LipemiaNCT05539742
Comparison of the Effect of MCFA and LCFA on Postprandial Appetite and Lipemia
A study testing Coconut oil and Palm oil in people with Lipemia, run by University of Jordan at 2 sites in Jordan.
Trial summary
The main objective is to investigate if foods high in coconut oil (MCFA) or palm oil (LCFA) have different impacts on postprandial blood lipid levels and appetite via a visual analog scale (VAS). Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Lipemia
- What is being tested?
- Coconut oil and Palm oil
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 2 sitesJordan
- Study dates
- 1 Jun 2022to 1 Nov 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 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age between 18-50 years
- Males and females
- Apparently healthy
- Fasting triglyceride (TG) < 2.5 mmol/L or 222 mg/dl at the time of screening.
- Body mass index (BMI) in normal range (18.5-24.9).
- Stable weight for at least 3 months
Who cannot join
- Consumption of lipid-lowering drugs or any medication that might affect appetite.
- Consumption of any supplement that may affect lipid metabolism or appetite on a regular basis for the past month.
- Regular consumption of two or more fish meals a week over the previous month.
- A history of diabetes, gastrointestinal , liver disease, congestive heart failure, stroke, myocardial infarction, coronary artery bypass graft or established atherosclerotic disease.
- Current smokers
- Pregnant , breastfeeding, postmenopausal or suffer from polycystic ovary syndrome (PCOS)
- Athlete
- Being on a diet or lifestyle changes for the past month.
Trial locations and contacts
2 sites in 1 country.
Jordan2 sites
The University of Jordan
Amman, 11942
The University of Jordan
Amman
About this study
Official title: Comparison of the Effect of Medium-Chain Fatty Acids and Long-Chain Fatty Acids on Postprandial Appetite and Lipemia
The main objective is to investigate if foods high in coconut oil (MCFA) or palm oil (LCFA) have different impacts on postprandial blood lipid levels and appetite via a visual analog scale (VAS).
Read the detailed description
Postprandial lipemia has been recognized as a cardiovascular disease risk factor. The rate of postprandial triglyceride production and clearance in the blood, as well as the appetite, are influenced by the quality of the food consumed, such as the length of saturated fatty acids. The study will include 24 healthy adults ranging in age from 18 to 40 years old, of both sexes and it will be conducted at the University of Jordan. The study will involve two experimental test days, each separated by at least a week of washout interval, and each test day will last for 6 hours. All subjects will be randomly assigned to one of the experimental meals using computer-generated tables. Blood serum samples (2 mL) will be taken after an overnight fast and 2, 4, and 6 hours after eating the meals, and blood lipid profiles [total cholesterol (TC), low-density lipoprotein cholesterol (LDL-C), high-density lipoprotein cholesterol (HDL-C), and triglyceride (TG)] will be examined in a private lab. After that, participants will be allowed an ad libitum intake of standard meals. Each meal will be weighed before and after it is consumed, with the amount of food ingested being calculated.
- Conditions
- Lipemia
- Being tested
- Coconut oil, Palm oil
- Keywords
- Postprandial lipemia
- Medical subject headings
- Hyperlipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coconut oilDietary supplement
Coconut oil will be given to each participant in the amount of 40 g, which will be incorporated into biscuits.
Palm oilDietary supplement
Palm oil will be given to each participant in the amount of 40 g, which will be incorporated into biscuits.
