AgingNCT05871060
Effect of a Novel Protein Supplement on Appetite in Older Adults
A study testing Whey Protein Concentrate and Whey hydrolysate in people with Aging and Appetite Loss, run by University College Dublin at 1 site in Ireland.
Trial summary
An acute randomized crossover trial comparing the effects of the whey hydrolysate, whey protein concentrate and placebo (still flavored water) on appetite and energy intake in older adults. Both low-dose whey-derived treatment and placebo will be administered 30 minutes prior to breakfast and lunch meals. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Aging, Appetite Loss
- What is being tested?
- Whey Protein Concentrate and Whey hydrolysate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 14 participants
- Where
- 1 siteIreland
- Study dates
- 25 Apr 2023to 30 Oct 2023
- 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 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
An acute randomized crossover trial comparing the effects of the whey hydrolysate, whey protein concentrate and placebo (still flavored water) on appetite and energy intake in older adults. Both low-dose whey-derived treatment and placebo will be administered 30 minutes prior to breakfast and lunch meals. Moreover, ghrelin secretion and activity will be monitored throughout the morning until the lunch time. Appetite will be assessed through visual analogue scale questionnaires.
- Conditions
- Aging, Appetite Loss
- Being tested
- Whey Protein Concentrate, Placebo, Whey hydrolysate
- Keywords
- Appetite, Poor Appetite, Ageing, Whey protein hydrolysate, Visual analogue scale, Energy intake, Ghrelin
- Medical subject headings
- Anorexia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Whey Protein ConcentrateDietary supplement
Whey protein concentrate consumed 30 minutes prior to breakfast and lunch meals
PlaceboDietary supplement
Flavoured water consumed 30 minutes prior to breakfast and lunch meals
Whey hydrolysateDietary supplement
Whey hydrolysate consumed 30 minutes prior to breakfast and lunch meals
| Study group | Role | What they receive |
|---|---|---|
| whey concentrate supplement | Active comparator | 2,2 grams of whey concentrate dissolved in 100 mL of water Receives: Dietary Supplement: Whey Protein Concentrate |
| whey hydrolysate supplement | Experimental | 2,2 grams of whey hydrolysate dissolved in 100 mL of water Receives: Dietary Supplement: Whey hydrolysate |
| still flavoured water | Placebo comparator | 100 mL of vanilla-flavoured water Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pre-meal and changes in Composite Appetite Score
Validated 100 millimetre Visual Analogue Scales (VAS) will be used to assess appetite, at fourteen (14) 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. Composite Appetite Score is derived from VAS ratings of hunger, fullness, desire to eat and prospective food consumption.
Measured: 8.5 hours: fasting, before breakfast, at 30, 60, 120, 180 and 210 minutes after ingestion of supplement and a standard meal; at 30, 60, 120 and 180 minutes following ingestion of supplement and lunch test meal. And immediately after each test meal.
Energy intake (EI) (kilocalories)
24-hour energy intake measurement. Participants will be served a standardised fixed breakfast and ad libitum lunch and dinner meals in the laboratory and provided with an evening snack box. 24 hour EI (kilocalories) will be measured objectively, by weighing foods before and after consumption and calculating energy intake based on their nutritional data. Total accumulated energy intake includes standard breakfast meal, ad libitum lunch meal, ad libitum dinner meal and bag with known foods for the evening time.
Measured: 24 hours from breakfast, lunch and dinner meals, as well as from evening and night from provided snackbox.
Secondary outcomes (19)
Palatability - Pleasantness
100 millimetre Visual Analogue Scales (VAS) will be used after each test meal: breakfast, lunch and dinner. This VAS has anchors located at each end of the scale. On the left end of the scale (0 mm), the extreme negative response 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.
Measured: Mean of ratings taken immediately following the three test meals (single measure) - breakfast, lunch and dinner
Palatability - Filling
100 millimetre Visual Analogue Scales (VAS) will be used after each test meal: breakfast, lunch and dinner. This VAS has anchors located at each end of the scale. On the left end of the scale (0 mm), the extreme negative response 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.
Measured: Mean of ratings taken immediately following the three test meals (single measure) - breakfast, lunch and dinner
Palatability - Satisfaction
100 millimetre Visual Analogue Scales (VAS) will be used after each test meal: breakfast, lunch and dinner. This VAS has anchors located at each end of the scale. On the left end of the scale (0 mm), the extreme negative response 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.
Measured: Mean of ratings taken immediately following the three test meals (single measure) - breakfast, lunch and dinner
Palatability - Taste
100 millimetre Visual Analogue Scales (VAS) will be used after each test meal: breakfast, lunch and dinner. This VAS has anchors located at each end of the scale. On the left end of the scale (0 mm), the extreme negative response 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.
