KetosisNCT05656339
Metabolic Effects of Whey Protein Supplementation After Fasting in Volunteers
A study testing CHO+WP, CHO and Fast in people with Ketosis and Acute-Phase Response, run by Federal University of Mato Grosso at 1 site in Brazil.
Trial summary
This study aims to investigate the early metabolic effects and acute phase response of an oral clear supplement containing whey protein plus carbohydrates in young healthy volunteers during fasting-induced organic response Read more about this study
- Who is it for?
- Ages 18 to 30 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Ketosis, Acute-Phase Response, Insulin Resistance
- What is being tested?
- CHO+WP, CHO and Fast
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Nov 2022to 30 Jan 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 18 to 30 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male young healthy volunteers
Who cannot join
- Individuals with obesity (calculated body mass index above 30 kg/m2)
- Participants reporting consumption of alcoholic beverages
- Consumption of any nutritional supplement during the study period
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Centro Universitário de Varzea Grande (UNIVAG)
Várzea Grande, Mato Grosso, 78.118-000
Thais C Dombroski, PhD, +55 653688-6111, cep@univag.edu.br
About this study
Official title: Metabolic Effects of Whey Protein Supplementation After Fasting in Volunteers: A Controlled Randomized Crossover Trial
This study aims to investigate the early metabolic effects and acute phase response of an oral clear supplement containing whey protein plus carbohydrates in young healthy volunteers during fasting-induced organic response
Read the detailed description
The investigators will enroll young male healthy volunteers. In this controlled crossover clinical trial, after a 12-hour fast, subjects will be randomized to consumed either: a) 200ml of carbohydrates enriched with whey protein (CHO+WP; n=30); or b) 200ml of water plus maltodextrin (CHO group, n=30); or c) remained fasting (Fast group; n=30). Blood samples will be collected after 12h-fast and three hours after the ingestion of the supplements (or 3h fast in Fast group) for blood glucose; glycated hemoglobin; serum insulin; C-reactive protein; beta-hydroxybutyrate; triglycerides; albumin; chlorine and sodium assays. After a temporal break of seven days an inversion of the groups will performed so all subjects entered in the three groups. Group CHO+P will drink a clear non-residual supplement (698 mOsm/L) having 100% whey protein isolated from total proteins, with various vitamins (B1, B6, C, D, niacin and folic acid) with a "lemon tea" flavor (Nutren Fresh; Nestlé, São Paulo, Brazil). The formula contains no lactose or lipids; is formulated with a volume of 200ml, with a caloric density of 1.28kcal/ml; protein: 10g in 200ml of the product (100% whey protein isolate); and carbohydrate: 54g in 200ml of the product (74% glucose syrup and 26% maltodextrin); Group CHO will received a clear supplement containing 200 mL of water combined with unflavored 25 g of 100% maltodextrin (CarboCH - Prodiet, Curitiba, Brazil) at 12.5% dilution (101 mOsm/kg; 95kcal/200ml). The third group (Fast group; n=10) will not consume any food or supplement.
- Conditions
- Ketosis, Acute-Phase Response, Insulin Resistance
- Being tested
- CHO+WP, CHO, Fast
- Keywords
- Ketone bodies, Whey protein, Fasting
- Medical subject headings
- Ketosis, Acute-Phase Reaction, Insulin Resistance, Fasting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CHO+WPDietary supplement
Oral supplement containing carbohydrates plus whey protein
CHODietary supplement
Oral supplement containing carbohydrates
FastDietary supplement
Fast condition of 12 hours
| Study group | Role | What they receive |
|---|---|---|
| 12 hours Fast - Fast Group | Sham comparator | Participants will proceed in 12 hours fast condition for blood collection for laboratory assays Receives: Dietary Supplement: Fast |
| Carbohydrate plus whey protein supplement - CHO+WP group | Active comparator | After 12 hours fast participants will collect blood samples and immediately will drink an oral supplement containing carbohydrates plus whey protein. After 3 hours of ingesting the supplement blood samples will be collected again Receives: Dietary Supplement: CHO+WP |
| Carbohydrate supplement - CHO group | Placebo comparator | After 12 hours fast participants will collect blood samples and immediately will drink an oral supplement containing carbohydrates alone without whey protein. After 3 hours of ingesting the supplement blood samples will be collected again Receives: Dietary Supplement: CHO |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in serum hydroxy butyrate
Serum hydroxy butyrate levels from 12 hours fast at 3 hours after ingestion of oral supplement
Measured: Change from 12 hours fasting (baseline) at 3 hours after the ingestion of the oral supplement
Change in acute phase response proteins
Change of serum C reactive protein and albumin from 12 hours fast (baseline) to 3 hours after ingestion of the oral supplement
Measured: Change from12 hours fasting (baseline) at 3 hours after the ingestion of the oral supplement
Change in insulin resistance
