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Investigating the Effects of MIND Diet with Restricted Calories and Probiotic Supplement on Fertility, Sexual Performance and Quality of Sexual Life in Overweight and Obese Males

Protocol summary

Study aim
Determining the effect of MIND diet with restricted calories and probiotic supplement on spermogram parameters, serum levels of androgens, sperm DNA fragmentation, sexual performance and quality of sexual life in overweight and obese males.
Design
Clinical trial with a control group, with parallel groups, double-blind, randomized, phase 3 on 84 patients. Random sequence will be generated using Sealedenvelope.com website.
Settings and conduct
The present study is a randomized and blinded clinical trial that is conducted for 3 months on 84 overweight and obese men referred to KERCADRS Cohort Center in Kerman and Afzalipour Infertility Treatment Research Center in Kerman. Randomization of the allocation of samples to the intervention or control group is done based on classified blocks. People will be divided into 4 groups and will receive diet and probiotic supplements from the beginning to the end of the study.
Participants/Inclusion and exclusion criteria
Criteria for entering the study: • Married men • Age 20-45 years • Men with a body mass index greater than 25 • Failure to use probiotic supplements in the last 3 months Non-entry criteria: • Having Azoospermia, Cryptorchidism or Microorchidism • Having a varicocele • History of vasectomy • Men with tobacco, alcohol or drug use • Having anatomical abnormalities of the reproductive system
Intervention groups
The four studied groups include: A) MIND diet group with restricted calories + probiotic supplement B) MIND diet group with restricted calories + placebo C) The group receiving the standard low-calorie diet + probiotic supplement D) Group receiving standard low-calorie diet + placebo (control group)
Main outcome variables
Semen parameters (number, motility, percentage of live sperm, morphology and DNA fragmentation index of sperm), serum levels of androgens, average sexual performance score and sexual life quality score

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20240313061277N1
Registration date: 2024-03-31, 1403/01/12
Registration timing: prospective

Last update: 2024-03-31, 1403/01/12
Update count: 0
Registration date
2024-03-31, 1403/01/12
Registrant information
Name
Ali Shamsigoushki
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3800 2418
Email address
shamsia4001@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-05-04, 1403/02/15
Expected recruitment end date
2025-01-04, 1403/10/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the Effects of MIND Diet with Restricted Calories and Probiotic Supplement on Fertility, Sexual Performance and Quality of Sexual Life in Overweight and Obese Males
Public title
Investigating the Effect of MIND Diet with Restricted Calories and Probiotic Supplement on Fertility in Overweight and Obese Males
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Having informed consent Married adult men Ages 20-45 years Overweight and obese men with a body mass index greater than 25 Not using probiotic supplements in the last 3 months
Exclusion criteria:
Suffering from Azoospermia Having a Varicocele Suffering from Cryptorchidism Suffering from Microorchidism History of Vasectomy Men taking drugs that harm spermatogenesis such as sulfasalazine Men with tobacco, alcohol or drug use Getting infections and anatomical abnormalities of the genital system Suffering from cancer and chronic diseases
Age
From 20 years old to 45 years old
Gender
Male
Phase
3
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 84
Randomization (investigator's opinion)
Randomized
Randomization description
The randomization method in this study is block randomization, the random sequence is generated by a statistical consultant. In this method, blocks of even size are created, and in these blocks, a quarter of the people in each block will be considered as belonging to one of the four groups. The random sequence will be generated using Sealedenvelope.com website. The generated sequence will be placed in closed, opaque, sealed and marked envelopes.
Blinding (investigator's opinion)
Double blinded
Blinding description
Using Closed, Opaque, Sealed, and Numbered Envelopes (SNOSE), the generated sequence will be encrypted. After checking the entry and non-entry criteria and obtaining informed consent, the researcher takes the envelopes in order from the mentioned sequence, writes the person's name behind them and then opens them and the person is assigned to the group written inside the envelope. People participating in the study will be studied randomly in one of four groups. The supplement and placebo will be given to people with the same appearance and packaging, so that the subjects and researchers will not know about the content of the packages. Finally, the person who will do the evaluation of the results will not know how to allocate people.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Mashhad University of Medical Sciences
Street address
Qurashi Building, University St., Mashhad, Razavi Khorasan
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948564
Approval date
2024-03-09, 1402/12/19
Ethics committee reference number
IR.MUMS.REC.1402.341

Health conditions studied

1

Description of health condition studied
Obesity and overweight
ICD-10 code
E66.0
ICD-10 code description
Obesity due to excess calories

Primary outcomes

1

Description
Semen parameters (concentration, motility, percentage of live sperm, morphology, sperm DNA fragmentation index)
Timepoint
Before and 3 months after the intervention
Method of measurement
Light microscope with 1000x magnification will be used to calculate movement, number of live sperm and morphology.

