TO EVALUATE THE EFFICACY AND SAFETY OF NMN AS AN ANTI-AGEING SUPPLEMENT IN MIDDLE AGED AND OLDER (40-65 YEARS) ADULTS.

Completed

Conditions: Ageing

Registration Number: CTRI/2021/03/032421

Lead Sponsor: Abinopharm Inc

Brief Summary: Total 80 healthy male or female middle aged or older subjects were assigned in 1:1 ratio to treatment with the test product, AbinoNutraâ„¢ï¸ NMN supplement or Placebo in this Part 1 of double-blind, randomized, placebo-controlled study. 10 Healthy male or female middle aged or older subjects were assigned to the treatment with the test product AbinoNutraâ„¢ï¸ NMN supplement with maximum dose (900 mg) in Part II. All 90 enrolled subjects were instructed to take two to six capsules (dependent on the arms that the subject fall into) of either AbinoNutraâ„¢ï¸ NMN or Placebo once a day after breakfast for 60 days daily. Subjects were required to use diaries to document the date and time of study treatments including any missed doses and the occurrence of any adverse events.

The efficacy in terms of anti-aging effect in part I of the study was assessed primarily with the NAD+NADH concentration in blood, SF-36 questionnaire scoring, 6 Minute Walking Endurance test. HOMA and Biological age by aging.ai 3.0 calculator were explored too to assess AbinoNutraâ„¢ï¸ NMNâ€™s anti-aging effect.

NAD+/NADH concentration in serum was found to be much higher both in Visit 3 (43.14 pmol/ml) and Visit 4 (48.52 pmol/ml) in the 300 mg NMN supplement arm as compared to the Placebo (11.77 pmol/ml). The mean treatment difference for NAD+/NADH concentration in serum was found to be statistically significant at 5% level of significance in Visit 3 as well as in Visit 4 (p-values 0.0004 and 0.0001 respectively).

Similar results were obtained for the 600 mg NMN supplement arm as compared to the Placebo and 900 mg NMN supplement arm as compared to the Placebo. The mean treatment difference for NAD+/NADH concentration in serum was found to be statistically significant at 5% level of significance in Visit 3 as well as in Visit 4 (all p-values were less than 0.0001).

This illustrates the potential of AbinoNutraâ„¢ï¸ NMN to raise the levels of NAD+ in the cells.

From the data it was observed that the walking endurance (distance walked) of the subjects on the active i.e. AbinoNutraâ„¢ï¸ NMN group had a significant rise at the end of the study.

There was a rise of 12.80 m., 18.71 m., 18.40 m. respectively in 300 mg, 600 mg and 900 mg AbinoNutraâ„¢ï¸ NMN as compared to a rise of 6.67 m. in placebo group in 2 months in distance (meters) walked in 6 minutes.

There was a noteworthy rise in the SF 36 score seen in the AbinoNutraâ„¢ï¸ NMN group which meant that the well-being of the subjects was increased by consuming AbinoNutraâ„¢ï¸ NMN for 60 days.

There was a statistically significant difference between the 300 mg AbinoNutraâ„¢ï¸ NMN supplement arm as compared to Placebo in Visit 4 for biological age values. Similar results were observed for the 600 mg and the 900 mg arms.

The analysis showed that there was no noteworthy change in HOMA score in the AbinoNutraâ„¢ï¸ NMN group although there was a noteworthy rise in the placebo group by the end of study from the baseline. We can correlate these results with anti-aging effect of AbinoNutraâ„¢ï¸ NMN as in the absence of AbinoNutraâ„¢ï¸ NMN the parameter (HOMA IR Index) worsened. Also, the study population consisted of healthy volunteers and not diabetics or pre-diabetic population, where HOMA IR Index results could have been different.

In Part II, Telomere length was quantified for each subject and comparison from baseline to end of study was done for each subject individually.

