Appetitive BehaviorNCT05507801
Protein and Satiety in Older Adults (PROSAT)
A study testing High Protein Milkshake and Normal Milkshake in people with Appetitive Behavior and Gastric Emptying, run by University of Reading at 1 site in United Kingdom.
Trial summary
This study aims to assess the effect of protein on appetite, food intake and gastric emptying in older adults (≥ 65 years) that are more and less active. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Appetitive Behavior, Gastric Emptying, Physical Activity
- What is being tested?
- High Protein Milkshake and Normal Milkshake
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 19 Nov 2021to 23 Aug 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- healthy
- aged ≥ 65 years
Who cannot join
- having diabetes or disability or any disease that are likely to influence physical activity or appetite.
- having an allergy to any of the test foods;
- disliking or cannot eat any of the test foods;
- being obese (BMI > 30 kg/m2);
- taking medications known to influence appetite, food intake or body weight in the past three months;
- being on a weight loss diet;
- smoking more than 10 cigarettes a day;
- not meeting the cut-off point criteria based on the accelerometer data (108.25 ≤ min/per day of moderate and vigorous activity for women or 162 ≥ min/per day moderate and vigorous activity for women and 100.1 ≤ min/per day of moderate and vigorous activity for men or 133.25 ≥ min/per day moderate and vigorous activity for men).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Protein on Appetite and Food Intake in More and Less Active Older Adults.
This study aims to assess the effect of protein on appetite, food intake and gastric emptying in older adults (≥ 65 years) that are more and less active.
Read the detailed description
To investigate the differences in food intake in older adults that are more or less active and assess any differential responses to protein intake.
To compare the effect of meals with high or low protein level but equal in energy and volume on appetite and gastric emptying in older adults that are more or less active (≥ 65 years).
- Being tested
- High Protein Milkshake, Normal Milkshake
- Keywords
- protein, physical activity, older adults, appetite, energy intake, satiety
- Medical subject headings
- Appetitive Behavior, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High Protein MilkshakeOther
A milkshake with high protein level; including whey protein, fat free strawberry yogurt and whole milk - 337 kcal, 27 g carbohydrate, 57 g protein, 16 g fat.
Normal MilkshakeOther
A milkshake with normal protein level; including nesquik (strawberry), fat free strawberry yogurt, whole milk, double cream, whey protein and sweetener - 331 kcal, 64 g carbohydrate, 17 g protein, 19 g fat.
| Study group | Role | What they receive |
|---|---|---|
| High Physically Active Group | Experimental | Based on accelerometer data, women with 162 ≥ min/per day moderate and vigorous activity or men 133.25 ≥ min/per day moderate and vigorous activity. Receives: Other: High Protein Milkshake; Other: Normal Milkshake |
| Low Physically Active Group | Experimental | Based on accelerometer data, women with 108.25 ≤ min/per day moderate and vigorous activity or men 100.1 ≤ min/per day moderate and vigorous activity. Receives: Other: High Protein Milkshake; Other: Normal Milkshake |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ad-libitum meal consumption
Consumption of the ad-libitum meal is measured (g). Participants are instructed to eat until they feel comfortable full and are given 20 min to consume the meal.
Measured: 2 days in total
Secondary outcomes (3)
Ratings of appetite
Appetite are assessed using a 100 mm Visual Analogue Scales (VAS, scale 0-100).
Measured: 2 days in total
Gastric Emptying
Gastric emptying is measured using of 100 microliters of 13C Octanoic Acid breath test
Measured: 2 days in total
Ratings of palatability
Palatability ratings are assessed using a 100 mm Visual Analogue Scales (VAS, scale 0-100).
Measured: 2 days in total
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2022
- Study start19 Nov 2021
- Primary completion23 Aug 2022
- Study completion23 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Appetitive BehaviorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Reading
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of National Education, Turkey
- Responsible party
- Principal investigator, Miriam Clegg, University of Reading
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05507801
- Sponsor's protocol ID
- UREC 21/40
- Status last verified
- Jun 2024
- First submitted
- 11 Aug 2022
- Last updated
- 7 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No personal identification data will be shared. The study is not under an obligation to share data, however, it is possible that some of the individual (unliked / non-identifiable) data will be useful in a meta-analysis and, hence sharing individual participant data (IPD) will be considered.