| Study group | Role | What they receive |
|---|---|---|
| Coconut oil | Active comparator | The coconut oil will be given to each participant in the amount of 40 g, which will be incorporated into biscuits. Each participant will have ten minutes to consume biscuits with 250 ml of water. No other food will be consumed during the study period (6 hours). After that, participants will be allowed an ad libitum intake of standard meals. Each meal will be weighed before and after it is consumed, with the amount of food ingested being calculated. Then the participants will take the other treatment after a 1-week washout interval. Receives: Dietary Supplement: Coconut oil |
| Palm oil | Active comparator | The palm oil will be given to each participant in the amount of 40 g, which will be incorporated into biscuits. Each participant will have ten minutes to consume biscuits with 250 ml of water. No other food will be consumed during the study period (6 hours). After that, participants will be allowed an ad libitum intake of standard meals. Each meal will be weighed before and after it is consumed, with the amount of food ingested being calculated. Then the participants will take the other treatment after a 1-week washout interval. Receives: Dietary Supplement: Palm oil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anthropometric measurements ( Height)
Standing height, without footwear, will be taken using stadiometer to the nearest 5mm
Measured: baseline, pre-intervention, 1 day for each participant /during 3 months
Anthropometric measurements (Weight)
Bioelectrical impedance will be used to determine body weight
Measured: baseline, pre-intervention, 1 day for each participant /during 3 months
Anthropometric measurements (waist circumference)
Waist circumference (WC) will be measured at the midway between the lowest ribs and the iliac crest using a standard tape to the nearest 1 cm
Measured: baseline, pre-intervention, 1 day for each participant /during 3 months
Anthropometric measurements (percentage body fat)
Bioelectrical impedance will be used to determine body composition
Measured: baseline, pre-intervention,1 day for each participant /during 3 months
Biochemical measurements (Total cholesterol (TC))
Up to 6 hours
Measured: After the intervention / up to 3 months from collecting the samples
Biochemical measurements (Low density lipoprotein cholesterol (LDL))
Low-density lipoprotein cholesterol test will be performed after an overnight fast and 2, 4, and 6 hours after eating the meals
Measured: Up to 6 hours
Biochemical measurements ( High density lipoprotein cholesterol (HDL))
High-density lipoprotein cholesterol test will be performed after an overnight fast and 2, 4, and 6 hours after eating the meals
Measured: Up to 6 hours
Biochemical measurements (Triglyceride (TG))
Triglyceride test will be performed after an overnight fast and 2, 4, and 6 hours after eating the meals
Measured: Up to 6 hours
Dietary intake (3-days food record)
Participants will be asked to fill out a food record to track changes in their (intake) appetite
Measured: one day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2022
- Study start1 Jun 2022
- Primary completion1 Oct 2022
- Study completion1 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (23)Papers the sponsor has linked to this study.
- Other trials for LipemiaStudies 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
- randomized crossover single-blinded intervention study
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Jordan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shatha Hammad, Assistant Professor, University of Jordan
- Investigators
- Shatha S Hammad, PhD, Principal investigator, University of Jordan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05539742
- Sponsor's protocol ID
- 2022/6
- Status last verified
- Aug 2023
- First submitted
- 13 Jun 2022
- Last updated
- 29 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Austin G, Ferguson JJ, Thota RN, Singh H, Burrows T, Garg ML. Postprandial lipaemia following consumption of a meal enriched with medium chain saturated and/or long chain omega-3 polyunsaturated fatty acids. A randomised cross-over study. Clin Nutr. 2021 Feb;40(2):420-427. doi: 10.1016/j.clnu.2020.06.027. Epub 2020 Jul 1.
PubMed 32684486Abedi E, Sahari MA. Long-chain polyunsaturated fatty acid sources and evaluation of their nutritional and functional properties. Food Sci Nutr. 2014 Sep;2(5):443-63. doi: 10.1002/fsn3.121. Epub 2014 Jun 29.
PubMed 25473503Behrouz V, Yari Z. A review on differential effects of dietary fatty acids on weight, appetite and energy expenditure. Crit Rev Food Sci Nutr. 2022;62(8):2235-2249. doi: 10.1080/10408398.2020.1852172. Epub 2020 Dec 1.
PubMed 33261509Boateng L, Ansong R, Owusu WB, Steiner-Asiedu M. Coconut oil and palm oil's role in nutrition, health and national development: A review. Ghana Med J. 2016 Sep;50(3):189-196.
PubMed 27752194Bozzetto L, Della Pepa G, Vetrani C, Rivellese AA. Dietary Impact on Postprandial Lipemia. Front Endocrinol (Lausanne). 2020 Jul 7;11:337. doi: 10.3389/fendo.2020.00337. eCollection 2020.
PubMed 32733374Dias CB, Moughan PJ, Wood LG, Singh H, Garg ML. Postprandial lipemia: factoring in lipemic response for ranking foods for their healthiness. Lipids Health Dis. 2017 Sep 18;16(1):178. doi: 10.1186/s12944-017-0568-5.
PubMed 28923057Folwaczny A, Waldmann E, Altenhofer J, Henze K, Parhofer KG. Postprandial Lipid Metabolism in Normolipidemic Subjects and Patients with Mild to Moderate Hypertriglyceridemia: Effects of Test Meals Containing Saturated Fatty Acids, Mono-Unsaturated Fatty Acids, or Medium-Chain Fatty Acids. Nutrients. 2021 May 20;13(5):1737. doi: 10.3390/nu13051737.
