HealthyNCT05840627
Acute Satiety and Metabolic Response of Daily Consumption of a Fruit Juice
A study testing Fruit juice in people with Healthy, run by Universidade Nova de Lisboa at 1 site in Portugal.
Trial summary
The "cLabel+ Innovative natural, nutritious and consumer-oriented clean label food" is a research and technological development project centered on responding to the challenges facing the food industry. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Fruit juice
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 sitePortugal
- Study dates
- 28 Feb 2023to 6 Apr 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Men or women
- Adults (age ≥ 18 years)
- Filling informed consent
Who cannot join
- Obesity (body mass index ≥ 30.0 kg/m2).
- Daily consumption of fruit juices in the month prior to the start of the study.
- Individuals with diagnosed food allergies or intolerances to the components being tested.
- Use of pro/prebiotics or fibre as a dietary supplement or any food/molecule that modifies intestinal transit time 6 weeks before recruitment.
- Use of laxatives 6 weeks before recruitment.
- Recent weight loss or weight gain of more than 10% in the last 3 months.
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- Adherence to restrictive weight loss diets or specific dietary pattern (e.g., palaeolithic diet, Atkins, flexitarian, ketogenic, vegan).
- Diagnosis of gastrointestinal pathology, hormonal or thyroid pathology, autoimmune diseases, chronic use of corticosteroids, psychiatric disease, or diabetes mellitus.
- Having taken antibiotics within the 12 weeks prior to beginning the study.
- Excessive consumption of alcoholic beverages (>14 and >8 units/week for men and women, respectively).
- Pregnant or breastfeeding.
- Participation in another clinical trial within the past 3 months that the Principal Investigator believes may compromise the results of the trial (e.g., clinical trial with an effect on the composition and diversity of the gut microbiota).
Trial locations and contacts
1 site in 1 country.
Portugal1 site
NOVA Medical School|Faculdade de Ciências Médicas, Universidade NOVA de Lisboa
Lisbon
About this study
Official title: The Effect of Daily Consumption of a Fruit Juice on Acute Satiety Response and Gut Microbiota Changes in Healthy Adults
The "cLabel+ Innovative natural, nutritious and consumer-oriented clean label food" is a research and technological development project centered on responding to the challenges facing the food industry. It is focused on the concept of "clean label", which emerges as one of the major current trends in the sector, given the growing number of consumers who are increasingly aware and eager for information, who are looking for alternative, more transparent and natural food products.
Thus, one of the aims of the cLabel+ project is to research the macronutrients and phenolic compounds present in food matrices and achieve a clean label positioning for the final products developed. This single group assignment clinical trial aims to evaluate the effect of daily consumption of a fruit juice, developed as part of the collaborative project cLabel+, on gut microbiota composition and diversity in healthy adults. It is also intended to study the acute metabolic effect, namely in terms of appetite control, and lipid and glucose metabolism.
- Conditions
- Healthy
- Being tested
- Fruit juice
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fruit juiceOther
Daily consumption of 200 mL of fruit juice at lunch for 14 consecutive days, provided by the research team.
| Study group | Role | What they receive |
|---|---|---|
| Fruit juice | Experimental | Not described Receives: Other: Fruit juice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in gut microbiota characterization
Differences in gut microbiota taxonomic characterization from baseline to the end of the intervention.
Measured: 14 days
Changes in gut microbiota diversity
Difference in gut microbiota Shannon index, from baseline to the end of intervention.
Measured: 14 days
Changes in the iAUC (pmol/L*min) for ghrelin
Ghrelin will be measured in fasting and every 30 minutes up to 3 hours. The iAUC (pmol/L*min) for ghrelin will be calculated based on the concentration curve following consumption of the fruit juice.
Measured: 14 days
Changes in the iAUC (pmol/L*min) for glucagon-like peptide-1 (GLP-1)
GLP-1 will be measured in fasting and every 30 minutes up to 3 hours. The iAUC (pmol/L*min) for GLP-1 will be calculated based on the concentration curve following consumption of the fruit juice.
Measured: 14 days
Changes in the iAUC (pmol/L*min) for peptide YY (PYY)
PYY will be measured in fasting and every 30 minutes up to 3 hours. The iAUC (pmol/L*min) for PYY will be calculated based on the concentration curve following consumption of the fruit juice.
Measured: 14 days
Secondary outcomes (15)
Changes in fasting glucose
Changes in fasting glucose, measured in mg/dL, from baseline to the end of intervention.
Measured: 14 days
Changes in fasting insulin
Changes in fasting insulin, measured in mg/dL, from baseline to the end of intervention.
Measured: 14 days
Changes in HOMA-IR
Changes in HOMA-IR from baseline to the end of intervention.
Measured: 14 days
Changes in total cholesterol
Changes in total cholesterol, measured in mg/dL, from baseline to the end of intervention.
Measured: 14 days
Changes in LDL cholesterol
Changes in LDL cholesterol, measured in mg/dL, from baseline to the end of intervention.
Measured: 14 days
Changes in HDL cholesterol
Changes in HDL cholesterol, measured in mg/dL, from baseline to the end of intervention.
Measured: 14 days
Changes in triacylglycerols
Changes in triacylglycerols, measured in mg/dL, from baseline to the end of intervention.
Measured: 14 days
Changes in high sensitivity PCR
Changes in high sensitivity PCR, measured in mg/dL, from baseline to the end of intervention.
Measured: 14 days
Changes in expired breath H2
Changes in expired breath H2, measured in ppm, from baseline to the end of intervention.
