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Completed

NCT Number: NCT04683900

Mediterranean Diet Intervention to Improve Gastrointestinal Function in Parkinson's Disease a Randomized, Controlled, Clinical Trial

This is a 10-week randomized, controlled study to investigate the effect of a Mediterranean diet intervention on gastrointestinal function in Parkinson's disease. After a 2-week run-in period, participants will be instructed to receive standard of care for constipation or receive standard of care + follow a Mediterranean diet for 8 weeks and answer daily and weekly questionnaires. Nutritional and neurological evaluations and stool samples will be collected at 0, 4 and 8 weeks.

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Key information

Conditions

Parkinson Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Constipation Inflammation Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinsonian Disorders Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive Synucleinopathies

Age range

40 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Florida

Gainesville, Florida, 32611, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Physician-diagnosed Parkinson's disease aged 40-85 years
  • Drug naïve or on stable dosage of Parkinson's medications with no plans to change for the duration of the study protocol
  • Hoehn & Yahr stage =<2.5 in the clinical "ON" state
  • Constipation syndrome scores >=2.0 based on the GSRS
  • Consume <20 grams of fiber daily based on the Block Fruit/Vegetable/Fiber screener
  • Able to complete informed consent in English
  • Willing to maintain habitual diet through the pre-baseline period.
  • Willing to make dietary changes to follow a Mediterranean diet and/or receive standard of care for constipation during the intervention period.
  • Willing to complete daily and weekly questionnaires and 12 dietary recalls over approximately 10 weeks.
  • Able to provide stool samples during the study collection periods.
  • Willing to avoid strenuous exercise and alcohol such as beer, wine, and cocktails 24 hours prior to each of the 3 study visits.
  • Able to fast (no food or drink, except water, or decaf tea) at least 12 hours before each study visit
  • Willing to discontinue taking prebiotic, herbal, or high-dose vitamin or mineral supplements that may impact inflammation during the pre-baseline period and throughout the study protocol.

Exclusion criteria

  • Atypical or secondary Parkinsonism
  • Underweight (BMI <18.5)
  • History of deep brain stimulation (DBS) surgery
  • Regular use of enemas or suppositories to alleviate constipation (e.g., >1 time per week)
  • Use of another investigational product within 3 months of the screening visit
  • Antibiotic or probiotic supplement use within 2 months from the day of stool collection
  • Currently being treated for a physician-diagnosed GI disease or condition other than constipation, irritable bowel disease, gastroparesis, reflux or diverticular disease

Treatment and study plan

Standard of care + Mediterranean diet (intervention)

Other

Participants will receive a constipation management handout that is distributed regularly to patients who present with constipation symptoms at an outpatient neurology clinic. The handout recommends increasing fluids daily, as well as increasing physical activity and dietary fiber intake. Laxative medications and recommendations for usage are included.

Participants will be instructed to include the following in their diet: a) abundant use of olive oil for cooking and dressing dishes; b) consume ≥2 daily servings of vegetables; c) ≥2-3 daily serving of fruits; d) ≥3 weekly servings of legumes; e) ≥3 weekly servings of fish/seafood; f) ≥3 weekly serving of nuts/seeds; g) select white instead of red or processed meats; h) cook at least twice a week with sofrito. Limit consumption of cream, butter, processed meat, sugared beverages, industrial bakery products and desserts, and French fries or chips. For usual drinkers, the main source of alcohol should be wine.

Standard of care (Control)

Other

Participants will receive a constipation management handout that is distributed regularly to patients who present with constipation symptoms at an outpatient neurology clinic. The handout recommends increasing fluids daily, as well as increasing physical activity and dietary fiber intake. Laxative medications and recommendations for usage are included.

Primary outcomes

  1. GSRS Constipation Syndrome Score

    Time frame: 10 weeks

    The difference between mean change (final - baseline) in constipation syndrome scores for the Med diet versus control diet.

