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The purpose of this study is to determine the physiological effects of weight loss on seminal parameters in male participants with reduced reproductive capacity. Learning more about the physiological role of weight loss on reproductive function and metabolic profile of overweight and obese men may give us a better understanding of male fertility and improve the management of patients with reduced fertility. The effects of weight loss on seminal quality are not well understood.
Participants will receive dietary supplements or National Health Service (NHS) advice on healthy eating to achieve weight loss.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low Energy Diet | Other | Commercially available diet products |
|
| NHS advice on healthy eating | Other | Dietary / lifestyle advice programme |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Low Energy Diet | Dietary Supplement | Caloric restriction to achieve weight loss |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Sperm Concentration | The number of sperm per millimeter of semen. Sperm concentration is an important factor affecting male fertility. It is calculated on a standard semen analysis | 16 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Total Motility | Total motility refers to the percentage of sperm making any sort of movement. | 16 weeks |
| Progressive Motility | This type of motility refers to sperm that swim progressively, mostly in a straight line or large circles. |
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Inclusion Criteria:
Exclusion Criteria:
Alcohol intake >30 units per week Smoking daily Recreational drug use at a frequency not less than weekly
male
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| Name | Affiliation | Role |
|---|---|---|
| Channa Jayasena, MD PhD | Imperial College London | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Imperial College NHS Healthcare Trust | North West London | W12 0HS | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23242914 | Background | Sermondade N, Faure C, Fezeu L, Shayeb AG, Bonde JP, Jensen TK, Van Wely M, Cao J, Martini AC, Eskandar M, Chavarro JE, Koloszar S, Twigt JM, Ramlau-Hansen CH, Borges E Jr, Lotti F, Steegers-Theunissen RP, Zorn B, Polotsky AJ, La Vignera S, Eskenazi B, Tremellen K, Magnusdottir EV, Fejes I, Hercberg S, Levy R, Czernichow S. BMI in relation to sperm count: an updated systematic review and collaborative meta-analysis. Hum Reprod Update. 2013 May-Jun;19(3):221-31. doi: 10.1093/humupd/dms050. Epub 2012 Dec 12. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Low Energy Diet | Commercially available diet products Low Energy Diet: Caloric restriction to achieve weight loss |
| FG001 | NHS Advice on Healthy Eating | Dietary / lifestyle advice programme NHS advice on healthy eating: Advice on energy requirements as per the British Dietetic Association |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Study A (Men With a Normal Sperm Conc.) |
|
| ||||||||||||||||||
| Study B (Men With a Low Sperm Conc.) |
|
The overall number of baseline participants refers to the total number after combining the two sub-studies
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| ID | Title | Description |
|---|---|---|
| BG000 | Low Energy Diet | Commercially available diet products Low Energy Diet: Caloric restriction to achieve weight loss |
| BG001 | NHS Advice on Healthy Eating | Dietary / lifestyle advice programme NHS advice on healthy eating: Advice on energy requirements as per the British Dietetic Association |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | The overall number of baseline participants refers to the total number after combining the two sub-studies |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Sperm Concentration | The number of sperm per millimeter of semen. Sperm concentration is an important factor affecting male fertility. It is calculated on a standard semen analysis | The overall number of participants analyzed refers to the total number after combining the two sub-studies | Posted | Mean | Standard Deviation | million sperms/mL | 16 weeks |
|
16 weeks
Adverse events were monitored for as defined as per clinicaltrials.gov definitions.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Low Energy Diet | Commercially available diet products Low Energy Diet: Caloric restriction to achieve weight loss |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Channa Jayasena | Imperial College London | 02083833242 | c.jayasena@imperial.ac.uk |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 9, 2020 | Jan 8, 2021 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jan 14, 2020 | Jan 8, 2021 | ICF_002.pdf |
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| ID | Term |
|---|---|
| D007248 | Infertility, Male |
| D009765 | Obesity |
| D015431 | Weight Loss |
| ID | Term |
|---|---|
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007246 | Infertility |
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| ID | Term |
|---|---|
| D031204 | Caloric Restriction |
| ID | Term |
|---|---|
| D004035 | Diet Therapy |
| D044623 | Nutrition Therapy |
| D013812 | Therapeutics |
| D002149 | Energy Intake |
