texture modified diet, standard diet and their protein-enriched versions on gastric emptying in healthy older adults.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • aged 65 years or over (no upper age limit);
  • be within body mass index range (18.5-34.9kg/m2 );
  • regularly consume 3 meals a day (breakfast by 11am, lunch and dinner);
  • be able to accept test meals provided;
  • be able to feed themselves;
  • be able to give informed consent; i.e not lacking mental capacity;
  • Have access to a kitchen, freezer and fridge.
  • Have access to a telephone.
  • understand English.

Exclusion criteria

  • Diagnosed with coronavirus (COVID-19) or have had it in the last 4 weeks.
  • have any existing neurological or gastrointestinal condition;
  • have Cancer;
  • have no current chewing or swallowing difficulties (such as dysphagia);
  • have no existing cognitive or psychiatric disorder;
  • taking medications that can significantly affect taste changes, appetite or gastric emptying;
  • be on a special or therapeutic diet;
  • have any food allergies or intolerances that will be worsened with meals provided in the study;
  • have a history of drug or alcohol misuse;
  • smoke more than 10 cigarettes a day.

Treatment and study plan

Preload meals that are solid or texture modified and are fortified with protein or not fortified with protein

Behavioral

Immediately after consuming the preload meal, volunteers will use a 100mm visual analogue scale (VAS) to rate their liking towards the meal, their hunger, fullness, desire to eat and prospective food intake. Subsequently, they will record these every 30 minutes until they consume their ad-libitum dinner

Primary outcomes

  1. Intake at ad-libitum dinner

    Time frame: 4 days in total (one measurement per study day)

    Intake at the ad-libitum meal is measured (grams). Volunteers are instructed to eat only until they feel comfortable satisfied and are given 20 min to consume the meal.

Secondary outcomes

  1. Ratings (Appetite, hedonic and palatability) of breakfast, preload lunch and ad-libitum dinner

    Time frame: Regular ratings each study visit, 4 days in total

    Appetite, hedonic and palatability ratings are assessed using validated 100 mm Visual Analogue Scales (VAS, sscale 0-100). Before and immediately after breakfast and assessed every 30 min for 360 min

  2. Gastric emptying

    Time frame: Regular samples each study visit, 4 days in total

    Gastric emptying will be measured using 13C-labelled sodium acetate which will be added into a bottle of water. This will be consumed alongside preload meal. Measurements will be taken every 1 hour after consumption of breakfast up to preload, then every 15 min after the preload for 180 min.

Sponsors and collaborators

Lead sponsor

University of Reading

Other

Registry information

Official study title

Investigating the Influence of Texture Modified and Protein-enriched Meals on Dietary Intake and Appetite Responses in Healthy Older Adults

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Aug 20, 2020
Registry last updated
Oct 21, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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