Fertility IssuesFEASSTNCT05368194
Food Intake and Epigenetic Alteration in the Spermatozoa of Singletons and Twins
A study testing Isocaloric Unprocessed Diet, Isocaloric Processed Diet and Excess Calorie Unprocessed Diet in people with Fertility Issues and Nutrition, Healthy, run by University of Copenhagen at 1 site in Denmark.
Trial summary
The purpose of this study is to elucidate the role of acute dietary intake in male populations, and its impact on spermatozoa quality, integrity, content and epigenetic programming. Read more about this study
- Who is it for?
- Ages 20 to 35 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Fertility Issues, Nutrition, Healthy, Epigenetic Disorder
- What is being tested?
- Isocaloric Unprocessed Diet, Isocaloric Processed Diet and Excess Calorie Unprocessed Diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteDenmark
- Study dates
- 20 Oct 2021to 1 Jul 2022
- 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 20 to 35 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male
- 20 to 35 years old
- BMI 18.5 to 30
- Located within the Copenhagen region
- Fluent in English and/or Danish language
- Sperm concentration of >15 mil/mL according to the WHO's criteria for semen quality
Show all 9Show fewer
- Semen volume of >1.5mL mL according to the WHO's criteria for semen quality
- Clinician approval for participation in study
- Obtained informed consent
Who cannot join
- Self-reported history of serious or chronic illness
- Self-reported history of Obesity
- History of any food restrictions
- History of allergies to any food products
- History of disordered eating
- Record of current use of drugs, alcohol (>14 units per week and/or chronic binge drinking), and/or tobacco/nicotine products within the past month
Show all 13Show fewer
- Current use of prescription medication
- Engage in > 200 minutes of vigorous aerobic exercise per week
- Currently actively trying to conceive a child
- Diagnosis of infertility or disease of the reproductive system
- Evidence of dysregulated metabolism, characterized by the occurrence of any one of the following:
- Waist circumference >102 cm
- Blood pressure > 130/85 mm Hg
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The FEASST Study: Food Intake and Epigenetic Alteration in the Spermatozoa of Singletons and Twins
The purpose of this study is to elucidate the role of acute dietary intake in male populations, and its impact on spermatozoa quality, integrity, content and epigenetic programming.
Read the detailed description
The FEASST study has been designed to determine the impact of diet on the content, quality, and genetic programming of sperm. They are specifically interested in determining if a man's diet plays a role in influencing the health of his potential, future offspring through modifications of the sperm. Previous research has highlighted that certain dietary patterns in fathers-to-be may lead to variable health outcome for their children. However, the specific effect of a man's diet has yet to be fully understood. This study will help understand the impact of a man's diet on semen quality and potential downstream implications for child health, to aid in the development of dietary guidelines for future fathers-to-be.
For this study, male participants will be provided with two prescribed diets for three-week increments punctuated by a three month break. Health information and biological samples such as blood, semen, and saliva will be collected from study participants throughout the five month period. The diets will consist of a 'Processed diet', mimicking a traditional Western dietary intake pattern and an 'Unprocessed diet', based upon current dietary guidelines at quantities either adequate for the participants energetic needs or 500 calories in excess per day.
Patient information and samples will be collected before and after each dietary intervention. Aspects of patient health examined at various time points include weight, body fat percentage, sperm quality, epigenetic sequencing, serum levels of metabolic parameters, and survey information surrounding health history, typical diet, physical activity patterns, and treatment adherence.
- Being tested
- Isocaloric Unprocessed Diet, Isocaloric Processed Diet, Excess Calorie Unprocessed Diet, Excess Calorie Processed Diet
- Medical subject headings
- Infertility, Overnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Isocaloric Unprocessed DietDietary supplement
Intervention consists of an unprocessed diet meeting the Nordic and Australian Dietary Guidelines for food groups and micronutrients, wherein participants will be supplied with food providing kilocalories (kcal) in accordance with their nutritional needs as calculated based on theSchofield equation based on their weight, activity multiplier, and age at baseline. Almost all food and beverage products provided during this treatment to fall into the category of unprocessed/minimally processed foods and processed culinary ingredients in accordance with the NOVA classification system.