Measured: Mean of ratings taken immediately following the three test meals (single measure) - breakfast, lunch and dinner
Palatability - Sweet
100 millimetre Visual Analogue Scales (VAS) will be used after each test meal: breakfast, lunch and dinner. This VAS has anchors located at each end of the scale. On the left end of the scale (0 mm), the extreme negative response 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.
Measured: Mean of ratings taken immediately following the three test meals (single measure) - breakfast, lunch and dinner
Palatability - Savoury
100 millimetre Visual Analogue Scales (VAS) will be used after each test meal: breakfast, lunch and dinner. This VAS has anchors located at each end of the scale. On the left end of the scale (0 mm), the extreme negative response 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.
Measured: Mean of ratings taken immediately following the three test meals (single measure) - breakfast, lunch and dinner
Pre-meal and changes in glucose
Blood samples will be collected by a trained phlebotomist via cannula.
Measured: 4 hours, from fasting state (morning) to immediately prior to lunch meal (afternoon): fasting, before breakfast, at 30, 60, 120, 180 and 210 minutes following ingestion of supplement
Pre-meal and changes in insulin
Blood samples will be collected by a trained phlebotomist via cannula.
Measured: 4 hours, from fasting state (morning) to immediately prior to lunch meal (afternoon): fasting, before breakfast, at 30, 60, 120, 180 and 210 minutes following ingestion of supplement
Pre-meal and changes in growth hormone
Blood samples will be collected by a trained phlebotomist via cannula.
Measured: 4 hours, from fasting state (morning) to immediately prior to lunch meal (afternoon): fasting, before breakfast, at 30, 60, 120, 180 and 210 minutes following ingestion of supplement
Pre-meal and changes in cortisol
Blood samples will be collected by a trained phlebotomist via cannula.
Measured: 4 hours, from fasting state (morning) to immediately prior to lunch meal (afternoon): fasting, before breakfast, at 30, 60, 120, 180 and 210 minutes following ingestion of supplement
Pre-meal and changes in GLP-1
Blood samples will be collected by a trained phlebotomist via cannula.
Measured: 4 hours, from fasting state (morning) to immediately prior to lunch meal (afternoon): fasting, before breakfast, at 30, 60, 120, 180 and 210 minutes following ingestion of supplement
Pre-meal and changes in PYY
Blood samples will be collected by a trained phlebotomist via cannula.
Measured: 4 hours, from fasting state (morning) to immediately prior to lunch meal (afternoon): fasting, before breakfast, at 30, 60, 120, 180 and 210 minutes following ingestion of supplement
Pre-meal and changes in Total Ghrelin
Blood samples will be collected by a trained phlebotomist via cannula.
Measured: 4 hours, from fasting state (morning) to immediately prior to lunch meal (afternoon): fasting, before breakfast, at 30, 60, 120, 180 and 210 minutes following ingestion of supplement
Pre-meal and changes in Acylated Ghrelin
Blood samples will be collected by a trained phlebotomist via cannula.
Measured: 4 hours, from fasting state (morning) to immediately prior to lunch meal (afternoon): fasting, before breakfast, at 30, 60, 120, 180 and 210 minutes following ingestion of supplement
Pre-meal and changes in Hunger
Validated 100 mm Visual Analogue Scales (VAS) will be used to estimate changes in appetite, assessed at fourteen (14) 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 (0 mm), the extreme negative response is represented, while the right end (100 mm) represents the extreme positive response. Participants mark along the line where it most represents their subjective perception between both ends. Composite Appetite Score derived from aspects such as hunger, fullness, desire to eat and prospective food consumption will be calculated. Fasting, mean and AUC values will be calculated.
Measured: 8.5 hours: fasting, before breakfast, at 30, 60, 120, 180 and 210 minutes following ingestion of supplement and a standard meal; at 30, 60, 120 and 180 minutes following ingestion of supplement and test meal.
Pre-meal and changes in Fullness
Validated 100 mm Visual Analogue Scales (VAS) will be used to estimate changes in appetite, assessed at fourteen (14) 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 (0 mm), the extreme negative response is represented, while the right end (100 mm) represents the extreme positive response. Participants mark along the line where it most represents their subjective perception between both ends. Composite Appetite Score derived from aspects such as hunger, fullness, desire to eat and prospective food consumption will be calculated. Fasting, mean and AUC values will be calculated.
Measured: 8.5 hours: fasting, before breakfast, at 30, 60, 120, 180 and 210 minutes following ingestion of supplement and a standard meal; at 30, 60, 120 and 180 minutes following ingestion of supplement and test meal.
Pre-meal and changes in Desire to Eat
Validated 100 mm Visual Analogue Scales (VAS) will be used to estimate changes in appetite, assessed at fourteen (14) 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 (0 mm), the extreme negative response is represented, while the right end (100 mm) represents the extreme positive response. Participants mark along the line where it most represents their subjective perception between both ends. Composite Appetite Score derived from aspects such as hunger, fullness, desire to eat and prospective food consumption will be calculated. Fasting, mean and AUC values will be calculated.