2

Description
Serum levels of androgens (total testosterone, free testosterone, dihydroepiandrosterone)
Timepoint
Before and 3 months after the intervention
Method of measurement
by ELISA method by monobind kits

3

Description
Sexual performance score
Timepoint
Before and 3 months after the intervention
Method of measurement
Male sexual performance questionnaire

4

Description
Sex life quality score
Timepoint
Before and 3 months after the intervention
Method of measurement
Men's Sexual Quality of Life Questionnaire: SQOL-M

Secondary outcomes

empty

Intervention groups

1

Description
The first intervention group: the group receiving MIND diet with restricted calories + probiotic supplement for 3 months. To adjust the diet, the energy needed by the person is obtained based on the Mifflin formula and 500-750 kcal will be deducted from it. The distribution percentage of macronutrients will include 50-55% carbohydrates, 30% fat and 15-20% protein. The MIND diet emphasizes ten components that are good for the brain, including green leafy vegetables, other vegetables, nuts, berries, legumes, especially beans, whole grains, fish (more than one serving per week), poultry (more than two servings per week). ), olive oil and wine, and five unhealthy components for the brain including red meat, butter and margarine, cheese, cakes and sweets, fast food and fried foods will be limited in this diet. In this study, the consumption of wine will not be considered due to the prohibition of its use in Iran, instead it is recommended to consume raisins and currants. People's diet will include 3 main meals and 3 snacks.
Category
Treatment - Drugs

2

Description
The second intervention group: the group receiving standard low-calorie diet + probiotic supplement for 3 months. To adjust the low-calorie diet, the energy needed by the person is obtained based on the Mifflin formula and 500-750 kcal will be deducted from it. The percentage distribution of macronutrients will include 50-55% carbohydrates, 30% fat and 15-20% protein, then the units of each food group are determined based on the standard diet. People's diet will include 3 main meals and 3 snacks.
Category
Treatment - Drugs

3

Description
The third intervention group: the group receiving MIND diet with restricted calories + placebo supplement for 3 months. To adjust the diet, the energy needed by the person is obtained based on the Mifflin formula and 500-750 kcal will be deducted from it. The distribution percentage of macronutrients will include 50-55% carbohydrates, 30% fat and 15-20% protein. The MIND diet emphasizes ten components that are good for the brain, including green leafy vegetables, other vegetables, nuts, berries, legumes, especially beans, whole grains, fish (more than one serving per week), poultry (more than two servings per week). ), olive oil and wine, and five unhealthy components for the brain including red meat, butter and margarine, cheese, cakes and sweets, fast food and fried foods will be limited in this diet. In this study, the consumption of wine will not be considered due to the prohibition of its use in Iran, instead it is recommended to consume raisins and currants. People's diet will include 3 main meals and 3 snacks.
Category
Treatment - Drugs

4

Description
Control group: group receiving standard low-calorie diet + placebo for 3 months. To adjust the low-calorie diet, the energy needed by the person is obtained based on the Mifflin formula and 500-750 kcal will be deducted from it. The percentage distribution of macronutrients will include 50-55% carbohydrates, 30% fat and 15-20% protein, then the units of each food group are determined based on the standard diet. People's diet will include 3 main meals and 3 snacks.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Afzalipour Infertility Research Center, Kerman
Full name of responsible person
Reza Rezvani
Street address
Imam Khomeini Highway, next to Shahid Bahonar University, Afzalipur Educational and Medical Center
City
Kerman
Province
Kerman
Postal code
7616913355
Phone
+98 34 3132 8000
Email
Shamsia4001@mums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohsen Tafaghodi Piadeh Gheibi
Street address
Research and Technology Vice Chancellor, Qurashi Building, next to Hoize Cinema, University St., Mashhad, Razavi Khorasan
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3841 1538
Email
Tafaghodim@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Ali Shamsi-goushki
Position
PhD Student
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Department of Nutrition, Faculty of Medicine, Ferdowsi University Campus, Azadi Square, Mashhad, Razavi Khorasan
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948564
Phone
+98 51 3882 7034
Email
Shamsia4001@mums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Ali Shamsi_goushki
Position
PhD Student
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Department of Nutrition, Faculty of Medicine, Ferdowsi University Campus, Azadi Square, Mashhad, Razavi Khorasan
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948564
Phone
+98 51 3882 7034
Email
Shamsia4001@mums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Ali Shamsi_goushki
Position
PhD Student
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Department of Nutrition, Faculty of Medicine, Ferdowsi University Campus, Azadi Square, Mashhad, Razavi Khorasan
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948564
Phone
+98 51 3882 7034
Email
Shamsia4001@mums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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