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Effect of a Very Low-Calorie Ketogenic Diet on Gut Microbiota and Fat Distribution

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ClinicalTrials.gov Identifier: NCT04019431
Recruitment Status : Recruiting
First Posted : July 15, 2019
Last Update Posted : July 15, 2019
Sponsor:
Information provided by (Responsible Party):
Lucio Gnessi, University of Roma La Sapienza

Brief Summary:
Short-term interventions that use very low-calorie ketogenic diets and meal replacements may be prescribed for selected overweight or obese patients with type 2 diabetes or prediabetes. Few, inconsistent data are available on protein intake from various sources on body weight, the composition of gut microbiota and metabolic outcomes in these patients. The aim of the present study is to compare efficacy, safety and effect on microbiota composition of short-term isocaloric VLCKDs using whey proteins, vegetable proteins or animal proteins in obese patients with diabetes or prediabetes. 50 obese diabetic/prediabetic patients will be randomly assigned to three isocaloric VLCKD regimens (≤800 kcal/day) containing either whey, plant or animal proteins for 45 days. Outcome measures will be anthropometric parameters, vital signs, metabolic profile, body composition and microbiota assessment.

Condition or disease Intervention/treatment Phase
Obesity Dietary Supplement: Whey protein, vegetable protein or animal protein Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Very Low-calorie Ketogenic Diet (VLCKD) Influences Taxonomic Composition of the Gut Microbiota and Visceral Adipose Tissue Distribution in Obese Patients With Type 2 Diabetes or Prediabetes Depending on Protein Source
Estimated Study Start Date : July 2019
Estimated Primary Completion Date : October 2019
Estimated Study Completion Date : November 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Whey protein
VLCKD (780 kcal/day) low in carbohydrates (<50 g per day) and lipids (only 10 g of olive oil per day) for 45 days. High-biological-value protein preparations will be given four times per day, based on whey protein.
Dietary Supplement: Whey protein, vegetable protein or animal protein
meal replacements or animal protein

Active Comparator: Vegetable proteins
VLCKD (780 kcal/day) low in carbohydrates (<50 g per day) and lipids (only 10 g of olive oil per day) for 45 days. High-biological-value protein preparations will be given four times per day, based on vegetal protein derived from soya or green peas or cereals.
Dietary Supplement: Whey protein, vegetable protein or animal protein
meal replacements or animal protein

Active Comparator: Animal proteins
VLCKD (780 kcal/day) low in carbohydrates (<50 g per day) and lipids (only 10 g of olive oil per day) for 45 days.Patients will be given four meals per day containing natural animal protein (meat, fish, eggs, dairy products without whey protein).
Dietary Supplement: Whey protein, vegetable protein or animal protein
meal replacements or animal protein




Primary Outcome Measures :
  1. Body Mass Index change from baseline [ Time Frame: 45 days ]
    Body Mass Index will be calculated at baseline and after 45 days


Secondary Outcome Measures :
  1. Fat mass percentage (%) change from baseline [ Time Frame: 45 days ]
    Fat mass percentage will be assessed by DXA at baseline and after 45 days

  2. Visceral adipose tissue (gr) change from baseline [ Time Frame: 45 days ]
    Visceral adipose tissue will be assessed by DXA at baseline and after 45 days

  3. Microbiome taxonomic composition change from baseline [ Time Frame: 45 days ]
    Change in abundance of gut microbiome will be measured with stool sample collections at baseline and after 45 days

  4. Fasting glucose level (mg/dL) change from baseline [ Time Frame: 45 days ]
    blood glucose will be measured at baseline and after 45 days

  5. Fasting Insulin level (mcU/mL) change from baseline [ Time Frame: 45 days ]
    insulin will be measured at baseline and after 45 days

  6. Fasting Cholesterol level (mg/dL) change from baseline [ Time Frame: 45 days ]
    Fasting Cholesterol will be measured at baseline and after 45 days

  7. Muscle strength (kg) change from baseline [ Time Frame: 45 days ]
    Muscle strength will be assessed with a handgrip test at baseline and after 45 days

  8. Quality of life (subjective unit) change from baseline [ Time Frame: 45 days ]
    Quality of life will be assessed through questionnaire

  9. Safety (subjective unit) change from baseline [ Time Frame: 45 days ]
    safety will be assessed through questionnaire



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Ages Eligible for Study:   50 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • obesity (BMI 30-40)
  • newly-diagnosed and untreated type 2 diabetes (fasting plasma glucose ≥ 126 mg/dL or HbA1c ≥ 6.5 mmol/L) or impaired fasting glycemia (fasting plasma glucose from 110mg/dl to 125mg/dl).
  • stable body weight in the previous 3 months

Exclusion Criteria:

known hypersensitivity to one or more components used in the protocol products; history of renal, cardiac, cerebrovascular or gastrointestinal diseases; psychiatric disturbances; hydroelectrolytic alterations, diagnosis of type 1 diabetes lack of informed consent; history of or planned weight loss surgery


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04019431


Contacts
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Contact: Lucio Gnessi, MD PhD +390649970721 lucio.gnessi@uniroma1.it
Contact: Mikiko Watanabe, MD +393483244207 mikiko.watanabe@uniroma1.it

Locations
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Italy
Sapienza University of Rome Recruiting
Roma, RM, Italy, 00161
Contact: Lucio Gnessi, MD PhD    0649970721    lucio.gnessi@uniroma1.it   
Contact: Mikiko Watanabe, MD       mikiko.watanabe@uniroma1.it   
Sponsors and Collaborators
University of Roma La Sapienza
Investigators
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Principal Investigator: Lucio Gnessi, MD PhD Sapienza University of Rome

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Responsible Party: Lucio Gnessi, Principal Investigator, University of Roma La Sapienza
ClinicalTrials.gov Identifier: NCT04019431     History of Changes
Other Study ID Numbers: U1111-1236-5158
First Posted: July 15, 2019    Key Record Dates
Last Update Posted: July 15, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No