Measured: 8.5 hours: fasting, before breakfast, at 30, 60, 120, 180 and 210 minutes following ingestion of supplement and a standard meal; at 30, 60, 120 and 180 minutes following ingestion of supplement and test meal.
Pre-meal and changes in Prospective Food Consumption
Validated 100 mm Visual Analogue Scales (VAS) will be used to estimate changes in appetite, assessed at fourteen (14) 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 (0 mm), the extreme negative response is represented, while the right end (100 mm) represents the extreme positive response. Participants mark along the line where it most represents their subjective perception between both ends. Composite Appetite Score derived from aspects such as hunger, fullness, desire to eat and prospective food consumption will be calculated. Fasting, mean and AUC values will be calculated.
Measured: 8.5 hours: fasting, before breakfast, at 30, 60, 120, 180 and 210 minutes following ingestion of supplement and a standard meal; at 30, 60, 120 and 180 minutes following ingestion of supplement and test meal.
Liking of test meals
9-point likert scale from 0 dislike extremely to 9 like extremely
Measured: Mean of ratings taken immediately following the three test meals (single measure) - breakfast, lunch and dinner
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2023
- Study start25 Apr 2023
- Primary completion15 Sep 2023
- Study completion30 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AgingStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- All participants undertake all three experimental conditions in a random order.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- University College Dublin
- Sponsor type
- University, hospital or other
- Collaborators
- FHI 360
- Responsible party
- Principal investigator, Katy Horner, University College Dublin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05871060
- Sponsor's protocol ID
- LS-22-64-Horner
- Other IDs
- TC201800025
- Status last verified
- Nov 2023
- First submitted
- 31 Mar 2023
- Last updated
- 27 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a Novel Protein Supplement on Appetite in Older Adults
- ClinicalTrials.gov ID
- NCT05871060
- Acronym / sponsor ID
- LS-22-64-Horner
- Conditions
- Aging, Appetite Loss
- Keywords
- Appetite, Poor Appetite, Ageing, Whey protein hydrolysate, Visual analogue scale, Energy intake, Ghrelin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- University College DublinUniversity, hospital or other
- Collaborators
- FHI 360
- Study start
- 25 Apr 2023 (actual)
- Primary completion
- 15 Sep 2023 (actual)
- Study completion
- 30 Oct 2023 (actual)
- First posted
- 23 May 2023 (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.
An acute randomized crossover trial comparing the effects of the whey hydrolysate, whey protein concentrate and placebo (still flavored water) on appetite and energy intake in older adults. Both low-dose whey-derived treatment and placebo will be administered 30 minutes prior to breakfast and lunch meals. Moreover, ghrelin secretion and activity will be monitored throughout the morning until the lunch time. Appetite will be assessed through visual analogue scale questionnaires.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
- Model description
- All participants undertake all three experimental conditions in a random order.
| Arm | Type | Receives |
|---|---|---|
| whey concentrate supplement | Active comparator | Dietary Supplement: Whey Protein Concentrate2,2 grams of whey concentrate dissolved in 100 mL of water |
| whey hydrolysate supplement | Experimental | Dietary Supplement: Whey hydrolysate2,2 grams of whey hydrolysate dissolved in 100 mL of water |
| still flavoured water | Placebo comparator | Dietary Supplement: Placebo100 mL of vanilla-flavoured water |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- 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
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 |
|---|---|---|
| Whey Protein ConcentrateWhey protein concentrate consumed 30 minutes prior to breakfast and lunch meals | Dietary supplement | whey concentrate supplement |
| PlaceboFlavoured water consumed 30 minutes prior to breakfast and lunch meals | Dietary supplement | still flavoured water |
| Whey hydrolysateWhey hydrolysate consumed 30 minutes prior to breakfast and lunch meals | Dietary supplement | whey hydrolysate supplement |
Primary outcome
Pre-meal and changes in Composite Appetite Score
Time frame: 8.5 hours: fasting, before breakfast, at 30, 60, 120, 180 and 210 minutes after ingestion of supplement and a standard meal; at 30, 60, 120 and 180 minutes following ingestion of supplement and lunch test meal. And immediately after each test meal.
Validated 100 millimetre Visual Analogue Scales (VAS) will be used to assess appetite, at fourteen (14) 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. Composite Appetite Score is derived from VAS ratings of hunger, fullness, desire to eat and prospective food consumption.
Energy intake (EI) (kilocalories)
Time frame: 24 hours from breakfast, lunch and dinner meals, as well as from evening and night from provided snackbox.