Secondary outcomes

  1. Stool Frequency

    Time frame: Each week up to 10 weeks

    Compare the number of stools between the intervention and control groups

  2. Stool Form

    Time frame: Each day up to 10 weeks

    Compare stool form, as measured by the Bristol Stool Form Scale (BSFS), between the intervention and control groups. The BSFS is scored between 1 (hard stool) - 7 (liquid stool).

  3. Laxative Usage

    Time frame: Each week up to 10 weeks

    Compare number of days using laxative medications between the intervention and control groups.

  4. Digestive Health

    Time frame: Every week up to 10 weeks

    Weekly GI symptoms assessed using the Gastrointestinal Symptom Rating Scale (GSRS). The GSRS consists of 15 questions related to 5 syndromes, constipation, diarrhea, reflux, abdominal pain, and indigestion. Symptoms are scored 1=no discomfort to 7=very severe discomfort. Scores from each of the 15 questions are summed for the total GSRS score.

  5. Quality of Life Related to Digestive Health

    Time frame: Every week up to 10 weeks

    Weekly GI experiences assessed using an in-house Digestion-Associated Quality of Life questionnaire.

  6. Fecal Microbial Diversity

    Time frame: Baseline (Week 0); Midpoint (Week 4); Final (Week 8)

    Changes in fecal microbial composition and diversity (i.e. alpha and beta diversity) will be assessed.

  7. Fecal Microbial Quantitative Polymerase Chain Reaction (qPCR)

    Time frame: Baseline (Week 0); Midpoint (Week 4); Final (Week 8)

    Changes in fecal microbial composition to quantify bacterial species of interest (e.g., F. prausnitzii, Prevotella, Roseburia, Bilophila, Akkermansia, etc.) will be assessed.

  8. Intestinal Inflammation and Permeability

    Time frame: Baseline (Week 0); Midpoint (Week 4); Final (Week 8)

    Changes in fecal calprotectin and zonulin will be assessed using enzyme-linked immunosorbent assay

Other outcomes

  1. Mediterranean diet adherence

    Time frame: Each week up to 10 weeks

    Compare Mediterranean diet adherence scores using the 14-Item Mediterranean diet adherence screener (MEDAS) between groups

  2. Dietary Fiber Intake

    Time frame: Baseline (Week 0); Midpoint (Week 4); Final (Week 8)

    Changes in dietary fiber intake as measured by averaged 4-day dietary recalls using the Automated Self-Administered 24-hour dietary recall (ASA-24) between groups

  3. Body weight

    Time frame: Baseline (Week 0); Midpoint (Week 4); Final (Week 8)

    Changes in body weight between groups

  4. Body Composition (Fat Free Mass)

    Time frame: Baseline (Week 0); Midpoint (Week 4); Final (Week 8)

    Changes in fat free mass using bio-impedance spectroscopy (BIS) between groups

  5. Handgrip strength

    Time frame: Baseline (Week 0); Midpoint (Week 4); Final (Week 8)

    Changes in handgrip strength will be assessed using a hand dynamometer between groups

  6. Quality of Life (QOL)

    Time frame: Baseline (Week 0); Midpoint (Week 4); Final (Week 8)

    Changes in QOL will be assessed using the Parkinson's Disease Quality of life -39 (PDQ-39)

  7. Anxiety

    Time frame: Baseline (Week 0); Midpoint (Week 4); Final (Week 8)

    Changes in symptoms of anxiety will be assessed using the Hamilton Anxiety Rating Scale

  8. Depression

    Time frame: Baseline (Week 0); Midpoint (Week 4); Final (Week 8)

    Changes in symptoms of anxiety will be assessed using the Hamilton Depression Rating Scale

  9. Physical Activity

    Time frame: Baseline (Week 0); Midpoint (Week 4); Final (Week 8)

    Changes in MET minutes will be assessed using the International Physical Activity Questionnaire (IPAQ).

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Registry information

Official study title

Mediterranean Diet Intervention to Improve Gastrointestinal Function in Parkinson's Disease: a Randomized, Controlled, Clinical Trial

Acronym: MEDI-PD

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Dec 24, 2020
Registry last updated
Jul 12, 2022

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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