PubMed 34065380Karupaiah T, Tan CH, Chinna K, Sundram K. The chain length of dietary saturated fatty acids affects human postprandial lipemia. J Am Coll Nutr. 2011 Dec;30(6):511-21. doi: 10.1080/07315724.2011.10719997.
PubMed 22331686Kaviani S, Cooper JA. Appetite responses to high-fat meals or diets of varying fatty acid composition: a comprehensive review. Eur J Clin Nutr. 2017 Oct;71(10):1154-1165. doi: 10.1038/ejcn.2016.250. Epub 2017 Jan 18.
PubMed 28098139Khaw KT, Sharp SJ, Finikarides L, Afzal I, Lentjes M, Luben R, Forouhi NG. Randomised trial of coconut oil, olive oil or butter on blood lipids and other cardiovascular risk factors in healthy men and women. BMJ Open. 2018 Mar 6;8(3):e020167. doi: 10.1136/bmjopen-2017-020167.
PubMed 29511019Maher T, Sampson A, Goslawska M, Pangua-Irigaray C, Shafat A, Clegg ME. Food Intake and Satiety Response after Medium-Chain Triglycerides Ingested as Solid or Liquid. Nutrients. 2019 Jul 17;11(7):1638. doi: 10.3390/nu11071638.
PubMed 31319633Ma WY, Yang CY, Shih SR, Hsieh HJ, Hung CS, Chiu FC, Lin MS, Liu PH, Hua CH, Hsein YC, Chuang LM, Lin JW, Wei JN, Li HY. Measurement of Waist Circumference: midabdominal or iliac crest? Diabetes Care. 2013 Jun;36(6):1660-6. doi: 10.2337/dc12-1452. Epub 2012 Dec 28.
PubMed 23275359Moneeb AHM, Hammam ARA, Ahmed AKA, Ahmed ME, Alsaleem KA. Effect of fat extraction methods on the fatty acids composition of bovine milk using gas chromatography. Food Sci Nutr. 2021 May 4;9(6):2936-2942. doi: 10.1002/fsn3.2252. eCollection 2021 Jun.
PubMed 34136161Montoya C, Cochard B, Flori A, Cros D, Lopes R, Cuellar T, Espeout S, Syaputra I, Villeneuve P, Pina M, Ritter E, Leroy T, Billotte N. Genetic architecture of palm oil fatty acid composition in cultivated oil palm (Elaeis guineensis Jacq.) compared to its wild relative E. oleifera (H.B.K) Cortes. PLoS One. 2014 May 9;9(5):e95412. doi: 10.1371/journal.pone.0095412. eCollection 2014.
PubMed 24816555Panth N, Abbott KA, Dias CB, Wynne K, Garg ML. Differential effects of medium- and long-chain saturated fatty acids on blood lipid profile: a systematic review and meta-analysis. Am J Clin Nutr. 2018 Oct 1;108(4):675-687. doi: 10.1093/ajcn/nqy167.
PubMed 30239550
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effect of Medium-Chain Fatty Acids and Long-Chain Fatty Acids on Postprandial Appetite and Lipemia
- ClinicalTrials.gov ID
- NCT05539742
- Acronym / sponsor ID
- 2022/6
- Conditions
- Lipemia
- Keywords
- Postprandial lipemia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- University of JordanUniversity, hospital or other
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 1 Oct 2022 (actual)
- Study completion
- 1 Nov 2022 (actual)
- First posted
- 14 Sep 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.
The main objective is to investigate if foods high in coconut oil (MCFA) or palm oil (LCFA) have different impacts on postprandial blood lipid levels and appetite via a visual analog scale (VAS).