Change of HOMA index from 12 hours fast (baseline) to 3 hours after ingestion of the oral supplement
Measured: Change from12 hours fasting (baseline) at 3 hours after the ingestion of the oral supplement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2022
- Study start1 Nov 2022
- Primary completion30 Dec 2022 (estimated)
- Study completion30 Jan 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for KetosisStudies 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
- Male volunteers, aged between 18 and 27 years, healthy, with no report of acute illness during 3 months prior to the study will be included. Individuals with obesity (calculated body mass index above 30 kg/m2), those who reported consumption of alcoholic beverages or any nutritional supplement during the study period will be excluded. The 30 selected volunteers will be scheduled to came to the laboratory after an overnight fast of 12 hours. Participants in the fasting group will immediately collect blood samples. The CHO and the CHO+WP groups will drink 200 ml of the respective supplements described above. After an interval of three hours after ingestion of the supplement, blood samples will be collected again for biochemical assays.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Federal University of Mato Grosso
- Sponsor type
- University, hospital or other
- Collaborators
- Univag Centro Universitário
- Responsible party
- Principal investigator, José Eduardo de Aguilar-Nascimento, MD, PhD, Federal University of Mato Grosso
- Investigators
- Jose E Nascimento, MD, PhD, Principal investigator, Univag Centro Universitário
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05656339
- Sponsor's protocol ID
- 42481121.3.0000.5692
- Status last verified
- Dec 2022
- First submitted
- 22 Nov 2022
- Last updated
- 19 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD will be shared with researchers that contact with the investigator
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metabolic Effects of Whey Protein Supplementation After Fasting in Volunteers: A Controlled Randomized Crossover Trial
- ClinicalTrials.gov ID
- NCT05656339
- Acronym / sponsor ID
- 42481121.3.0000.5692
- Conditions
- Ketosis, Acute-Phase Response, Insulin Resistance
- Keywords
- Ketone bodies, Whey protein, Fasting
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Federal University of Mato GrossoUniversity, hospital or other
- Collaborators
- Univag Centro Universitário
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- 30 Dec 2022 (estimated)
- Study completion
- 30 Jan 2023 (estimated)
- First posted
- 19 Dec 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 investigate the early metabolic effects and acute phase response of an oral clear supplement containing whey protein plus carbohydrates in young healthy volunteers during fasting-induced organic response
Detailed description
The investigators will enroll young male healthy volunteers. In this controlled crossover clinical trial, after a 12-hour fast, subjects will be randomized to consumed either: a) 200ml of carbohydrates enriched with whey protein (CHO+WP; n=30); or b) 200ml of water plus maltodextrin (CHO group, n=30); or c) remained fasting (Fast group; n=30). Blood samples will be collected after 12h-fast and three hours after the ingestion of the supplements (or 3h fast in Fast group) for blood glucose; glycated hemoglobin; serum insulin; C-reactive protein; beta-hydroxybutyrate; triglycerides; albumin; chlorine and sodium assays. After a temporal break of seven days an inversion of the groups will performed so all subjects entered in the three groups. Group CHO+P will drink a clear non-residual supplement (698 mOsm/L) having 100% whey protein isolated from total proteins, with various vitamins (B1, B6, C, D, niacin and folic acid) with a "lemon tea" flavor (Nutren Fresh; Nestlé, São Paulo, Brazil). The formula contains no lactose or lipids; is formulated with a volume of 200ml, with a caloric density of 1.28kcal/ml; protein: 10g in 200ml of the product (100% whey protein isolate); and carbohydrate: 54g in 200ml of the product (74% glucose syrup and 26% maltodextrin); Group CHO will received a clear supplement containing 200 mL of water combined with unflavored 25 g of 100% maltodextrin (CarboCH - Prodiet, Curitiba, Brazil) at 12.5% dilution (101 mOsm/kg; 95kcal/200ml). The third group (Fast group; n=10) will not consume any food or supplement.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- Male volunteers, aged between 18 and 27 years, healthy, with no report of acute illness during 3 months prior to the study will be included. Individuals with obesity (calculated body mass index above 30 kg/m2), those who reported consumption of alcoholic beverages or any nutritional supplement during the study period will be excluded. The 30 selected volunteers will be scheduled to came to the laboratory after an overnight fast of 12 hours. Participants in the fasting group will immediately collect blood samples. The CHO and the CHO+WP groups will drink 200 ml of the respective supplements described above. After an interval of three hours after ingestion of the supplement, blood samples will be collected again for biochemical assays.