Publications
Deutz NE, Bauer JM, Barazzoni R, Biolo G, Boirie Y, Bosy-Westphal A, Cederholm T, Cruz-Jentoft A, Krznaric Z, Nair KS, Singer P, Teta D, Tipton K, Calder PC. Protein intake and exercise for optimal muscle function with aging: recommendations from the ESPEN Expert Group. Clin Nutr. 2014 Dec;33(6):929-36. doi: 10.1016/j.clnu.2014.04.007. Epub 2014 Apr 24.
PubMed 24814383Morell P, Fiszman S. Revisiting the role of protein-induced satiation and satiety. Food Hydrocolloids. 2017 Jul 1;68:199-210.
Timiras PS. Physiological basis of aging and geriatrics, CRC Press. 2022
Ahmed T, Haboubi N. Assessment and management of nutrition in older people and its importance to health. Clin Interv Aging. 2010 Aug 9;5:207-16. doi: 10.2147/cia.s9664.
PubMed 20711440St-Onge MP, Gallagher D. Body composition changes with aging: the cause or the result of alterations in metabolic rate and macronutrient oxidation? Nutrition. 2010 Feb;26(2):152-5. doi: 10.1016/j.nut.2009.07.004. Epub 2009 Dec 8.
PubMed 20004080Margetts BM, Thompson RL, Elia M, Jackson AA. Prevalence of risk of undernutrition is associated with poor health status in older people in the UK. Eur J Clin Nutr. 2003 Jan;57(1):69-74. doi: 10.1038/sj.ejcn.1601499.
PubMed 12548299Giezenaar C, Trahair LG, Luscombe-Marsh ND, Hausken T, Standfield S, Jones KL, Lange K, Horowitz M, Chapman I, Soenen S. Effects of randomized whey-protein loads on energy intake, appetite, gastric emptying, and plasma gut-hormone concentrations in older men and women. Am J Clin Nutr. 2017 Sep;106(3):865-877. doi: 10.3945/ajcn.117.154377. Epub 2017 Jul 26.
PubMed 28747330
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Protein on Appetite and Food Intake in More and Less Active Older Adults.
- ClinicalTrials.gov ID
- NCT05507801
- Acronym / sponsor ID
- UREC 21/40
- Keywords
- protein, physical activity, older adults, appetite, energy intake, satiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- University of ReadingUniversity, hospital or other
- Collaborators
- Ministry of National Education, Turkey
- Study start
- 19 Nov 2021 (actual)
- Primary completion
- 23 Aug 2022 (actual)
- Study completion
- 23 Aug 2022 (actual)
- First posted
- 19 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to assess the effect of protein on appetite, food intake and gastric emptying in older adults (≥ 65 years) that are more and less active.
Detailed description
To investigate the differences in food intake in older adults that are more or less active and assess any differential responses to protein intake.
To compare the effect of meals with high or low protein level but equal in energy and volume on appetite and gastric emptying in older adults that are more or less active (≥ 65 years).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High Physically Active Group | Experimental | Other: High Protein Milkshake, Other: Normal MilkshakeBased on accelerometer data, women with 162 ≥ min/per day moderate and vigorous activity or men 133.25 ≥ min/per day moderate and vigorous activity. |
| Low Physically Active Group | Experimental | Other: High Protein Milkshake, Other: Normal MilkshakeBased on accelerometer data, women with 108.25 ≤ min/per day moderate and vigorous activity or men 100.1 ≤ min/per day moderate and vigorous activity. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- healthy
- aged ≥ 65 years
Key exclusion criteria (8 listed)
- having diabetes or disability or any disease that are likely to influence physical activity or appetite.