Isocaloric Processed DietDietary supplement
Intervention consists of a processed diet based on the dietary intake pattern resembling a processed western dietary intake pattern representative of the typical intake pattern of American men aged 19- 50, wherein participants will be supplied with food providing kcals in accordance with their nutritional needs as calculated based on the Schofield equation based on their height, weight, activity multiplier, and age at baseline. Almost all food and beverage products provided during this treatment to fall into the category of processed foods and ultra-processed foods in accordance with the NOVA classification system.
Excess Calorie Unprocessed DietDietary supplement
Intervention consists of an unprocessed diet meeting the Nordic and Australian Dietary Guidelines for food groups and micronutrients, wherein participants will be supplied with food providing kilocalories (kcal) in accordance with their nutritional needs as calculated based on theSchofield equation based on their weight, activity multiplier, and age at baseline, plus an excess of 500 kcal per day. Almost all food and beverage products provided during this treatment to fall into the category of unprocessed/minimally processed foods and processed culinary ingredients in accordance with the NOVA classification system.
Excess Calorie Processed DietDietary supplement
Intervention consists of a processed diet based on the dietary intake pattern resembling a processed western dietary intake pattern representative of the typical intake pattern of American men aged 19- 50, wherein participants will be supplied with food providing kcals in accordance with their nutritional needs as calculated based on the Schofield equation based on their height, weight, activity multiplier, and age at baseline, plus an excess of 500 kcal per day. Almost all food and beverage products provided during this treatment to fall into the category of processed foods and ultra-processed foods in accordance with the NOVA classification system.
| Study group | Role | What they receive |
|---|---|---|
| Isocaloric Arm | Experimental | Participants within the isocaloric arm will be provided with food provisions in accordance with their nutrition needs. Participants within this arm will be further randomised to the order of first and second dietary interventions for the crossover design; unprocessed diet or processed diet. Receives: Dietary Supplement: Isocaloric Unprocessed Diet; Dietary Supplement: Isocaloric Processed Diet |
| Excess Calorie Arm | Experimental | Participants within the excess calorie arm will be provided with food provisions in accordance with their nutrition needs plus an additional 500 kilocalories per day. Participants within this arm will be further randomised to the order of first and second dietary interventions for the crossover design; unprocessed diet or processed diet. Receives: Dietary Supplement: Excess Calorie Unprocessed Diet; Dietary Supplement: Excess Calorie Processed Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Spermatozoa DNA Methylation via Reduced Representation Bisulfite Sequencing
Differential methylation of CpG sites within mature spermatozoa determined from extracted genomic DNA which has undergone library preperation with Ovation® RRBS Methyl-Seq (NuGEN Technologies) and sequenced on a NextSeq Illumina platform.
Measured: 3 weeks
Secondary outcomes (29)
Sperm Concentration
Measured in million sperm per mL using LensHooke X1 Pro Semen Quality Analyser and Microscopy-based methodology
Measured: 3 weeks
Semen Volume
Measured in mL assuming the density of semen to be 1 g/ml
Measured: 3 weeks
Sperm Motility
Measured in precent of sperm classified as progressively motile and non-progressively motile using LensHooke X1 Pro Semen Quality Analyser and Microscopy-based methodology
Measured: 3 weeks
Spermatozoa smallRNA expression via sequencing of total smallRNA species
Differential expression of small RNA species within mature spermatozoa performed by generation of RNA sequencing libraries using NEXTFLEX® Small RNA-Seq Kit for Illumina (PerkinElmer), according to the manufacturer's instructions, and sequenced on a NextSeq Illumina platform.
