Register a trial

Did you know?

The ANZCTR now automatically displays published trial results and simplifies the addition of trial documents such as unpublished protocols and statistical analysis plans.

These enhancements will offer a more comprehensive view of trials, regardless of whether their results are positive, negative, or inconclusive.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05723913




Registration number
NCT05723913
Ethics application status
Date submitted
17/01/2023
Date registered
13/02/2023

Titles & IDs
Public title
Postprandial Glucose Levels, Gut Microbiota and Supplementation With Functional Foods in Adults
Scientific title
Postprandial Glucose Levels, Gut Microbiota and Supplementation With Functional Foods in Adults
Secondary ID [1] 0 0
3312B
Universal Trial Number (UTN)
Trial acronym
PPGR
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Healthy 0 0
Nutritional and Metabolic Diseases 0 0
Condition category
Condition code
Metabolic and Endocrine 0 0 0 0
Metabolic disorders
Metabolic and Endocrine 0 0 0 0
Other metabolic disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - Dietary Supplement: A package containing a mix of functional foods

Experimental: Nutritional strategy based on functional foods - Participants will be provided with a nutritional strategy based on functional foods to use over the 2 week trial. These will be nopal, chía seeds, inulin, soy protein, agave extract and genistein.


Treatment: Other: Dietary Supplement: A package containing a mix of functional foods
Participants will be provided with a nutritional strategy based on functional foods to use over the 2 week trial. These will be nopal, chía seeds, inulin, soy protein, agave extract and genistein.
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Changes in postprandial glucose responses
Timepoint [1] 0 0
6 weeks
Primary outcome [2] 0 0
Changes in diversity analysis of intestinal microbiota with and without intervention with functional foods
Timepoint [2] 0 0
6 weeks
Secondary outcome [1] 0 0
Changes in metabolite profiles of urine with and without intervention with functional foods
Timepoint [1] 0 0
6 weeks
Secondary outcome [2] 0 0
Feasibility of the functional food treatment decision algorithm. Proportion of patients with presumed improvement in postprandial glucose response who have completed the algorithm.
Timepoint [2] 0 0
2 weeks

Eligibility
Key inclusion criteria
* Male and female
* Adults between 18 and 60 years of age.
* The signing of the informed consent.
Minimum age
18 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
* Patients with any type of diabetes.
* Patients with high blood pressure.
* Patients with acquired diseases secondarily producing obesity and diabetes.
* Patients who have suffered a cardiovascular event.
* Patients with gastrointestinal diseases.
* Weight loss > 3 kg in the last 3 months.
* Catabolic diseases such as cancer and acquired immunodeficiency syndrome.
* Pregnancy status.
* Drug treatment:

* Antihypertensive drugs or treatment (thiacycline, loop or potassium-sparing diuretics, angiotensin-converting enzyme inhibitors, angiotensin II receptor blockers, alpha blockers, calcium antagonists, beta blockers).
* Treatment with hypoglycemic agents (sulfonylureas, biguanides, incretins) or insulin and antidiabetic drugs.
* Treatment with statins, fibrates or other drugs to control dyslipidemia.
* Use of antibiotics in the three months prior to the study.
* Use of steroid drugs, chemotherapy, immunosuppressants, or radiation therapy.
* Anorexigenic or that accelerate weight loss such as sibutramine or orlistat.
* Supplements with any of the functional foods used in the study.
* Probiotic, prebiotic or symbiotic supplements.

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
7/06/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2025
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
Mexico
State/province [1] 0 0
Mexico City

Funding & Sponsors
Primary sponsor type
Other
Name
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Fundación Gonzalo Río Arronte
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Armando R Tovar, Doctor
Address 0 0
Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubiran
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Armando R Tovar, Doctor
Address 0 0
Country 0 0
Phone 0 0
52 5554870900
Fax 0 0
Email 0 0
tovar.ar@gmail.com
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05723913