Detailed description
Postprandial lipemia has been recognized as a cardiovascular disease risk factor. The rate of postprandial triglyceride production and clearance in the blood, as well as the appetite, are influenced by the quality of the food consumed, such as the length of saturated fatty acids. The study will include 24 healthy adults ranging in age from 18 to 40 years old, of both sexes and it will be conducted at the University of Jordan. The study will involve two experimental test days, each separated by at least a week of washout interval, and each test day will last for 6 hours. All subjects will be randomly assigned to one of the experimental meals using computer-generated tables. Blood serum samples (2 mL) will be taken after an overnight fast and 2, 4, and 6 hours after eating the meals, and blood lipid profiles [total cholesterol (TC), low-density lipoprotein cholesterol (LDL-C), high-density lipoprotein cholesterol (HDL-C), and triglyceride (TG)] will be examined in a private lab. After that, participants will be allowed an ad libitum intake of standard meals. Each meal will be weighed before and after it is consumed, with the amount of food ingested being calculated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- randomized crossover single-blinded intervention study
| Arm | Type | Receives |
|---|---|---|
| Coconut oil | Active comparator | Dietary Supplement: Coconut oilThe coconut oil will be given to each participant in the amount of 40 g, which will be incorporated into biscuits. Each participant will have ten minutes to consume biscuits with 250 ml of water. No other food will be consumed during the study period (6 hours). After that, participants will be allowed an ad libitum intake of standard meals. Each meal will be weighed before and after it is consumed, with the amount of food ingested being calculated. Then the participants will take the other treatment after a 1-week washout interval. |
| Palm oil | Active comparator | Dietary Supplement: Palm oilThe palm oil will be given to each participant in the amount of 40 g, which will be incorporated into biscuits. Each participant will have ten minutes to consume biscuits with 250 ml of water. No other food will be consumed during the study period (6 hours). After that, participants will be allowed an ad libitum intake of standard meals. Each meal will be weighed before and after it is consumed, with the amount of food ingested being calculated. Then the participants will take the other treatment after a 1-week washout interval. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Age between 18-50 years
- Males and females
- Apparently healthy
- Fasting triglyceride (TG) < 2.5 mmol/L or 222 mg/dl at the time of screening.
- Body mass index (BMI) in normal range (18.5-24.9).
Key exclusion criteria (8 listed)
- Consumption of lipid-lowering drugs or any medication that might affect appetite.
- Consumption of any supplement that may affect lipid metabolism or appetite on a regular basis for the past month.
- Regular consumption of two or more fish meals a week over the previous month.
- A history of diabetes, gastrointestinal , liver disease, congestive heart failure, stroke, myocardial infarction, coronary artery bypass graft or established atherosclerotic disease.
- Current smokers
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 |
|---|---|---|
| Coconut oilCoconut oil will be given to each participant in the amount of 40 g, which will be incorporated into biscuits. | Dietary supplement | Coconut oil |
| Palm oilPalm oil will be given to each participant in the amount of 40 g, which will be incorporated into biscuits. | Dietary supplement | Palm oil |
Primary outcome
Anthropometric measurements ( Height)
Time frame: baseline, pre-intervention, 1 day for each participant /during 3 months
Standing height, without footwear, will be taken using stadiometer to the nearest 5mm
Anthropometric measurements (Weight)
Time frame: baseline, pre-intervention, 1 day for each participant /during 3 months
Bioelectrical impedance will be used to determine body weight
Anthropometric measurements (waist circumference)
Time frame: baseline, pre-intervention, 1 day for each participant /during 3 months
Waist circumference (WC) will be measured at the midway between the lowest ribs and the iliac crest using a standard tape to the nearest 1 cm
Anthropometric measurements (percentage body fat)
Time frame: baseline, pre-intervention,1 day for each participant /during 3 months
Bioelectrical impedance will be used to determine body composition
Biochemical measurements (Total cholesterol (TC))
Time frame: After the intervention / up to 3 months from collecting the samples
Up to 6 hours
Biochemical measurements (Low density lipoprotein cholesterol (LDL))
Time frame: Up to 6 hours
Low-density lipoprotein cholesterol test will be performed after an overnight fast and 2, 4, and 6 hours after eating the meals
Biochemical measurements ( High density lipoprotein cholesterol (HDL))
Time frame: Up to 6 hours
High-density lipoprotein cholesterol test will be performed after an overnight fast and 2, 4, and 6 hours after eating the meals
Biochemical measurements (Triglyceride (TG))
Time frame: Up to 6 hours
Triglyceride test will be performed after an overnight fast and 2, 4, and 6 hours after eating the meals
Dietary intake (3-days food record)
Time frame: one day
Participants will be asked to fill out a food record to track changes in their (intake) appetite
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 29 Aug 2023.
- Background: PubMed 32684486Austin G, Ferguson JJ, Thota RN, Singh H, Burrows T, Garg ML. Postprandial lipaemia following consumption of a meal enriched with medium chain saturated and/or long chain omega-3 polyunsaturated fatty acids. A randomised cross-over study. Clin Nutr. 2021 Feb;40(2):420-427. doi: 10.1016/j.clnu.2020.06.027. Epub 2020 Jul 1.
