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Weight LossPronokalNCT03530501

Effect of Very-low Calorie Diet and Synbiotic Supplementation in Gut Microbiota (Pronokal Method)

A study testing Diet, Synbiotic1 and Synbiotic2 in people with Weight Loss and Inflammation, run by Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Weight Loss, Inflammation
What is being tested?
Diet, Synbiotic1 and Synbiotic2
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
33 participants
Where
1 siteSpain
Study dates
29 Aug 2016to 13 Mar 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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
Show all 13Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Spain1 site

  • Hospital Universitario Virgen de la Victoria

    Málaga, 29010

Other trials in Spain

About this study

Official title: Effects of Very-low Ketogenic Diet in Gut Microbiota and Its Restitution With the Use of Synbiotic Supplementation in Patients Following a Weight Loss Programme (Pronokal Method)

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

Read the detailed description

All participants followed a very-low-calorie ketogenic diet according to a commercial weight loss program (Pronokal method), which includes lifestyle and behavioural modification support. This method is based on high-biological-value protein preparations which contained 15 g protein, 4 g carbohydrates, 3 g fat and 50 mg docosahexaenoic acid, and provided 90-110 kcal. The study was divided in two phases. The first phase consists of a very-low-calorie ketogenic diet (600-800 kcal/day), low in carbohydrates and lipids. Throughout this ketogenic phase, supplements of vitamins and minerals such as K, Na, Mg, Ca and omega-3 fatty acids were provided. In this study the ketogenic step was maintained for 2 months. Then, the patients started a low-calorie diet (800-1500 kcal/day) which lasted two months.

During the first phase consisting of a very-low-calorie ketogenic diet, subjects were randomly divided into two groups, the treatment group who received synbiotic supplementation as capsules, a complex of B. lactis, Lactobacillus rhamnosus, B. longum ES1 and prebiotics fiber (synbiotic 1) and the control group who received a placebo. During the second phase consisting of a low-calorie diet, the treatment group received synbiotic supplementation as capsules consisting of B. animalis subsp. lactis and prebiotics fiber (synbiotic 2) (synbiotic1 + synbiotic 2 group), while the control group was divided into two groups: one continued receiving a placebo (control group) whilst the other group received synbiotic 2 (placebo + synbiotic2 group).

Being tested
Diet, Synbiotic1, Synbiotic2
Keywords
microbiota, obesity
Medical subject headings
Weight Loss, Inflammation, Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DietOther

    Very low calorie ketogenic diet followed by low calorie diet

  • Synbiotic1Dietary supplement

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

  • Synbiotic2Dietary supplement

    1. animalis subsp. lactis and prebiotics fiber
Study groups in NCT03530501
Study groupRoleWhat they receive
PlaceboPlacebo comparatorVery low calorie ketogenic diet followed by low calorie diet
Receives: Other: Diet
Synbiotic1+synbiotic2ExperimentalVery low calorie ketogenic diet supplemented with synbiotic 1 followed by low calorie diet supplemented with synbiotic2
Receives: Other: Diet; Dietary Supplement: Synbiotic1; Dietary Supplement: Synbiotic2
placebo +synbiotic2ExperimentalVery low calorie ketogenic diet supplemented with placebo followed by low calorie diet supplemented with synbiotic2
Receives: Other: Diet; Dietary Supplement: Synbiotic2

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: At baseline and at 4 months

Secondary outcomes (3)

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

    Blood samples were collected at baseline and at the end of study. Plasma Zonulin levels were measured by enzyme linked immunosorbent assay

    Measured: At baseline and at 4 months

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

    Blood samples were collected at baseline and at the end of study. Plasma C-reactive protein levels were measured by enzyme linked immunosorbent assay

    Measured: At baseline and at 4 months

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

    Blood samples were collected at baseline and at the end of study. Plasma lipopolysaccharide binding protein levels were measured by enzyme linked immunosorbent assay

    Measured: At baseline and at 4 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 May 2018
  2. Study start29 Aug 2016
  3. Primary completion13 Mar 2018
  4. Study completion13 Mar 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Care provider
Enrolment
33 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03530501
Sponsor's protocol ID
JGA-BIOPNK-2016-01
Acronym
Pronokal
Status last verified
Apr 2018
First submitted
5 Apr 2018
Last updated
21 May 2018
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 31298466

Questions about this trial

What is this clinical trial studying?

A study testing Diet, Synbiotic1 and Synbiotic2 in people with Weight Loss and Inflammation, run by Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 May 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes produced in the composition and diversity of gut microbiota by the use of synbiotics during a dietary intervention (time frame: At baseline and at 4 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03530501, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 May 2018.

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