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

NCT04019431 | Completed

• 1 other identifier: U1111-1236-5158
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity

Outcome Measures

Primary Outcomes (1)

• Body Mass Index change from baseline

  Body Mass Index will be calculated at baseline and after 45 days

  45 days

Secondary Outcomes (9)

• Fat mass percentage (%) change from baseline

  45 days

• Visceral adipose tissue (gr) change from baseline

  45 days

• Microbiome taxonomic composition change from baseline

  45 days

• Fasting glucose level (mg/dL) change from baseline

  45 days

• Fasting Insulin level (mcU/mL) change from baseline

  45 days

Study Arms (3)

Whey protein

EXPERIMENTAL

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

Vegetable proteins

ACTIVE COMPARATOR

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

Animal proteins

ACTIVE COMPARATOR

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

Interventions

Whey protein, vegetable protein or animal protein DIETARY_SUPPLEMENT

meal replacements or animal protein

Animal proteins; Vegetable proteins; Whey protein

Eligibility Criteria

• Age: 50 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Roma La Sapienza: lead

Study Sites (1)

Sapienza University of Rome

Roma, RM, 00161, Italy

Location

Related Publications (1)

• Basciani S, Camajani E, Contini S, Persichetti A, Risi R, Bertoldi L, Strigari L, Prossomariti G, Watanabe M, Mariani S, Lubrano C, Genco A, Spera G, Gnessi L. Very-Low-Calorie Ketogenic Diets With Whey, Vegetable, or Animal Protein in Patients With Obesity: A Randomized Pilot Study. J Clin Endocrinol Metab. 2020 Sep 1;105(9):dgaa336. doi: 10.1210/clinem/dgaa336.

  PMID: 32484877 DERIVED

MeSH Terms

Conditions

Obesity

Interventions

Whey Proteins; Plant Proteins, Dietary

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Milk Proteins; Animal Proteins, Dietary; Dietary Proteins; Proteins; Amino Acids, Peptides, and Proteins; Whey; Milk; Dairy Products; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Plant Proteins

Study Officials

• Lucio Gnessi, MD PhD

  University of Roma La Sapienza

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 5, 2019
• First Posted: July 15, 2019
• Study Start: July 1, 2019
• Primary Completion: October 1, 2019
• Study Completion: November 1, 2019
• Last Updated: May 17, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)