- Background: PubMed 25473503Abedi E, Sahari MA. Long-chain polyunsaturated fatty acid sources and evaluation of their nutritional and functional properties. Food Sci Nutr. 2014 Sep;2(5):443-63. doi: 10.1002/fsn3.121. Epub 2014 Jun 29.
- Background: PubMed 33261509Behrouz V, Yari Z. A review on differential effects of dietary fatty acids on weight, appetite and energy expenditure. Crit Rev Food Sci Nutr. 2022;62(8):2235-2249. doi: 10.1080/10408398.2020.1852172. Epub 2020 Dec 1.
- Background: PubMed 27752194Boateng L, Ansong R, Owusu WB, Steiner-Asiedu M. Coconut oil and palm oil's role in nutrition, health and national development: A review. Ghana Med J. 2016 Sep;50(3):189-196.
- Background: PubMed 32733374Bozzetto L, Della Pepa G, Vetrani C, Rivellese AA. Dietary Impact on Postprandial Lipemia. Front Endocrinol (Lausanne). 2020 Jul 7;11:337. doi: 10.3389/fendo.2020.00337. eCollection 2020.
- Background: PubMed 28923057Dias CB, Moughan PJ, Wood LG, Singh H, Garg ML. Postprandial lipemia: factoring in lipemic response for ranking foods for their healthiness. Lipids Health Dis. 2017 Sep 18;16(1):178. doi: 10.1186/s12944-017-0568-5.
- Background: PubMed 34065380Folwaczny A, Waldmann E, Altenhofer J, Henze K, Parhofer KG. Postprandial Lipid Metabolism in Normolipidemic Subjects and Patients with Mild to Moderate Hypertriglyceridemia: Effects of Test Meals Containing Saturated Fatty Acids, Mono-Unsaturated Fatty Acids, or Medium-Chain Fatty Acids. Nutrients. 2021 May 20;13(5):1737. doi: 10.3390/nu13051737.
- Background: PubMed 22331686Karupaiah T, Tan CH, Chinna K, Sundram K. The chain length of dietary saturated fatty acids affects human postprandial lipemia. J Am Coll Nutr. 2011 Dec;30(6):511-21. doi: 10.1080/07315724.2011.10719997.
- Background: PubMed 28098139Kaviani S, Cooper JA. Appetite responses to high-fat meals or diets of varying fatty acid composition: a comprehensive review. Eur J Clin Nutr. 2017 Oct;71(10):1154-1165. doi: 10.1038/ejcn.2016.250. Epub 2017 Jan 18.
- Background: PubMed 29511019Khaw KT, Sharp SJ, Finikarides L, Afzal I, Lentjes M, Luben R, Forouhi NG. Randomised trial of coconut oil, olive oil or butter on blood lipids and other cardiovascular risk factors in healthy men and women. BMJ Open. 2018 Mar 6;8(3):e020167. doi: 10.1136/bmjopen-2017-020167.
- Background: PubMed 31319633Maher T, Sampson A, Goslawska M, Pangua-Irigaray C, Shafat A, Clegg ME. Food Intake and Satiety Response after Medium-Chain Triglycerides Ingested as Solid or Liquid. Nutrients. 2019 Jul 17;11(7):1638. doi: 10.3390/nu11071638.
- Background: PubMed 23275359Ma WY, Yang CY, Shih SR, Hsieh HJ, Hung CS, Chiu FC, Lin MS, Liu PH, Hua CH, Hsein YC, Chuang LM, Lin JW, Wei JN, Li HY. Measurement of Waist Circumference: midabdominal or iliac crest? Diabetes Care. 2013 Jun;36(6):1660-6. doi: 10.2337/dc12-1452. Epub 2012 Dec 28.
- Individual participant dataSharing planned: No
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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.
Shatha S Hammad, PhD principal investigator
University of Jordan
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Coconut oil and Palm oil in people with Lipemia, run by University of Jordan at 2 sites in Jordan.
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 6 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 29 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Jordan. 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?
Anthropometric measurements ( Height) (time frame: baseline, pre-intervention, 1 day for each participant /during 3 months). The study lists 9 primary outcomes in all. 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 NCT05539742, which also lists 23 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 29 Aug 2023.