Nicotinamide Riboside and Mitochondrial Metabolism
Raktažodžiai
Santrauka
Datos
| Paskutinį kartą patikrinta: | 11/30/2019 |
| Pirmasis pateikimas: | 01/09/2019 |
| Numatytas registravimas pateiktas: | 05/12/2019 |
| Pirmas paskelbtas: | 05/14/2019 |
| Paskutinis atnaujinimas pateiktas: | 12/22/2019 |
| Paskutinis atnaujinimas paskelbtas: | 12/23/2019 |
| Faktinė studijų pradžios data: | 05/24/2016 |
| Numatoma pirminio užbaigimo data: | 05/30/2019 |
| Numatoma studijų užbaigimo data: | 05/30/2019 |
Būklė ar liga
Intervencija / gydymas
Dietary Supplement: NR
Dietary Supplement: NR in BMI-concordant twins
Fazė
Rankų grupės
| Ranka | Intervencija / gydymas |
|---|---|
| Experimental: NR One intervention includes healthy BMI-discordant monozygotic twin pairs, which both are treated with NR. With this unique model, the investigators obtain the information on how beneficial NR is in two different BMI classes (obese and leaner) with an identical genomic background.
The final dose for NR will be 1 g/day. The daily NR dose is gradually escalated by 250 mg/week so that the full dose of 1 g/day is reached in one month. The intervention time with the full NR dose is 4 months, total intervention time 5 months. At the end of the study, the daily dose will be decreased by 250 mg/week rate. | Dietary Supplement: NR Water-soluble form of vitamin B3, nicotinamide riboside (NR) is used in this study. The NR product name is Niagen, produced by ChromaDex. NR does not cause the known side effects (vasodilation and flushing) of another vitamin B3, niacin. |
| Placebo Comparator: Placebo The second intervention includes monozygotic twins concordant for body weight. It's randomized which member of the twin pair is treated with NR while the other co-twin gets placebo.
The final dose for placebo will be 1 g/day. The daily placebo dose is gradually escalated by 250 mg/week so that the full dose of 1 g/day is reached in one month. The intervention time with the full placebo dose is 4 months, total intervention time 5 months. At the end of the study, the daily dose will be decreased by 250 mg/week rate. |
Tinkamumo kriterijai
| Amžius, tinkami studijuoti | 18 Years Į 18 Years |
| Tinkamos studijoms lytys | All |
| Priima sveikus savanorius | Taip |
| Kriterijai | Inclusion Criteria: 1. BMI >18.5 kg/m2 in both members of the twin pair 2. Agreed to maintain current level of physical activity throughout the study 3. Agreed to avoid vitamin supplementation or nutritional products with vitamin B3 14 days prior to the enrolment and during the study 4. Written, informed consent to participate in the study Exclusion Criteria: 1. Unstable medical conditions as determined by the principal investigator 2. Clinically significant abnormal lab results at screening (e.g. AST and/or ALT > 2 x ULN, and/or bilirubin > 2 x ULN) 3. Subjects who have a planned surgery during the course of the trial 4. History of or a current diagnosis of any cancer (except for successfully treated basal cell carcinoma diagnosed less than 5 years prior to screening). Subjects with cancer in full remission more than 5 years after diagnosis are acceptable. 5. History of blood/bleeding disorders 6. Immunocompromised individuals such as subjects that had undergone organ transplantation or subjects diagnosed with human immunodeficiency virus (HIV) 7. Hepatitis 8. Blood donation in the previous 2 months 9. Anemia (hemoglobin <120) 10. Participation in a clinical research trial within 30 days prior to randomization 11. Allergy or sensitivity to study supplement ingredients 12. Individuals who are cognitively impaired and/or who are unable to give informed consent. 13. Any other condition, which in the principal investigator's opinion may adversely affect the subject's ability to complete the study or its measures or which may have posed significant risk to the subject. |
Rezultatas
Pirminės rezultatų priemonės
1. Mitochondrial biogenesis - mitochondrial DNA quantification [At baseline and 5 months after supplementation]
2. Mitochondrial biogenesis - mitochondria-related mRNA expression [At baseline and 5 months after supplementation]
3. Mitochondrial biogenesis - electron microscopy [At baseline and 5 months after supplementation]
Antrinės rezultatų priemonės
1. NAD+ and related metabolite levels in blood [At baseline and 5 months after supplementation]
2. Skeletal muscle mitochondrial oxidative capacity [At baseline and 5 months after supplementation]
Kitos rezultato priemonės
1. Body weight and body composition [At baseline and 5 months after supplementation]
2. Ectopic lipid accumulation in liver and muscle (in vivo) [At baseline and 5 months after supplementation]
3. Whole body insulin sensitivity [At baseline and 5 months after supplementation]
4. Circulating inflammation markers [At baseline and 5 months after supplementation]
