NCT03530501

Brief Summary

The present study aimed to investigate the changes produced in gut microbiota by a very-low-calorie-ketogenic diet followed by a low calorie diet, whether the use of synbiotics is able to modulate gut microbiota diversity and composition and its association with gut permeability and inflammation

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
33

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 29, 2016

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 13, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 13, 2018

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

April 5, 2018

Completed
2 months until next milestone

First Posted

Study publicly available on registry

May 21, 2018

Completed
Last Updated

May 21, 2018

Status Verified

April 1, 2018

Enrollment Period

1.5 years

First QC Date

April 5, 2018

Last Update Submit

May 18, 2018

Conditions

Weight LossInflammation

Keywords

microbiotaobesity

Outcome Measures

Primary Outcomes (1)

  • Changes produced in the composition and diversity of gut microbiota by the use of synbiotics during a dietary intervention

    Fecal samples were collected at baseline and at the end of dietary intervention. Fecal DNA was extracted and Gut microbiota analysis was achieved by using high-throughput sequencing

    At baseline and at 4 months

Secondary Outcomes (3)

  • Changes in intestinal permeability markers produced by the use of synbiotics during a dietary intervention

    At baseline and at 4 months

  • Changes in intestinal inflammation markers produced by the use of synbiotics during a dietary intervention

    At baseline and at 4 months

  • Changes in microbial translocation markers produced by the use of synbiotics during a dietary intervention

    At baseline and at 4 months

Study Arms (3)

Placebo

PLACEBO COMPARATOR

Very low calorie ketogenic diet followed by low calorie diet

Other: Diet

Synbiotic1+synbiotic2

EXPERIMENTAL

Very low calorie ketogenic diet supplemented with synbiotic 1 followed by low calorie diet supplemented with synbiotic2

Other: DietDietary Supplement: Synbiotic1Dietary Supplement: Synbiotic2

placebo +synbiotic2

EXPERIMENTAL

Very low calorie ketogenic diet supplemented with placebo followed by low calorie diet supplemented with synbiotic2

Other: DietDietary Supplement: Synbiotic2

Interventions

DietOTHER

Very low calorie ketogenic diet followed by low calorie diet

PlaceboSynbiotic1+synbiotic2placebo +synbiotic2
Synbiotic1DIETARY_SUPPLEMENT

B. lactis, Lactobacillus rhamnosus, B. longum ES1 and prebiotics fiber

Synbiotic1+synbiotic2
Synbiotic2DIETARY_SUPPLEMENT

B. animalis subsp. lactis and prebiotics fiber

Synbiotic1+synbiotic2placebo +synbiotic2

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • body mass index ≥ 30 kg/m2
  • stable body weight in the previous 3 months

You may not qualify if:

  • Diabetes mellitus
  • Obesity induced by endocrine disorders or by drugs
  • Gastrointestinal disorders
  • Use of antibiotics, probiotic or prebiotic agent which could modify microbiota in the previous 3 months
  • Severe depression or any other psychiatric disease
  • Abuse of narcotics or alcohol
  • Severe hepatic insufficiency
  • Any type of renal insufficiency or gout episodes
  • Neoplasia
  • Previous events of cardiovascular or cerebrovascular disease
  • Renal lithiasis
  • Uncontrolled hypertension and hydroelectrolytic alterations
  • Females with child-bearing potential, who were pregnant, breast-feeding, intending to become pregnant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Universitario Virgen de la Victoria

Málaga, 29010, Spain

Location

Related Publications (1)

  • Gutierrez-Repiso C, Hernandez-Garcia C, Garcia-Almeida JM, Bellido D, Martin-Nunez GM, Sanchez-Alcoholado L, Alcaide-Torres J, Sajoux I, Tinahones FJ, Moreno-Indias I. Effect of Synbiotic Supplementation in a Very-Low-Calorie Ketogenic Diet on Weight Loss Achievement and Gut Microbiota: A Randomized Controlled Pilot Study. Mol Nutr Food Res. 2019 Oct;63(19):e1900167. doi: 10.1002/mnfr.201900167. Epub 2019 Aug 29.

    PMID: 31298466DERIVED

MeSH Terms

Conditions

Weight LossInflammationObesity

Interventions

Diet

Condition Hierarchy (Ancestors)

Body Weight ChangesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsPathologic ProcessesOverweightOvernutritionNutrition DisordersNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Nutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological Phenomena

Study Officials

  • José Manuel García-Almeida, MD

    Hospital Universitario Virgen de la Victoria

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 5, 2018

First Posted

May 21, 2018

Study Start

August 29, 2016

Primary Completion

March 13, 2018

Study Completion

March 13, 2018

Last Updated

May 21, 2018

Record last verified: 2018-04

Locations

ES(1)