Appetitive BehaviorMACROSATNCT04623450
Macronutrients and Satiety in Older and Younger Adults
A study testing Smoothie 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 compare the effect of meals high in protein, fat and carbohydrate but equal in energy and volume on energy intake, perceived appetite and gastric emptying in younger (<40 years) and older (> 65 years) people living in the United Kingdom (UK). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Appetitive Behavior, Gastric Emptying
- What is being tested?
- Smoothie
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 5 May 2019to 9 Sep 2021
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- either aged >65 years or <40 years
- healthy
Who cannot join
- having a disease and/or using a medication that can impact on appetite in the past three months;
- having an allergy to any of the test foods;
- disliking or cannot eat any of the test foods;
- being pregnant or breastfeeding;
- being obese (BMI > 30 kg/m2);
- being on a weight loss diet;
- smoking more than 10 cigarettes a day.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
University of Reading
Reading
Miriam Clegg, BSc, PhD, +44 (0)118 378 8723, m.e.clegg@reading.ac.uk
Lisa Methven, BSc, PhD, +44 (0)118 378 8714, l.methven@reading.ac.uk
About this study
Official title: The Effect of Different Macronutrients on Appetite and Satiety in Older and Younger Adults
This study aims to compare the effect of meals high in protein, fat and carbohydrate but equal in energy and volume on energy intake, perceived appetite and gastric emptying in younger (<40 years) and older (> 65 years) people living in the United Kingdom (UK).
Read the detailed description
To assess if increasing protein intake in older adults will have a compensatory decrease in energy intake due to protein's satiating effects.
To compare the effect of meals high in protein, fat and carbohydrate but equal in energy and volume on energy intake and perceived appetite in younger (<40 years) and older adults (>65 years).
To compare the effect of meals high in protein, fat and carbohydrate but equal in energy and volume on gastric emptying in younger (<40 years) and older adults (>65 years).
- Conditions
- Appetitive Behavior, Gastric Emptying
- Being tested
- Smoothie
- Keywords
- younger adults, older adults, appetite, satiety, macronutrients
- Medical subject headings
- Appetitive Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SmoothieOther
Preload smoothies that are matched for taste, smell, appearance, quantity and calorie but different caloric content.
| Study group | Role | What they receive |
|---|---|---|
| High Carbohydrate Meal | Experimental | A smoothie including maltodextrin and low-fat strawberry yoghurt - 289 kcal, 61g carbohydrate, 6.7g protein, 1.9g fat. Receives: Other: Smoothie |
| High Fat Meal | Experimental | A smoothie including double cream and low-fat strawberry yoghurt - 312 kcal, 13.3g carbohydrate, 7g protein, 25.5g fat. Receives: Other: Smoothie |
| High Protein Meal | Experimental | A smoothie including whey protein and low-fat strawberry yoghurt - 307 kcal, 13.6g carbohydrate, 57g protein, 2.7g fat. Receives: Other: Smoothie |
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: 3 days in total
Secondary outcomes (3)
Ratings of appetite
Appetite are assessed using a 100 mm Visual Analogue Scales (VAS, scale 0-100).
Measured: 3 days in total
Gastric Emptying
Gastric emptying is measured using of 13C octanoic acid breath test
Measured: 3 days in total
Ratings of palatability
Palatability ratings are assessed using a 100 mm Visual Analogue Scales (VAS, scale 0-100).
Measured: 3 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 posted10 Nov 2020
- Study start5 May 2019
- Primary completion7 Jun 2021 (estimated)
- Study completion9 Sep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)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
- 40 participants (estimated)
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
- NCT04623450
- Sponsor's protocol ID
- UREC 19/25
- Acronym
- MACROSAT
- Status last verified
- Nov 2020
- First submitted
- 28 Oct 2020
- Last updated
- 12 Nov 2020
- 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 24814383Clarkston WK, Pantano MM, Morley JE, Horowitz M, Littlefield JM, Burton FR. Evidence for the anorexia of aging: gastrointestinal transit and hunger in healthy elderly vs. young adults. Am J Physiol. 1997 Jan;272(1 Pt 2):R243-8. doi: 10.1152/ajpregu.1997.272.1.R243.
PubMed 9039015Blundell JE, Burley VJ, Cotton JR, Lawton CL. Dietary fat and the control of energy intake: evaluating the effects of fat on meal size and postmeal satiety. Am J Clin Nutr. 1993 May;57(5 Suppl):772S-777S; discussion 777S-778S. doi: 10.1093/ajcn/57.5.772S.
PubMed 8475895Rolls BJ, Kim-Harris S, Fischman MW, Foltin RW, Moran TH, Stoner SA. Satiety after preloads with different amounts of fat and carbohydrate: implications for obesity. Am J Clin Nutr. 1994 Oct;60(4):476-87. doi: 10.1093/ajcn/60.4.476.
PubMed 7661908Clegg ME, Williams EA. Optimizing nutrition in older people. Maturitas. 2018 Jun;112:34-38. doi: 10.1016/j.maturitas.2018.04.001. Epub 2018 Apr 4.
PubMed 29704915Giezenaar 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 28747330Appleton KM. Limited compensation at the following meal for protein and energy intake at a lunch meal in healthy free-living older adults. Clin Nutr. 2018 Jun;37(3):970-977. doi: 10.1016/j.clnu.2017.03.032. Epub 2017 Apr 7.
