Evaluation of the satiating and probiotic effect of goat cheese in volunteers on a weight control regimen: A randomized controlled trial

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General information

Section to complete general information about the trial: scientific and public title, protocol identifiers, sponsors and Source(s) of Monetary or Material Support.

Acronym of Public Title:

NUTRICHEESE

Scientific title:

Evaluation of the satiating and probiotic effect of goat cheese in volunteers on a weight control regimen: A randomized controlled trial

Acronym of Scientific Title:

NUTRICHEESE

Secondary indentifying numbers:

Not applicable

Issuing authority of the secondary identifying numbers:

Not applicable

Source(s) of monetary or material support:

National Polytechnic Institute (IPN) SIP 20250980

Authorization for beginning

Section to complete information about the regulatory approval of clinical trial: regulatory agency name, approval date and reference number in the agency.

Regulatory instance to authorize the initiation of the study:

Only approved by Ethics Committees

Principal investigator

Section to complete information about Email address, telephone number and postal address of the Principal Investigator.

First name:

Ana

Midle name:

Maria

Last name:

Sifuentes Rincon

Medical Specialty :

Biomedical Researcher in Animal Digestive Nutrigenomics and Microbiomics

Affiliation:

Genomic Biotechnology Center – National Polytechnic Institute

Postal address:

Boulevard del Maestro N/A, Narciso Mendoza

City:

Reynosa

Country:

Mexico

Zip Code:

88710

Telephone:

+52-8999243627 ext. 87723

Email address:

asifuentes@ipn.mx

Clinical sites to participate

Section to complete the data related to the clinical sites involved in the trial: site and responsible investigator for every site.

Countries of recruitment:

Mexico

Clinical sites:

Not applicable

Recruitment status

Section to complete information about the recruitment status and the date of first enrolment subject

Recruitment status:

Pending

Date of first enrollment:

19/11/2025

Health condition and Intervention

Section to complete information about the primary medical condition(s) or problem(s) studied and, a characteristics of the intervention(s).

Health condition(s) or Problem(s) studied:

Overweight and obesity

Health condition(s) code:

Healthy Volunteers

Obesity

Overweight

Nutrition Disorders

Nutritional and Metabolic Diseases

Body Weight

Intervention(s):

Group A (Experimental): 80 g of goat cheese with lower content of fat three days a week for fourth weeks, prohibited consuming milk, yogurt, cheese. Group B (Control): 80 g of goat cheese with higher content of fat three days a week for fourth weeks, prohibited consuming milk, yogurt, cheese.

Intervention code:

Cheese

Diet, Food, and Nutrition

Intervention keyword:

goat cheese

Outcomes and Timepoint

Section to complete information about primary and secondary outcomes including. It includes the metric or method of measurement used and, the time point for every outcome.

Primary outcome(s):

Acylated ghrelin. Measurement time: At the beginning and 4 weeks (before breakfast, at minute 30 and 120 after finishing breakfast).

Key secondary outcomes:

Anthropometric measurements and indexs: Weight (in Kg), Waist circumference (in cm), Abdominal circumference (in cm), Hip circumference (in cm), Waist-hip ratio (waist circumference/hip circumference in cm), Body Mass Index-BMI (Weight/(Height*Height). (Weight measured in Kg and height in m) measurement time: At baseline, at 2 and 4 weeks. Satiety (VAS) Measurement time: before breakfast, at minute 30 and 120 after finishing breakfast. Bacterial diversity Measurement time: at baseline, at 2, 3 and 4 weeks. Plasma lipid profile (Total cholesterol, Triglycerides, very low, low and high density lipoproteins (values in mg/dL)), measurement time: At baseline and 4 weeks. Nutrigenetic and nutrigenomic analysis measurement time: At baseline and 4 weeks. HOMA-IR index, measurement time: At baseline and 4 weeks.

Selection criterias

Section to complete information about the inclusion and exclusion criteria for participant selection, including age and gender.

Gender:

Male/Female

Minimum age:

18 years

Maximum age:

55 years

Inclusion criteria:

1. Adults: Women and Men 2. Nationality of any kind 3. Body mass index ≥25 4. Age: 18–55 years 5. Clinically healthy 6. Subjects from any socioeconomic or cultural group 7. Able to be informed about the study and willing to accept and sign written informed consent prior to the study 8. Consume goat cheese

Exclusion criteria:

1. Allergic and/or lactose intolerant 2. Type I or II diabetes 3. High blood pressure (defined as systolic blood pressure ≥140 or diastolic blood pressure ≥90 mmHg) 4. Cardiovascular disease, chronic kidney disease 5. Hyperlipidemia 6. Alcoholism and/or drug dependence 7. Smoker (>10 cigarettes per day) 8. Women who are pregnant or breastfeeding 9. Undergoing any medical treatment 10. Use of anorectic agents that act on the adrenergic, serotonergic, and adrenergic/serotonergic pathways. 11. Use of medications or supplements. 12. Insufficient motivation, as assessed by the interview, to remain in the clinical trial. 13. The volunteer no longer wishes to participate in the study 14. Inability to comply with the instructions of the investigation

Type of population:

Adults

Type of participant:

Healthy volunteers

Study design

Section to complete information about the characteristics of the study design.

Type study:

Interventional

Purpose:

Screening

Allocation:

Randomized controlled trial

Masking:

Double Blind

Control group:

Active

Study design:

Parallel

Phase:

N/A

Target sample size:

20

Contact for public queries

Section to complete information about Email address, telephone number and postal address of the contact who will respond to general queries, including information about current recruitment status

First Name:

Diana

Middle Name:

Alejandra

Last Name:

Vela Vasquez

Specialty:

Human nutrition

Affiliation:

Genomic Biotechnology Center – National Polytechnic Institute

Postal Address:

Blvrd del Maestro N/A, Narciso Mendoza

City:

Reynosa

Country:

Mexico

Zip Code:

88710

Telephone:

+52-8999243627

Email :

diana.w@outlook.com

Contact for scientific queries

Section to complete information about Email address, telephone number and postal address of the contact who will respond to scientific queries.

First Name:

Ana

Middle Name:

Maria

Last Name:

Sifuentes Rincon

Specialty:

Biomedical Researcher in Nutrigenomics and Animal Digestive Microbiotics

Affiliation:

Genomic Biotechnology Center – National Polytechnic Institute

Postal Address:

Boulevard del Maestro N/A, Narciso Mendoza

City:

Reynosa

Country:

Mexico

Zip Code:

88710

Telephone:

+52-8999243627

Email :

asifuentes@ipn.mx

Research Ethics Committees

Section to complete the data related to the review ethics committees.

Name of Research Ethics Committees:

Comité de Bioética de la Facultad de Medicina de la Universidad de Colima

Status of evaluation:

Approved

Status of evaluation date of Ethic Committee:

06/05/2025

Postal address of Ethic Committee :

Avenida Universidad 333, Colonia Las Viboras, Colima C.P:28040, Mexico

Telephone:

+52-3123161099

Email:

medicina@ucol.mx

About study completion

Section to complete the data related to the study completion.

Final enrolment number:

0

Study completion date:

19/12/2025

Registration and Update

Section to complete information about the name of Primary Registry, date of registration and the unique ID number assigned by the registry (RPCEC).

Primary registry:

RPCEC

Unique ID number:

RPCEC00000462

Date of Registration in Primary Registry:

17/11/2025

Record Verification Date:

2025/11/17

Next update date:

2026/11/17

Link to the spanish version:

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Evaluation of the satiating and probiotic effect of goat cheese in volunteers on a weight control regimen: A randomized controlled trial

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