Measured: 3 weeks
Weight
Measured in kilograms using a scale (Tanita DC 430 SMA)
Measured: 3 weeks
Body Mass Index (BMI)
Calculated based on height and weight measurement using the equation BMI=kg/m^2
Measured: 3 weeks
Waist Circumference
Measured in centimetres using a flexible measuring tape (SECA Measuring Tape 201 cm)
Measured: 3 weeks
Hip Circumference
Measured in centimetres using a flexible measuring tape (SECA Measuring Tape 201 cm)
Measured: 3 weeks
Body Fat Precentage
Measured using DEXA Scanner and Software (GE Lunar Prodigy)
Measured: 3 weeks
C-reactive protein (CRP)
Measured in milligrams per litre in serum
Measured: 3 weeks
Lipoproteins
Measuring high density lipoproteins and low density lipoproteins in milligrams per litre in plasma
Measured: 3 weeks
Total protein
Measured in grams per litre in serum
Measured: 3 weeks
Testosterone
Measured in nanograms per deciliter in plasma
Measured: 3 weeks
Follicle stimulating hormone (FSH)
Measured in international units per milliliter in serum
Measured: 3 weeks
Luteinizing hormone (LH)
Measured in international units per liters in plasma
Measured: 3 weeks
Progesterone
Measured in nanograms per milliliter in serum
Measured: 3 weeks
Estradiol
Measured in picograms per milliliter in serum
Measured: 3 weeks
Oestradiol
Measured in picograms per milliliter in serum
Measured: 3 weeks
Fasting Blood Glucose
Measured in whole blood using a handheld glucometer and test strip (Contour next Blood Glucose Meter and Blood Sugar Test strip)
Measured: 3 weeks
Insulin
Measured in microunits per milliliter in serum
Measured: 3 weeks
Haemoglobin A1c (HbA1c)
Measured in mmol/mol in plasma
Measured: 3 weeks
Blood pressure
Systolic and Diastolic blood pressure measured in mmHg using an automatic blood pressure cuff (Omron M6 Comfort Automatic Upper Arm Blood Pressure Monitor, 22-42cm)
Measured: 3 weeks
Leptin
Measured in ng/mL in plasma
Measured: 3 weeks
Glucagon-like peptide 1 (GLP-1)
Measured in pmol/L in plasma
Measured: 3 weeks
Gastric inhibitory peptide (GIP)
Measured in pg/mL in serum
Measured: 3 weeks
Glucagon
Measured in pg/mL in serum
Measured: 3 weeks
Ghrelin
Measured in pg/mL in plasma
Measured: 3 weeks
Fibroblast growth factor 21 (FGF-21)
Measured in pg/ml in serum
Measured: 3 weeks
Peripheral blood mononuclear cell (PBMC) DNA methylation via Reduced Representation Bisulfite Sequencing
Differential methylation of CpG sites within PBMCs determined from extracted genomic DNA which has undergone library preperation with Ovation® RRBS Methyl-Seq (NuGEN Technologies) and sequenced on a NextSeq Illumina platform.
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2022
- Study start20 Oct 2021
- Primary completion1 Jul 2022
- Study completion1 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fertility IssuesStudies of the same condition, open and under way.
- More trials run by University of CopenhagenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Copenhagen
- Sponsor type
- University, hospital or other
- Collaborators
- Deakin University, Monash Health
- Responsible party
- Sponsor
- Investigators
- Romain Barrès, PhD, Principal investigator, University of Copenhagen Novo Nordisk Foundation Center for Basic Metabolic Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05368194
- Sponsor's protocol ID
- H-20061598
- Acronym
- FEASST
- Status last verified
- Dec 2023
- First submitted
- 16 Dec 2021
- Last updated
- 13 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The FEASST Study: Food Intake and Epigenetic Alteration in the Spermatozoa of Singletons and Twins
- ClinicalTrials.gov ID
- NCT05368194
- Acronym / sponsor ID
- FEASST / H-20061598
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- University of CopenhagenUniversity, hospital or other
- Collaborators
- Deakin University, Monash Health
- Study start
- 20 Oct 2021 (actual)
- Primary completion
- 1 Jul 2022 (actual)
- Study completion
- 1 Jul 2022 (actual)
- First posted
- 10 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to elucidate the role of acute dietary intake in male populations, and its impact on spermatozoa quality, integrity, content and epigenetic programming.