| Arm | Type | Receives |
|---|---|---|
| 12 hours Fast - Fast Group | Sham comparator | Dietary Supplement: FastParticipants will proceed in 12 hours fast condition for blood collection for laboratory assays |
| Carbohydrate plus whey protein supplement - CHO+WP group | Active comparator | Dietary Supplement: CHO+WPAfter 12 hours fast participants will collect blood samples and immediately will drink an oral supplement containing carbohydrates plus whey protein. After 3 hours of ingesting the supplement blood samples will be collected again |
| Carbohydrate supplement - CHO group | Placebo comparator | Dietary Supplement: CHOAfter 12 hours fast participants will collect blood samples and immediately will drink an oral supplement containing carbohydrates alone without whey protein. After 3 hours of ingesting the supplement blood samples will be collected again |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Male young healthy volunteers
Key exclusion criteria (3 listed)
- Individuals with obesity (calculated body mass index above 30 kg/m2)
- Participants reporting consumption of alcoholic beverages
- Consumption of any nutritional supplement during the study period
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 |
|---|---|---|
| CHO+WPOral supplement containing carbohydrates plus whey protein | Dietary supplement | Carbohydrate plus whey protein supplement - CHO+WP group |
| CHOOral supplement containing carbohydrates | Dietary supplement | Carbohydrate supplement - CHO group |
| FastFast condition of 12 hours | Dietary supplement | 12 hours Fast - Fast Group |
Primary outcome
Change in serum hydroxy butyrate
Time frame: Change from 12 hours fasting (baseline) at 3 hours after the ingestion of the oral supplement
Serum hydroxy butyrate levels from 12 hours fast at 3 hours after ingestion of oral supplement
Change in acute phase response proteins
Time frame: Change from12 hours fasting (baseline) at 3 hours after the ingestion of the oral supplement
Change of serum C reactive protein and albumin from 12 hours fast (baseline) to 3 hours after ingestion of the oral supplement
Change in insulin resistance
Time frame: Change from12 hours fasting (baseline) at 3 hours after the ingestion of the oral supplement
Change of HOMA index from 12 hours fast (baseline) to 3 hours after ingestion of the oral supplement
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2022.
- Individual participant dataSharing planned: Yes. IPD will be shared with researchers that contact with the investigator
Related trials for Ketosis
RecruitingPhase 2/3
Effects of Ketone Supplementation on Alcohol Withdrawal and Brain Metabolism in Alcohol Use Disorder
Alcohol Use Disorder, Alcohol Withdrawal
Active, not recruiting
Effects of Short-term Adaptation to Ketogenic Diet on Endurance Trained Athletes
Ketogenic Diet, Control Condition
Recruiting
Variations in Ketone Metabolism
Ketosis
Not yet recruitingPhase 1/2
Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of PAL-119 in Healthy Volunteers and Adult Participants With Type 1 or Type 2 Diabetes
Healthy Volunteers and Diabetes Participants
Recruiting
LIfestyle MEtabotype Study B (LIME-B)
Nutritional and Metabolic Diseases, Prediabetes
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.
Jose E Nascimento, MD, PhD principal investigator
Univag Centro Universitário
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CHO+WP, CHO and Fast in people with Ketosis and Acute-Phase Response, run by Federal University of Mato Grosso at 1 site in Brazil.
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 1 inclusion and 3 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 19 Dec 2022. 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 Brazil. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jose Nascimento, MD, PhD (+5565999815388, jose.aguilar@univag.edu.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in serum hydroxy butyrate (time frame: Change from 12 hours fasting (baseline) at 3 hours after the ingestion of the oral supplement). The study lists 3 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 19 Dec 2022.