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Completed

NCT Number: NCT04529161

Olfactory and Taste Changes During Fasting Mimicking Diet (FMD)

Literature experiences demonstrated the impact of medically-assisted pulsed fasting on olfactory behavior in both the animal and human models and - conversely - the lack of homogeneous results linked - up to now - to administrations of pulsed fasting which are not widely codified.

Thus, objective of this study protocol is to evaluate the olfactory-gustatory aspects and blood patterns of a group of subjects suffering from obesity / overweight after a 6-month period of Fasting Mimicking Diet (FMD) (Group A) - consisting of a caloric restriction regimen - compared to a group of homogeneous subjects observing their own eating habits (Group B) which - according to a "cross-over" model - will undergo FMD in the following semester during which the subjects belonging to Group A will observe their eating habits.

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Key information

Conditions

Diet, Healthy Body Weight Nervous System Diseases Neurologic Manifestations Nutrition Disorders Nutritional and Metabolic Diseases Obesity Olfaction Disorders Overnutrition Overweight Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Rome Tor Vergata - UNITER Onlus

Roma, Rome, 00012, Italy

About this study

A group of obese and/or overweighted patients who did not pass screening criteria (BMI andor neuropsychological testing) to undergo surgical procedure aimed at reducing weight (grastrectomy, bypass, other…) will follow a 6-month period of FMD followed by 6-month period of routinary eating behaviour (Group A) or viceversa (Group B).

All the patients will undergo - before and after the administration of FMD or the routinary diet habit - a battery of:

  • Olfactory test (sniffin' stick test)
  • Taste Test (Taste strips)
  • Blood Samples including: IGF-1, IGFBP1/3, VEGF, insulin, adiponectin, c reactive protein, plasma ghrelin, serum glucose, alanine aminotransferase (ALT) and aspartate aminotransferase (AST), total cholesterol, triglycerides (TGs), high density lipoprotein (HDL) cholesterol and low-density lipoprotein (LDL) cholesterol, erythrocyte sedimentation rate (ESR), conjugated and unconjugated bilirubin, uraemia, serum creatinine and leptin.
  • anthropometeric measures, including height and body weight, BMI, waist circumference (WC), estimation of fat mass (FM, in % and Kg), skeletal muscle mass (MM, in % and Kg) and grade of visceral fat (VF level)

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • subjects excluded from bariatric surgical treatment for failing to neuropsychological tests or for co-morbidities that would excessively increase the intra-operative and/or
  • non-responders to any previous dietary / nutritional treatment
  • BMI > 25

Exclusion criteria

  • Subjects under the age of 18 and over 75 years.
  • Subjects already undergoing bariatric surgical treatment
  • Women who are pregnant or breastfeeding
  • Hormonal therapies and / or chemotherapy in place
  • Active mental or psychiatric illness
  • Addiction to drugs of abuse or alcohol
  • other acute or chronic systemic disorders
  • Severe hypertension (systolic blood pressure> 200 mm Hg and / or diastolic blood pressure> 105 mm Hg)
  • Visual impairment (for completion of neuropsychological tests)
  • Inability to complete home FMD

Treatment and study plan

Fasting mimicking diet (FMD)

Dietary Supplement

The treatment consists in the self-administration of FMD at home - closely followed by the neuropsychologist by phone and by a properly trained nutritionist in the FMD sector - for 5 days a month for 6 consecutive months.

Routinary diet habits

Dietary Supplement

Subjects will follow their routinary eating habits for 6 consecutive months

Primary outcomes

  1. Sniffing stick test change

    Time frame: From date of randomization until the date of first documented progression, assessed at the 6th and 12 months

    Quantitative screening of olfactory performance

  2. Taste Strips

    Time frame: From date of randomization until the date of first documented progression, assessed at the 6th and 12 months

    Quantitative assessment of taste performance

Secondary outcomes

  1. Incidence of abnormal laboratory tests results

    Time frame: From date of randomization until the date of first documented progression, assessed at the 6th and 12 months

    serum glucose

  2. Incidence of abnormal laboratory tests results

    Time frame: From date of randomization until the date of first documented progression, assessed at the 6th and 12 months

    Serum/plasma growth factors: IGF-1

  3. Incidence of abnormal laboratory tests results

    Time frame: From date of randomization until the date of first documented progression, assessed at the 6th and 12 months