PubMed 28431774Beelen J, de Roos NM, de Groot LC. Protein Enrichment of Familiar Foods as an Innovative Strategy to Increase Protein Intake in Institutionalized Elderly. J Nutr Health Aging. 2017;21(2):173-179. doi: 10.1007/s12603-016-0733-y.
PubMed 28112772
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Different Macronutrients on Appetite and Satiety in Older and Younger Adults
- ClinicalTrials.gov ID
- NCT04623450
- Acronym / sponsor ID
- MACROSAT / UREC 19/25
- Conditions
- Appetitive Behavior, Gastric Emptying
- Keywords
- younger adults, older adults, appetite, satiety, macronutrients
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of ReadingUniversity, hospital or other
- Collaborators
- Ministry of National Education, Turkey
- Study start
- 5 May 2019 (actual)
- Primary completion
- 7 Jun 2021 (estimated)
- Study completion
- 9 Sep 2021 (estimated)
- First posted
- 10 Nov 2020 (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 compare the effect of meals high in protein, fat and carbohydrate but equal in energy and volume on energy intake, perceived appetite and gastric emptying in younger (<40 years) and older (> 65 years) people living in the United Kingdom (UK).
Detailed description
To assess if increasing protein intake in older adults will have a compensatory decrease in energy intake due to protein's satiating effects.
To compare the effect of meals high in protein, fat and carbohydrate but equal in energy and volume on energy intake and perceived appetite in younger (<40 years) and older adults (>65 years).
To compare the effect of meals high in protein, fat and carbohydrate but equal in energy and volume on gastric emptying in younger (<40 years) and older adults (>65 years).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| High Carbohydrate Meal | Experimental | Other: SmoothieA smoothie including maltodextrin and low-fat strawberry yoghurt - 289 kcal, 61g carbohydrate, 6.7g protein, 1.9g fat. |
| High Fat Meal | Experimental | Other: SmoothieA smoothie including double cream and low-fat strawberry yoghurt - 312 kcal, 13.3g carbohydrate, 7g protein, 25.5g fat. |
| High Protein Meal | Experimental | Other: SmoothieA smoothie including whey protein and low-fat strawberry yoghurt - 307 kcal, 13.6g carbohydrate, 57g protein, 2.7g fat. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- either aged >65 years or <40 years
- healthy
Key exclusion criteria (7 listed)
- having a disease and/or using a medication that can impact on appetite in the past three months;
- having an allergy to any of the test foods;
- disliking or cannot eat any of the test foods;
- being pregnant or breastfeeding;
- being obese (BMI > 30 kg/m2);
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 |
|---|---|---|
| SmoothiePreload smoothies that are matched for taste, smell, appearance, quantity and calorie but different caloric content. | Other | High Carbohydrate Meal, High Fat Meal, High Protein Meal |
Primary outcome
Ad-libitum meal consumption
Time frame: 3 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: 3 days in total
Gastric Emptying
Time frame: 3 days in total
Ratings of palatability
Time frame: 3 days in total
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2020.
- 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.
- Background: PubMed 9039015Clarkston WK, Pantano MM, Morley JE, Horowitz M, Littlefield JM, Burton FR. Evidence for the anorexia of aging: gastrointestinal transit and hunger in healthy elderly vs. young adults. Am J Physiol. 1997 Jan;272(1 Pt 2):R243-8. doi: 10.1152/ajpregu.1997.272.1.R243.
- Background: PubMed 8475895Blundell JE, Burley VJ, Cotton JR, Lawton CL. Dietary fat and the control of energy intake: evaluating the effects of fat on meal size and postmeal satiety. Am J Clin Nutr. 1993 May;57(5 Suppl):772S-777S; discussion 777S-778S. doi: 10.1093/ajcn/57.5.772S.
- Background: PubMed 7661908Rolls BJ, Kim-Harris S, Fischman MW, Foltin RW, Moran TH, Stoner SA. Satiety after preloads with different amounts of fat and carbohydrate: implications for obesity. Am J Clin Nutr. 1994 Oct;60(4):476-87. doi: 10.1093/ajcn/60.4.476.
- Background: PubMed 29704915Clegg ME, Williams EA. Optimizing nutrition in older people. Maturitas. 2018 Jun;112:34-38. doi: 10.1016/j.maturitas.2018.04.001. Epub 2018 Apr 4.
- 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.
- Background: PubMed 28431774Appleton KM. Limited compensation at the following meal for protein and energy intake at a lunch meal in healthy free-living older adults. Clin Nutr. 2018 Jun;37(3):970-977. doi: 10.1016/j.clnu.2017.03.032. Epub 2017 Apr 7.
- Background: PubMed 28112772Beelen J, de Roos NM, de Groot LC. Protein Enrichment of Familiar Foods as an Innovative Strategy to Increase Protein Intake in Institutionalized Elderly. J Nutr Health Aging. 2017;21(2):173-179. doi: 10.1007/s12603-016-0733-y.
- 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.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Smoothie 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 7 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: status not confirmed, as of the sponsor's last update on 12 Nov 2020. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Miriam Clegg, BSc, PhD (+44 (0)118 378 8723, m.e.clegg@reading.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ad-libitum meal consumption (time frame: 3 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 NCT04623450, which also lists 8 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 12 Nov 2020.