Detailed description
The FEASST study has been designed to determine the impact of diet on the content, quality, and genetic programming of sperm. They are specifically interested in determining if a man's diet plays a role in influencing the health of his potential, future offspring through modifications of the sperm. Previous research has highlighted that certain dietary patterns in fathers-to-be may lead to variable health outcome for their children. However, the specific effect of a man's diet has yet to be fully understood. This study will help understand the impact of a man's diet on semen quality and potential downstream implications for child health, to aid in the development of dietary guidelines for future fathers-to-be.
For this study, male participants will be provided with two prescribed diets for three-week increments punctuated by a three month break. Health information and biological samples such as blood, semen, and saliva will be collected from study participants throughout the five month period. The diets will consist of a 'Processed diet', mimicking a traditional Western dietary intake pattern and an 'Unprocessed diet', based upon current dietary guidelines at quantities either adequate for the participants energetic needs or 500 calories in excess per day.
Patient information and samples will be collected before and after each dietary intervention. Aspects of patient health examined at various time points include weight, body fat percentage, sperm quality, epigenetic sequencing, serum levels of metabolic parameters, and survey information surrounding health history, typical diet, physical activity patterns, and treatment adherence.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Isocaloric Arm | Experimental | Dietary Supplement: Isocaloric Unprocessed Diet, Dietary Supplement: Isocaloric Processed DietParticipants within the isocaloric arm will be provided with food provisions in accordance with their nutrition needs. Participants within this arm will be further randomised to the order of first and second dietary interventions for the crossover design; unprocessed diet or processed diet. |
| Excess Calorie Arm | Experimental | Dietary Supplement: Excess Calorie Unprocessed Diet, Dietary Supplement: Excess Calorie Processed DietParticipants within the excess calorie arm will be provided with food provisions in accordance with their nutrition needs plus an additional 500 kilocalories per day. Participants within this arm will be further randomised to the order of first and second dietary interventions for the crossover design; unprocessed diet or processed diet. |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Male
- 20 to 35 years old
- BMI 18.5 to 30
- Located within the Copenhagen region
- Fluent in English and/or Danish language
Key exclusion criteria (13 listed)
- Self-reported history of serious or chronic illness
- Self-reported history of Obesity
- History of any food restrictions
- History of allergies to any food products
- History of disordered eating
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Isocaloric Unprocessed DietIntervention consists of an unprocessed diet meeting the Nordic and Australian Dietary Guidelines for food groups and micronutrients, wherein participants will be supplied with food providing kilocalories (kcal) in accordance with their nutritional needs as calculated based on theSchofield equation based on their weight, activity multiplier, and age at baseline. Almost all food and beverage products provided during this treatment to fall into the category of unprocessed/minimally processed foods and processed culinary ingredients in accordance with the NOVA classification system. | Dietary supplement | Isocaloric Arm |
| Isocaloric Processed DietIntervention consists of a processed diet based on the dietary intake pattern resembling a processed western dietary intake pattern representative of the typical intake pattern of American men aged 19- 50, wherein participants will be supplied with food providing kcals in accordance with their nutritional needs as calculated based on the Schofield equation based on their height, weight, activity multiplier, and age at baseline. Almost all food and beverage products provided during this treatment to fall into the category of processed foods and ultra-processed foods in accordance with the NOVA classification system. | Dietary supplement | Isocaloric Arm |
| Excess Calorie Unprocessed DietIntervention consists of an unprocessed diet meeting the Nordic and Australian Dietary Guidelines for food groups and micronutrients, wherein participants will be supplied with food providing kilocalories (kcal) in accordance with their nutritional needs as calculated based on theSchofield equation based on their weight, activity multiplier, and age at baseline, plus an excess of 500 kcal per day. Almost all food and beverage products provided during this treatment to fall into the category of unprocessed/minimally processed foods and processed culinary ingredients in accordance with the NOVA classification system. | Dietary supplement | Excess Calorie Arm |
| Excess Calorie Processed DietIntervention consists of a processed diet based on the dietary intake pattern resembling a processed western dietary intake pattern representative of the typical intake pattern of American men aged 19- 50, wherein participants will be supplied with food providing kcals in accordance with their nutritional needs as calculated based on the Schofield equation based on their height, weight, activity multiplier, and age at baseline, plus an excess of 500 kcal per day. Almost all food and beverage products provided during this treatment to fall into the category of processed foods and ultra-processed foods in accordance with the NOVA classification system. | Dietary supplement | Excess Calorie Arm |
Primary outcome
Spermatozoa DNA Methylation via Reduced Representation Bisulfite Sequencing
Time frame: 3 weeks
Differential methylation of CpG sites within mature spermatozoa determined from extracted genomic DNA which has undergone library preperation with Ovation® RRBS Methyl-Seq (NuGEN Technologies) and sequenced on a NextSeq Illumina platform.