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2 sub-studies Study A (men with a normal sperm concentration) Study B (men with a low sperm concentration)
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| NHS advice on healthy eating |
| Other |
Advice on energy requirements as per the British Dietetic Association |
|
| 16 weeks |
| DNA Fragmentation Index (DFI) | Percentage of sperm with fragmented DNA | 16 weeks |
| Testosterone | Testosterone is the primary androgen in men and is synthesized in the testes. It can be measured in the serum. | 16 weeks |
| Sex Hormone-Binding Globulin (SHBG) | SHBG is a protein that is produced by the liver and binds tightly to the hormones testosterone, dihydrotestosterone (DHT) and oestradiol, and transports them in the blood in an inactive form. | 16 weeks |
| Reactive Oxygen Species (ROS) | ROS is measured by oxidative colour change of luminol per second per million sperm. | 16 weeks |
| Morphology | the percentage of sperm that appear normal when semen is viewed under a microscope | 16 weeks |
| Luteinizing Hormone (LH) | LH produced in the pituitary gland, stimulates the leydig cells in the testes to produce testosterone. | 16 weeks |
| Follicle Stimulating Hormone (FSH) | FSH produced in the pituitary gland, stimulates the testes to produce mature sperm. | 16 weeks |
| NOT COMPLETED |
|
|
| BG002 | Total | Total of all reporting groups |
| Count of Participants |
| Participants |
|
| Age, Continuous | The overall number of baseline participants refers to the total number after combining the two sub-studies | Mean | Standard Deviation | Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Weight | The overall number of baseline participants refers to the total number after combining the two sub-studies | Mean | Standard Deviation | Kilograms |
|
| Waist circumference | The overall number of baseline participants refers to the total number after combining the two sub-studies | Mean | Standard Deviation | Centimetres |
|
| Sperm concentration | The overall number of baseline participants refers to the total number after combining the two sub-studies | Mean | Standard Deviation | million sperms/mL |
|
| Semen volume | The overall number of baseline participants refers to the total number after combining the two sub-studies | Mean | Standard Deviation | ml |
|
| Progressive motility | This type of motility refers to sperm that swim progressively, mostly in a straight line or large circles | The overall number of baseline participants refers to the total number after combining the two sub-studies. Some participants in Study B were not assessed for this measure due to sperm concentrations that were too low to measure progressive motility. | Mean | Standard Deviation | percentage of progressively motile sperm |
|
| Total motility | Total motility refers to the percentage of sperm making any sort of movement. | The overall number of baseline participants refers to the total number after combining the two sub-studies. Some participants in Study B were not assessed for this measure due to sperm concentrations that were too low to measure total motility. | Mean | Standard Deviation | percentage of sperm that is motile |
|
| Body Mass Index (BMI) | The overall number of baseline participants refers to the total number after combining the two sub-studies | Mean | Standard Deviation | kg/m^2 |
|
| DNA Fragmentation Index | Percentage of sperm with fragmented DNA | The overall number of baseline participants refers to the total number after combining the two sub-studies Some participants in Study B were not assessed for this measure due to sperm concentrations that were too low to measure DNA Fragmentation Index.. | Mean | Standard Deviation | percentage of sperm with fragmented DNA |
|
| Testosterone | The overall number of baseline participants refers to the total number after combining the two sub-studies | Mean | Standard Deviation | nmol/l |
|
| Sex hormone-binding globulin (SHBG) | The overall number of baseline participants refers to the total number after combining the two sub-studies | Mean | Standard Deviation | nmol/l |
|
| Reactive oxygen species (ROS) | ROS is measured by oxidative colour change of luminol per second per million sperm | ROS was only measured in Study B. Some participants in Study B were not assessed for this measure due to sperm concentrations that were too low to measure ROS. . | Median | Inter-Quartile Range | RLU/sec/million sperm |
|
| Morphology | the percentage (%) of sperm that appear normal when semen is viewed under a microscope. | Some participants in Study B were not assessed for this measure due to sperm concentrations that were too low to analyze morphology. | Mean | Standard Deviation | percentage of sperm of normal morphology |
|
| Luteinizing Hormone (LH) | The overall number of baseline participants refers to the total number after combining the two sub-studies | Mean | Standard Deviation | IU/l |
|
| Follicle Stimulating Hormone (FSH) | The overall number of baseline participants refers to the total number after combining the two sub-studies | Mean | Standard Deviation | IU/l |
|
|
|