    Serum/plasma growth factors: IGFBP1/3

  4. Incidence of abnormal laboratory tests results

    Time frame: From date of randomization until the date of first documented progression, assessed at the 6th and 12 months

    Serum/plasma growth factors: insulin

  5. Incidence of abnormal laboratory tests results

    Time frame: From date of randomization until the date of first documented progression, assessed at the 6th and 12 months

    Serum/plasma growth factors: VEGF

  6. Incidence of abnormal laboratory tests results

    Time frame: From date of randomization until the date of first documented progression, assessed at the 6th and 12 months

    plasma ghrelin.

  7. Incidence of abnormal laboratory tests results

    Time frame: From date of randomization until the date of first documented progression, assessed at the 6th and 12 months

    Serum/plasma inflammatory markers: adiponectin

  8. Incidence of abnormal laboratory tests results

    Time frame: From date of randomization until the date of first documented progression, assessed at the 6th and 12 months

    Serum/plasma inflammatory markers: c reactive protein

  9. Incidence of abnormal laboratory tests results

    Time frame: From date of randomization until the date of first documented progression, assessed at the 6th and 12 months

    alanine aminotransferase

  10. Incidence of abnormal laboratory tests results

    Time frame: From date of randomization until the date of first documented progression, assessed at the 6th and 12 months

    aspartate aminotransferase

  11. Incidence of abnormal laboratory tests results

    Time frame: From date of randomization until the date of first documented progression, assessed at the 6th and 12 months

    total cholesterol

  12. Incidence of abnormal laboratory tests results

    Time frame: From date of randomization until the date of first documented progression, assessed at the 6th and 12 months

    triglycerides

  13. Incidence of abnormal laboratory tests results

    Time frame: From date of randomization until the date of first documented progression, assessed at the 6th and 12 months

    high density lipoprotein cholesterol

  14. Incidence of abnormal laboratory tests results

    Time frame: From date of randomization until the date of first documented progression, assessed at the 6th and 12 months

    low-density lipoprotein cholesterol

  15. Incidence of abnormal laboratory tests results

    Time frame: From date of randomization until the date of first documented progression, assessed at the 6th and 12 months

    erythrocyte sedimentation rate

  16. Incidence of abnormal laboratory tests results

    Time frame: From date of randomization until the date of first documented progression, assessed at the 6th and 12 months

    conjugated and unconjugated bilirubin

  17. Incidence of abnormal laboratory tests results

    Time frame: From date of randomization until the date of first documented progression, assessed at the 6th and 12 months

    uraemia

  18. Incidence of abnormal laboratory tests results

    Time frame: From date of randomization until the date of first documented progression, assessed at the 6th and 12 months

    serum creatinine

  19. Incidence of abnormal laboratory tests results

    Time frame: From date of randomization until the date of first documented progression, assessed at the 6th and 12 months

    leptin

  20. anthropometric measures

    Time frame: From date of randomization until the date of first documented progression, assessed at the 6th and 12 months

    height

  21. anthropometric measures

    Time frame: From date of randomization until the date of first documented progression, assessed at the 6th and 12 months

    weight

  22. anthropometric measures

    Time frame: From date of randomization until the date of first documented progression, assessed at the 6th and 12 months

    body mass index

  23. anthropometric measures

    Time frame: From date of randomization until the date of first documented progression, assessed at the 6th and 12 months

    waist circumference

  24. anthropometric measures

    Time frame: From date of randomization until the date of first documented progression, assessed at the 6th and 12 months

    estimation of fat mass

  25. anthropometric measures

    Time frame: From date of randomization until the date of first documented progression, assessed at the 6th and 12 months

    estimation of skeletal muscle mass

  26. anthropometric measures

    Time frame: From date of randomization until the date of first documented progression, assessed at the 6th and 12 months

    estimation of grade of visceral fat

Sponsors and collaborators

Lead sponsor

Uniter Onlus

Other

Collaborators

  • University of Rome Tor Vergata

Registry information

Official study title

Changes in Olfactory and Taste Behavior in Overweight / Obese Subjects Undergoing Fasting Mimicking Diet (FMD)

Acronym: FMD1

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Aug 27, 2020
Registry last updated
Mar 12, 2024

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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