Effect of a Novel Protein Ingredient Combined With Oral Nutritional Supplement on Appetite in Older Adults

NCT06478147 | Active Not Recruiting

• 1 other identifier: LS-22-64-Horner#2
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

Brief Summary

Reduced appetite can occur with ageing and is linked to a higher risk of undernutrition, poorer physical function and becoming frail. Strategies to increase appetite are needed to improve healthy ageing. This study follows on from previous work which has found a novel ingredient in whey protein (derived from whole milk) that may help to increase appetite and energy intake. This study will compare the effects of the ingredient added to an oral nutritional supplement (ONS) versus the ONS alone versus the ingredient dissolved in water on appetite in older adults. By studying this nutrition supplement in older adults, this will help to provide greater information on possible nutrition strategies to improve healthy ageing.

Conditions

Aging; Appetite Loss; Undernutrition

Keywords

Appetite; Poor Appetite; Ageing; Whey protein hydrolysate; Visual analogue scale; Energy intake; Ghrelin; Oral Nutritional Supplement; Dairy

Outcome Measures

Primary Outcomes (2)

• Pre-meal and changes in Hunger

  Validated 100-millimetre Visual Analogue Scales (VAS) will be used to assess hunger, at ten (10) set time points throughout the experimental visit. This VAS has anchors located at each end of the scale. On the left end of the scale, the extreme negative response (0 mm) is represented, while the right end (100 mm) represents the positive response. Participants mark along the line where it most represents their subjective perception between both ends. Hunger is directly obtained from its VAS rating. Changes between fast and post-meal, mean and AUC values will be calculated.

  9.5 hours: fast (pre-ONS), pre-breakfast: 90 (post-ONS), 60, 30 and 0 min; post-breakfast: 0 and 180 min (pre-lunch); post-lunch: 0 and 90 min (pre-ONS); 0 min post-ONS; estimated 120 min. post-ONS (pre-dinner); 0 min. post-dinner

• Energy Intake (EI) from an ad libitum breakfast meal (kilocalories)

  First meal (ad libitum breakfast) energy intake measurement. Participants will be served a standardised ad libitum breakfast in the laboratory. EI (kilocalories) will be measured objectively, by weighing foods before and after consumption and calculating energy intake based on their nutritional data.

  Measures taken immediately following the ad libitum test meal (a single measurement)

Secondary Outcomes (20)

• Palatability - Pleasantness

  9.5 hours: mean of ratings taken immediately following the three test meals and the two intakes of the test supplement (single measure), i.e., supplement, breakfast, lunch, supplement, dinner

• Palatability - Filling

  9.5 hours: mean of ratings taken immediately following the three test meals and the two intakes of the test supplement (single measure), i.e., supplement, breakfast, lunch, supplement, dinner

• Palatability - Satisfaction

  9.5 hours: mean of ratings taken immediately following the three test meals and the two intakes of the test supplement (single measure), i.e., supplement, breakfast, lunch, supplement, dinner

• Palatability - Taste

  9.5 hours: mean of ratings taken immediately following the three test meals and the two intakes of the test supplement (single measure), i.e., supplement, breakfast, lunch, supplement, dinner

• Palatability - Sweet

  9.5 hours: mean of ratings taken immediately following the three test meals and the two intakes of the test supplement (single measure), i.e., supplement, breakfast, lunch, supplement, dinner

Study Arms (3)

Oral Nutritional Supplement

PLACEBO COMPARATOR

125 mL of commercially available of Oral Nutritional Supplement, a liquid food product containing vitamins, minerals, protein, fats and carbohydrates. 125 mL of product provides 37.0 g of carbohydrates, 11.6 g of fats, 12.0 g of proteins, vitamins and minerals.

Dietary Supplement: Oral Nutritional Supplement

Oral Nutritional Supplement + Whey Protein Hydrolysate

EXPERIMENTAL

2,2 grams of whey protein hydrolysate dissolved in 125 mL of commercially available of Oral Nutritional Supplement

Dietary Supplement: Oral Nutritional Supplement + Whey Protein Hydrolysate

Whey Protein Hydrolysate

ACTIVE COMPARATOR

2,2 grams of whey protein hydrolysate dissolved in 125 mL of water

Dietary Supplement: Whey Protein Hydrolysate + still water

Interventions

Oral Nutritional Supplement DIETARY_SUPPLEMENT

Commercially available Oral Nutritional Supplement alone consumed 90 minutes prior to an ad libitum breakfast

Oral Nutritional Supplement

Oral Nutritional Supplement + Whey Protein Hydrolysate DIETARY_SUPPLEMENT

Whey Protein Hydrolysate dissolved in an Oral Nutritional Supplement consumed 90 minutes prior to an ad libitum breakfast

Oral Nutritional Supplement + Whey Protein Hydrolysate

Whey Protein Hydrolysate + still water DIETARY_SUPPLEMENT

Whey Protein Hydrolysate dissolved in still water consumed 90 minutes prior to an ad libitum breakfast

Whey Protein Hydrolysate

Eligibility Criteria

• Age: 60 Years - 120 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Community-dwelling,
• Age 60+ years
• Poor appetite (Simplified Nutritional Appetite Questionnaire (SNAQ) score \</=14, answer a, b or c to Q.1 on SNAQ or answer b, c, or d to CES-D question regarding poor appetite in the past week)
• BMI 20-25kg/m2

You may not qualify if:

• Current medical condition or medication known to impact appetite or energy intake
• Other medical condition that would impact study participation and outcomes, as judged by the study investigator.
• Heavy smoker (\>10/day)
• Inability to come to study centre
• Currently participating in another intervention study
• Lacking informed consent
• Allergic to or unwilling to consume any of the study test foods
• Loss of taste or smell associated with COVID-19
• Unable to walk across a room

Sponsors & Collaborators

• University College Dublin: lead
• FHI 360: collaborator

Study Sites (1)

University College Dublin

Dublin, Leinster, D04 V1W8, Ireland

Location

MeSH Terms

Conditions

Anorexia; Malnutrition

Interventions

Dietary Supplements

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Nutrition Disorders; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Out of three treatments, one of the investigators is blinded for all treatments while the other is not blinded. The participant is fully blinded, i.e. treatments will be served in generic containers for Oral Nutritional Supplement (unlabelled) and vanilla-flavoured.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer in Sport and Exercise Science

Model Details: Crossover Assignment All participants undertake all three experimental conditions in a random order.

Study Record Dates

• First Submitted: November 23, 2023
• First Posted: June 27, 2024
• Study Start: December 2, 2023
• Primary Completion: April 28, 2024
• Study Completion: June 29, 2024
• Last Updated: June 27, 2024

Record last verified: 2024-06

Locations

IE (1)