| Secondary | Total Motility | Total motility refers to the percentage of sperm making any sort of movement. | The overall number of participants analyzed refers to the total number after combining the two sub-studies. Some participants in Study B were not assessed for this measure due to sperm concentrations that were too low to measure total motility. | Posted | Mean | Standard Deviation | percentage of sperm that is motile | 16 weeks |
|
|
|
| Secondary | Progressive Motility | This type of motility refers to sperm that swim progressively, mostly in a straight line or large circles. | The overall number of participants analyzed refers to the total number after combining the two sub-studies. Some participants in Study B were not assessed for this measure due to sperm concentrations that were too low to measure progressive motility. | Posted | Mean | Standard Deviation | percentage of progressively motile sperm | 16 weeks |
|
|
|
| Secondary | DNA Fragmentation Index (DFI) | Percentage of sperm with fragmented DNA | The overall number of participants analyzed refers to the total number after combining the two sub-studies. Some participants in Study B were not assessed for this measure due to sperm concentrations that were too low to measure DNA fragmentation index. | Posted | Mean | Standard Deviation | Percentage of sperm with fragmented DNA | 16 weeks |
|
|
|
| Secondary | Testosterone | Testosterone is the primary androgen in men and is synthesized in the testes. It can be measured in the serum. | The overall number of participants analyzed refers to the total number after combining the two sub-studies. One participant in Low Energy Diet arm in study B did not have this measurement due to insufficient sample. | Posted | Mean | Standard Deviation | nmol/l | 16 weeks |
|
|
|
| Secondary | Sex Hormone-Binding Globulin (SHBG) | SHBG is a protein that is produced by the liver and binds tightly to the hormones testosterone, dihydrotestosterone (DHT) and oestradiol, and transports them in the blood in an inactive form. | The overall number of participants analyzed refers to the total number after combining the two sub-studies. One participant in Low Energy Diet arm in study B did not have this measurement due to insufficient sample. | Posted | Mean | Standard Deviation | nmol/l | 16 weeks |
|
|
|
| Secondary | Reactive Oxygen Species (ROS) | ROS is measured by oxidative colour change of luminol per second per million sperm. | ROS was only measured in Study B. Some participants in Study B were not assessed for this measure due to sperm concentrations that were too low to measure ROS. | Posted | Median | Inter-Quartile Range | RLU/sec/million sperm | 16 weeks |
|
|
|
| Secondary | Morphology | the percentage of sperm that appear normal when semen is viewed under a microscope | The overall number of participants analyzed refers to the total number after combining the two sub-studies. Some participants in Study B were not assessed for this measure due to sperm concentrations that were too low to measure morphology. | Posted | Mean | Standard Deviation | percentage of sperm of normal morphology | 16 weeks |
|
|
|
| Secondary | Luteinizing Hormone (LH) | LH produced in the pituitary gland, stimulates the leydig cells in the testes to produce testosterone. | The overall number of participants analyzed refers to the total number after combining the two sub-studies. One participant in Low Energy Diet arm in study B did not have this measurement due to insufficient sample. | Posted | Mean | Standard Deviation | IU/l | 16 weeks |
|
|
|
| Secondary | Follicle Stimulating Hormone (FSH) | FSH produced in the pituitary gland, stimulates the testes to produce mature sperm. | The overall number of participants analyzed refers to the total number after combining the two sub-studies. One participant in Low Energy Diet arm in study B did not have this measurement due to insufficient sample. | Posted | Mean | Standard Deviation | IU/l | 16 weeks |
|
|
|
| 0 |
| 36 |
| 0 |
| 36 |
| 0 |
| 36 |
| EG001 | NHS Advice on Healthy Eating | Dietary / lifestyle advice programme NHS advice on healthy eating: Advice on energy requirements as per the British Dietetic Association | 0 | 37 | 0 | 37 | 0 | 37 |
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| D052801 |
| Male Urogenital Diseases |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001836 | Body Weight Changes |
| D004032 |
| Diet |
| D009747 | Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| Between 18 and 65 years |
|
| >=65 years |
|
| men with a low sperm concentration |
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| study B (men with a low sperm concentration) |
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| study B (men with a low sperm concentration) |
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| study B (men with a low sperm concentration) |
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| study B (men with a low sperm concentration) |
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| Study B (men with a low sperm concentration) |
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| Study B (men with a low sperm concentration) |
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| Study B (men with a low sperm concentration) |
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