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Completed

NCT Number: NCT05840627

Acute Satiety and Metabolic Response of Daily Consumption of a Fruit Juice

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.

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Key information

Conditions

Healthy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

NOVA Medical School|Faculdade de Ciências Médicas, Universidade NOVA de Lisboa

Lisbon, Portugal

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Men or women
  • Adults (age ≥ 18 years)
  • Filling informed consent

Exclusion criteria

  • 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.
  • 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).

Treatment and study plan

Fruit juice

Other

Daily consumption of 200 mL of fruit juice at lunch for 14 consecutive days, provided by the research team.

Primary outcomes

  1. Changes in gut microbiota characterization

    Time frame: 14 days

    Differences in gut microbiota taxonomic characterization from baseline to the end of the intervention.

  2. Changes in gut microbiota diversity

    Time frame: 14 days

    Difference in gut microbiota Shannon index, from baseline to the end of intervention.

  3. 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.

  4. 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.

  5. 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.

Secondary outcomes

  1. Changes in fasting glucose

    Time frame: 14 days

    Changes in fasting glucose, measured in mg/dL, from baseline to the end of intervention.

  2. Changes in fasting insulin

    Time frame: 14 days

    Changes in fasting insulin, measured in mg/dL, from baseline to the end of intervention.

  3. Changes in HOMA-IR

    Time frame: 14 days

    Changes in HOMA-IR from baseline to the end of intervention.

  4. Changes in total cholesterol

    Time frame: 14 days

    Changes in total cholesterol, measured in mg/dL, from baseline to the end of intervention.

  5. Changes in LDL cholesterol

    Time frame: 14 days

    Changes in LDL cholesterol, measured in mg/dL, from baseline to the end of intervention.

  6. Changes in HDL cholesterol

    Time frame: 14 days

    Changes in HDL cholesterol, measured in mg/dL, from baseline to the end of intervention.

  7. Changes in triacylglycerols

    Time frame: 14 days

    Changes in triacylglycerols, measured in mg/dL, from baseline to the end of intervention.

  8. Changes in high sensitivity PCR

    Time frame: 14 days

    Changes in high sensitivity PCR, measured in mg/dL, from baseline to the end of intervention.

  9. Changes in expired breath H2

    Time frame: 14 days

    Changes in expired breath H2, measured in ppm, from baseline to the end of intervention.

  10. Changes in expired breath CH4

    Time frame: 14 days

    Changes in expired breath CH4, measured in ppm, from baseline to the end of intervention.

  11. Changes in faecal butyrate

    Time frame: 14 days

    Changes in faecal butyrate, measured in M, from baseline to the end of intervention.

  12. Changes in faecal acetate

    Time frame: 14 days

    Changes in faecal acetate, measured in M, from baseline to the end of intervention.

  13. Changes in faecal alkaline phosphatase (ALP)

    Time frame: 14 days

    Changes in faecal ALP, measured in mg/g faeces, from baseline to the end of intervention.

  14. Changes in faecal LPS

    Time frame: 14 days

    Changes in faecal LPS, measured in EU/mL, from baseline to the end of intervention.

  15. Changes in faecal calprotectin

    Time frame: 14 days

    Changes in faecal calprotectin, measured in µg/g faeces, from baseline to the end of intervention.

Sponsors and collaborators

Lead sponsor

Universidade Nova de Lisboa

Other

Registry information

Official study title

The Effect of Daily Consumption of a Fruit Juice on Acute Satiety Response and Gut Microbiota Changes in Healthy Adults

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
May 3, 2023
Registry last updated
May 3, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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