29 secondary outcomes
Sperm Concentration
Time frame: 3 weeks
Semen Volume
Time frame: 3 weeks
Sperm Motility
Time frame: 3 weeks
Spermatozoa smallRNA expression via sequencing of total smallRNA species
Time frame: 3 weeks
Weight
Time frame: 3 weeks
Body Mass Index (BMI)
Time frame: 3 weeks
Waist Circumference
Time frame: 3 weeks
Hip Circumference
Time frame: 3 weeks
Body Fat Precentage
Time frame: 3 weeks
C-reactive protein (CRP)
Time frame: 3 weeks
Lipoproteins
Time frame: 3 weeks
Total protein
Time frame: 3 weeks
Testosterone
Time frame: 3 weeks
Follicle stimulating hormone (FSH)
Time frame: 3 weeks
Luteinizing hormone (LH)
Time frame: 3 weeks
Progesterone
Time frame: 3 weeks
Estradiol
Time frame: 3 weeks
Oestradiol
Time frame: 3 weeks
Fasting Blood Glucose
Time frame: 3 weeks
Insulin
Time frame: 3 weeks
Haemoglobin A1c (HbA1c)
Time frame: 3 weeks
Blood pressure
Time frame: 3 weeks
Leptin
Time frame: 3 weeks
Glucagon-like peptide 1 (GLP-1)
Time frame: 3 weeks
Gastric inhibitory peptide (GIP)
Time frame: 3 weeks
Glucagon
Time frame: 3 weeks
Ghrelin
Time frame: 3 weeks
Fibroblast growth factor 21 (FGF-21)
Time frame: 3 weeks
Peripheral blood mononuclear cell (PBMC) DNA methylation via Reduced Representation Bisulfite Sequencing
Time frame: 3 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2023.
- Individual participant dataSharing planned: No
Related trials for Fertility Issues
RecruitingObservational study
International Pilot Study for Dual Non-invasive Assesment of Embryo Development
Infertility
Active, not recruitingObservational study
Retrieval of Sperm From Men With Azoospermia Using Ultrasound-guided Rete Testis Aspiration
Azoospermia, Nonobstructive, Infertility, Male
Not yet recruiting
Spinery Basivertebral Nerve Ablation for Vertebrogenic Chronic Low Back Pain
Low Back Pain, Chronic Low Back Pain (CLBP)
RecruitingObservational study
Impact of Infertility on the Sexual Sphere in Couples Undergoing Assisted Reproduction
Sexual Health Quality of Life, Infertile Patients
RecruitingObservational study
Pilot Study of Discarded Blastocysts
Infertility (IVF Patients)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Romain Barrès, PhD principal investigator
University of Copenhagen Novo Nordisk Foundation Center for Basic Metabolic Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Isocaloric Unprocessed Diet, Isocaloric Processed Diet and Excess Calorie Unprocessed Diet in people with Fertility Issues and Nutrition, Healthy, run by University of Copenhagen at 1 site in Denmark.
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 9 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 13 Dec 2023. 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 Denmark. 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. 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?
Spermatozoa DNA Methylation via Reduced Representation Bisulfite Sequencing (time frame: 3 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Dec 2023.