- having an allergy to any of the test foods;
- disliking or cannot eat any of the test foods;
- being obese (BMI > 30 kg/m2);
- taking medications known to influence appetite, food intake or body weight in the past three months;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High Protein MilkshakeA milkshake with high protein level; including whey protein, fat free strawberry yogurt and whole milk - 337 kcal, 27 g carbohydrate, 57 g protein, 16 g fat. | Other | High Physically Active Group, Low Physically Active Group |
| Normal MilkshakeA milkshake with normal protein level; including nesquik (strawberry), fat free strawberry yogurt, whole milk, double cream, whey protein and sweetener - 331 kcal, 64 g carbohydrate, 17 g protein, 19 g fat. | Other | High Physically Active Group, Low Physically Active Group |
Primary outcome
Ad-libitum meal consumption
Time frame: 2 days in total
Consumption of the ad-libitum meal is measured (g). Participants are instructed to eat until they feel comfortable full and are given 20 min to consume the meal.
3 secondary outcomes
Ratings of appetite
Time frame: 2 days in total
Gastric Emptying
Time frame: 2 days in total
Ratings of palatability
Time frame: 2 days in total
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2024.
- Background: PubMed 24814383Deutz NE, Bauer JM, Barazzoni R, Biolo G, Boirie Y, Bosy-Westphal A, Cederholm T, Cruz-Jentoft A, Krznaric Z, Nair KS, Singer P, Teta D, Tipton K, Calder PC. Protein intake and exercise for optimal muscle function with aging: recommendations from the ESPEN Expert Group. Clin Nutr. 2014 Dec;33(6):929-36. doi: 10.1016/j.clnu.2014.04.007. Epub 2014 Apr 24.
- BackgroundMorell P, Fiszman S. Revisiting the role of protein-induced satiation and satiety. Food Hydrocolloids. 2017 Jul 1;68:199-210.
- BackgroundTimiras PS. Physiological basis of aging and geriatrics, CRC Press. 2022
- Background: PubMed 20711440Ahmed T, Haboubi N. Assessment and management of nutrition in older people and its importance to health. Clin Interv Aging. 2010 Aug 9;5:207-16. doi: 10.2147/cia.s9664.
- Background: PubMed 20004080St-Onge MP, Gallagher D. Body composition changes with aging: the cause or the result of alterations in metabolic rate and macronutrient oxidation? Nutrition. 2010 Feb;26(2):152-5. doi: 10.1016/j.nut.2009.07.004. Epub 2009 Dec 8.
- Background: PubMed 12548299Margetts BM, Thompson RL, Elia M, Jackson AA. Prevalence of risk of undernutrition is associated with poor health status in older people in the UK. Eur J Clin Nutr. 2003 Jan;57(1):69-74. doi: 10.1038/sj.ejcn.1601499.
- Background: PubMed 28747330Giezenaar C, Trahair LG, Luscombe-Marsh ND, Hausken T, Standfield S, Jones KL, Lange K, Horowitz M, Chapman I, Soenen S. Effects of randomized whey-protein loads on energy intake, appetite, gastric emptying, and plasma gut-hormone concentrations in older men and women. Am J Clin Nutr. 2017 Sep;106(3):865-877. doi: 10.3945/ajcn.117.154377. Epub 2017 Jul 26.
- Healthy eating overview-Maintaining a healthy weight.Link provided by the sponsor.
- Exercise as you get older.Link provided by the sponsor.
- Individual participant dataSharing planned: No. No personal identification data will be shared. The study is not under an obligation to share data, however, it is possible that some of the individual (unliked / non-identifiable) data will be useful in a meta-analysis and, hence sharing individual participant data (IPD) will be considered.
Related trials for Appetitive Behavior
Active, not recruitingObservational study
Appetitive Conditioning in Anorexia Nervosa
Anorexia Nervosa
Recruiting
Behavioral Approach for Latinas Addressing Nutrition, Cravings, and Eating Patterns to Prevent Type 2 Diabetes
Prediabetes, Obesity (Body Mass Index >30 kg/m2)
Recruiting
Validation of a Novel Cerebellar-striatal Satiety Circuit in Humans
Appetitive Behavior, Obesity
Recruiting
Exercise, Brain Activity, and Weight Maintenance
Obesity, Weight Gain
RecruitingPhase 4
Metabolic and Behavioural Effects of CONTRAVE as Potential Mechanisms of Weight Loss in Adults With Obesity
Obesity, Weight Loss
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High Protein Milkshake and Normal Milkshake in people with Appetitive Behavior and Gastric Emptying, run by University of Reading at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ad-libitum meal consumption (time frame: 2 days in total). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05507801, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jun 2024.