The telomere length was seen to be increased for 3 subjects at 900 mg dose. In other 4 subjects the reduction in telomere length was not much from the baseline value at the start of the trial. Considering the short duration of treatment of 60 days, the results seem promising for the potential of AbinoNutraâ„¢ï¸ NMN in its anti-ageing effect assessed by telomere length quantification.

For safety analysis, after the unblinding, during analysis, it was revealed that there were only 4 cases of AEs reported in AbinoNutraâ„¢ï¸ NMN 300 mg arm, which were determined to be not related to 300 mg AbinoNutraâ„¢ï¸ NMN by investigators. There were no AEs reported in 600 mg and 900 mg AbinoNutraâ„¢ï¸ NMN arms in Part I, as well as in subjects included part II of the study, on 900 mg AbinoNutraâ„¢ï¸ NMN dose.

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 90

Inclusion Criteria

Male/females of 40 to 65 years of age 2.
Body Mass Index (BMI) between 18.5 and 35 kg/m2 3.
Able to provide written Informed Consent 4.
Able to follow verbal and written study directions 5.
Must not be taking or be willing to take any supplements containing any form of niacin for seven days prior to baseline and for the duration of the study.
Able to maintain consistent diet and lifestyle habits throughout the study 7.
Male and female subjects must be willing to agree to use effective contraceptive methods while on treatment and for 3 months after the completion of study 8.
Willing to consume assigned dietary supplements for 2 months.

Exclusion Criteria

Participants on current use of prescription or over-the-counter nicotinic acid 2.
Use of statin drugs 3.
Having used any tobacco product or used a recreational drug in the past 6 months 4.
Having abnormal screening laboratory test values or other lab test result(s) that would preclude study participation in the judgment of the investigator 5.
History of drug or alcohol abuse 7.
History of unstable depression or mental illness within the last 6 months for which the investigator believes could impact the participantâ€™s ability to comply with study requirements 8.
Unwilling to discontinue use of conventional multivitamin/mineral or other supplements at least two weeks prior to the study start 9.
Participating in or planning to begin a weight loss diet during the study period 10.
Lifestyle or schedule incompatible with the study protocol 11.
Known hypersensitivity to the drug components used during the study 12.
Women with positive result for urinary beta human chorionic gonadotropin or gestation period or breastfeeding 13.
Other diseases or medications, according to the investigator, that would interfere directly in the results of the study or jeopardize the health of the participant.
Currently, or within the past 30 days, enrolled in a different clinical investigation 15.
Inability to provide a venous blood sample 16.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Part I	To compare the results of telomere test with NMN [Time Frame: 2 Months]. ï‚· To compare the efficacy of NMN as anti-ageing supplementation [Time Frame: 2 Months].
To compare the efficacy of NMN as anti-ageing supplementation versus placebo [Time Frame: 2 Months].	To compare the results of telomere test with NMN [Time Frame: 2 Months]. ï‚· To compare the efficacy of NMN as anti-ageing supplementation [Time Frame: 2 Months].
To compare the results of telomere test with NMN [Time Frame: 2 Months]. ï‚· To compare the efficacy of NMN as anti-ageing supplementation [Time Frame: 2 Months].	To compare the results of telomere test with NMN [Time Frame: 2 Months]. ï‚· To compare the efficacy of NMN as anti-ageing supplementation [Time Frame: 2 Months].

Secondary Outcome Measures

Name	Time	Method
To compare the safety and tolerability of the NMN supplementation versus placebo [ Time Frame: 2 Months] (Incidence and type of adverse events)	To assess the safety and tolerability of the NMN supplementation

Trial Locations

Locations (2): Sunad Ayurved Clinic
🇮🇳
Pune, MAHARASHTRA, India
SWASTHYA CLINIC & RESEARCH CENTRE
🇮🇳
Pune, MAHARASHTRA, India
Sunad Ayurved Clinic
🇮🇳Pune, MAHARASHTRA, India
Dr Vidyadhar Kumbhar
Principal investigator
9960075536
dr.vidyadhar24@gmail.com