24-hour energy intake measurement. Participants will be served a standardised fixed breakfast and ad libitum lunch and dinner meals in the laboratory and provided with an evening snack box. 24 hour EI (kilocalories) will be measured objectively, by weighing foods before and after consumption and calculating energy intake based on their nutritional data. Total accumulated energy intake includes standard breakfast meal, ad libitum lunch meal, ad libitum dinner meal and bag with known foods for the evening time.
19 secondary outcomes
Palatability - Pleasantness
Time frame: Mean of ratings taken immediately following the three test meals (single measure) - breakfast, lunch and dinner
Palatability - Filling
Time frame: Mean of ratings taken immediately following the three test meals (single measure) - breakfast, lunch and dinner
Palatability - Satisfaction
Time frame: Mean of ratings taken immediately following the three test meals (single measure) - breakfast, lunch and dinner
Palatability - Taste
Time frame: Mean of ratings taken immediately following the three test meals (single measure) - breakfast, lunch and dinner
Palatability - Sweet
Time frame: Mean of ratings taken immediately following the three test meals (single measure) - breakfast, lunch and dinner
Palatability - Savoury
Time frame: Mean of ratings taken immediately following the three test meals (single measure) - breakfast, lunch and dinner
Pre-meal and changes in glucose
Time frame: 4 hours, from fasting state (morning) to immediately prior to lunch meal (afternoon): fasting, before breakfast, at 30, 60, 120, 180 and 210 minutes following ingestion of supplement
Pre-meal and changes in insulin
Time frame: 4 hours, from fasting state (morning) to immediately prior to lunch meal (afternoon): fasting, before breakfast, at 30, 60, 120, 180 and 210 minutes following ingestion of supplement
Pre-meal and changes in growth hormone
Time frame: 4 hours, from fasting state (morning) to immediately prior to lunch meal (afternoon): fasting, before breakfast, at 30, 60, 120, 180 and 210 minutes following ingestion of supplement
Pre-meal and changes in cortisol
Time frame: 4 hours, from fasting state (morning) to immediately prior to lunch meal (afternoon): fasting, before breakfast, at 30, 60, 120, 180 and 210 minutes following ingestion of supplement
Pre-meal and changes in GLP-1
Time frame: 4 hours, from fasting state (morning) to immediately prior to lunch meal (afternoon): fasting, before breakfast, at 30, 60, 120, 180 and 210 minutes following ingestion of supplement
Pre-meal and changes in PYY
Time frame: 4 hours, from fasting state (morning) to immediately prior to lunch meal (afternoon): fasting, before breakfast, at 30, 60, 120, 180 and 210 minutes following ingestion of supplement
Pre-meal and changes in Total Ghrelin
Time frame: 4 hours, from fasting state (morning) to immediately prior to lunch meal (afternoon): fasting, before breakfast, at 30, 60, 120, 180 and 210 minutes following ingestion of supplement
Pre-meal and changes in Acylated Ghrelin
Time frame: 4 hours, from fasting state (morning) to immediately prior to lunch meal (afternoon): fasting, before breakfast, at 30, 60, 120, 180 and 210 minutes following ingestion of supplement
Pre-meal and changes in Hunger
Time frame: 8.5 hours: fasting, before breakfast, at 30, 60, 120, 180 and 210 minutes following ingestion of supplement and a standard meal; at 30, 60, 120 and 180 minutes following ingestion of supplement and test meal.
Pre-meal and changes in Fullness
Time frame: 8.5 hours: fasting, before breakfast, at 30, 60, 120, 180 and 210 minutes following ingestion of supplement and a standard meal; at 30, 60, 120 and 180 minutes following ingestion of supplement and test meal.
Pre-meal and changes in Desire to Eat
Time frame: 8.5 hours: fasting, before breakfast, at 30, 60, 120, 180 and 210 minutes following ingestion of supplement and a standard meal; at 30, 60, 120 and 180 minutes following ingestion of supplement and test meal.
Pre-meal and changes in Prospective Food Consumption
Time frame: 8.5 hours: fasting, before breakfast, at 30, 60, 120, 180 and 210 minutes following ingestion of supplement and a standard meal; at 30, 60, 120 and 180 minutes following ingestion of supplement and test meal.
Liking of test meals
Time frame: Mean of ratings taken immediately following the three test meals (single measure) - breakfast, lunch and dinner
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 27 Nov 2023.
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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.
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 Whey Protein Concentrate and Whey hydrolysate in people with Aging and Appetite Loss, run by University College Dublin at 1 site in Ireland.
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 4 inclusion and 9 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 27 Nov 2023. 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 Ireland. 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. Some participants in this study may receive a placebo. 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?
Pre-meal and changes in Composite Appetite Score (time frame: 8.5 hours: fasting, before breakfast, at 30, 60, 120, 180 and 210 minutes after ingestion of supplement and a standard meal; at 30, 60, 120 and 180 minutes following ingestion of supplement and lunch test meal. And immediately after each test meal.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Nov 2023.