Measured: 14 days
Changes in expired breath CH4
Changes in expired breath CH4, measured in ppm, from baseline to the end of intervention.
Measured: 14 days
Changes in faecal butyrate
Changes in faecal butyrate, measured in M, from baseline to the end of intervention.
Measured: 14 days
Changes in faecal acetate
Changes in faecal acetate, measured in M, from baseline to the end of intervention.
Measured: 14 days
Changes in faecal alkaline phosphatase (ALP)
Changes in faecal ALP, measured in mg/g faeces, from baseline to the end of intervention.
Measured: 14 days
Changes in faecal LPS
Changes in faecal LPS, measured in EU/mL, from baseline to the end of intervention.
Measured: 14 days
Changes in faecal calprotectin
Changes in faecal calprotectin, measured in µg/g faeces, from baseline to the end of intervention.
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2023
- Study start28 Feb 2023
- Primary completion6 Apr 2023
- Study completion6 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Nova de Lisboa
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05840627
- Sponsor's protocol ID
- cLabel+
- Status last verified
- Apr 2023
- First submitted
- 6 Mar 2023
- Last updated
- 3 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Daily Consumption of a Fruit Juice on Acute Satiety Response and Gut Microbiota Changes in Healthy Adults
- ClinicalTrials.gov ID
- NCT05840627
- Acronym / sponsor ID
- cLabel+
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Universidade Nova de LisboaUniversity, hospital or other
- Study start
- 28 Feb 2023 (actual)
- Primary completion
- 6 Apr 2023 (actual)
- Study completion
- 6 Apr 2023 (actual)
- First posted
- 3 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.
The "cLabel+ Innovative natural, nutritious and consumer-oriented clean label food" is a research and technological development project centered on responding to the challenges facing the food industry. It is focused on the concept of "clean label", which emerges as one of the major current trends in the sector, given the growing number of consumers who are increasingly aware and eager for information, who are looking for alternative, more transparent and natural food products.
Thus, one of the aims of the cLabel+ project is to research the macronutrients and phenolic compounds present in food matrices and achieve a clean label positioning for the final products developed. This single group assignment clinical trial aims to evaluate the effect of daily consumption of a fruit juice, developed as part of the collaborative project cLabel+, on gut microbiota composition and diversity in healthy adults. It is also intended to study the acute metabolic effect, namely in terms of appetite control, and lipid and glucose metabolism.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fruit juice | Experimental | Other: Fruit juice |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Men or women
- Adults (age ≥ 18 years)
- Filling informed consent
Key exclusion criteria (12 listed)
- Obesity (body mass index ≥ 30.0 kg/m2).
- Daily consumption of fruit juices in the month prior to the start of the study.
- Individuals with diagnosed food allergies or intolerances to the components being tested.
- Use of pro/prebiotics or fibre as a dietary supplement or any food/molecule that modifies intestinal transit time 6 weeks before recruitment.
- Use of laxatives 6 weeks before recruitment.
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 |
|---|---|---|
| Fruit juiceDaily consumption of 200 mL of fruit juice at lunch for 14 consecutive days, provided by the research team. | Other | Fruit juice |
Primary outcome
Changes in gut microbiota characterization
Time frame: 14 days
Differences in gut microbiota taxonomic characterization from baseline to the end of the intervention.
Changes in gut microbiota diversity
Time frame: 14 days
Difference in gut microbiota Shannon index, from baseline to the end of intervention.
Changes in the iAUC (pmol/L*min) for ghrelin
Time frame: 14 days
Ghrelin will be measured in fasting and every 30 minutes up to 3 hours. The iAUC (pmol/L*min) for ghrelin will be calculated based on the concentration curve following consumption of the fruit juice.
Changes in the iAUC (pmol/L*min) for glucagon-like peptide-1 (GLP-1)
Time frame: 14 days
GLP-1 will be measured in fasting and every 30 minutes up to 3 hours. The iAUC (pmol/L*min) for GLP-1 will be calculated based on the concentration curve following consumption of the fruit juice.
Changes in the iAUC (pmol/L*min) for peptide YY (PYY)
Time frame: 14 days
PYY will be measured in fasting and every 30 minutes up to 3 hours. The iAUC (pmol/L*min) for PYY will be calculated based on the concentration curve following consumption of the fruit juice.
15 secondary outcomes
Changes in fasting glucose
Time frame: 14 days
Changes in fasting insulin
Time frame: 14 days
Changes in HOMA-IR
Time frame: 14 days
Changes in total cholesterol
Time frame: 14 days
Changes in LDL cholesterol
Time frame: 14 days
Changes in HDL cholesterol
Time frame: 14 days
Changes in triacylglycerols
Time frame: 14 days
Changes in high sensitivity PCR
Time frame: 14 days
Changes in expired breath H2
Time frame: 14 days
Changes in expired breath CH4
Time frame: 14 days
Changes in faecal butyrate
Time frame: 14 days
Changes in faecal acetate
Time frame: 14 days
Changes in faecal alkaline phosphatase (ALP)
Time frame: 14 days
Changes in faecal LPS
Time frame: 14 days
Changes in faecal calprotectin
Time frame: 14 days
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 3 May 2023.
- 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.
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 Fruit juice in people with Healthy, run by Universidade Nova de Lisboa at 1 site in Portugal.
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 3 inclusion and 12 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 3 May 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 Portugal. 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?
Changes in gut microbiota characterization (time frame: 14 days). The study lists 5 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 3 May 2023.