None listed
Conditions
Interventions
Intervention1: NRG006: Glycyrrhiza glabra extract, Oral Capsule, once daily
Control Intervention1: Placebo: Oral Capsule, once daily
Sponsors
Strider Lifesciences Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Males and females of age of more than equal 18 years and less than equal 50 years. 2. Patients with BMI of 25-30 kg/m2 and HbA1c levels in the prediabetic range 5.7- 6.4 percentage (both included). 3. Participants determined to be in stable health based on medical history, physical examination, and laboratory evaluation at screening. 4. Participants able to undertake a 14 ( 1) hours water-only fast by self-report at visit Day 45. 5. Participants who can and are willing to provide written Informed Consent. 6. Female participant of child-bearing potential must agree to practice a medically acceptable method of birth control during the study period. 7. Participants must agree not to undergo any other type of treatment or procedure for his/her current problem during the study.
Exclusion criteria
Exclusion criteria: 1. Participant with a known history of allergy to any of the ingredients of the nutraceutical regimen or history or presence of multiple severe allergies. 2. Female participant who is pregnant or planning pregnancy during the study period or breastfeeding. 3. Current participation in a weight loss program or use of weight loss medication. 4. Participant undergoing any food restrictions or any condition that may alter body composition within a short period of time; 5. Participant with recent weight loss or gain (5 kg within the last 6 months). 6. Participant with history of significant medical or surgical history within the past 6 months. 7. Participant with diagnosed diseases of the GI tract or previous GI surgery. 8. Participant with history of ischemic gut, diabetes, celiac disease. 9. Participant currently using nonsteroidal anti-inflammatory drugs or glucocorticoid. 10. Participant with history of previous treatment with test products within 4 months. 11. Participant with a history of participation in another clinical study involving another investigational product within 3 months prior to the start of this study or planning participation in another clinical trial during the current study duration. 12. Participant having a mental or physical condition that would, in the opinion of the investigator, place the participant at an unacceptable risk or render the participant unable to meet the requirements of the protocol or interfere with the ability to provide consent or complete study requirements. 13. Participant with a history of Acute or Chronic illness that may compromise immune function or overall health and other severe debilitation conditions like renal insufficiency, hepatic impairment, or any life-threatening conditions. 14. Participant with known medical conditions or medications that may affect the gut or appetite. 15. Evidence of current or recent (within the last 3 months) drug or alcohol abuse or smoking.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the effect of NRG006 compared to placebo on subjective appetite-related parameters by Visual Analog Scale (VAS) in healthy adults.Timepoint: Baseline and week 8 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. To evaluate the effect of NRG006 compared to placebo on craving by Visual Analog Scale (VAS) in healthy adults over a 60-day intervention period. 2. To assess the effect of NRG006 on gut peptide secretion following overnight (8 to 10 hours) fasting. 3. To evaluate the effect of NRG006 on Hba1c, FBS, Fasting Insulin & HOMA-IR. 4. To evaluate the safety & tolerability of the investigational nutraceutical. 5. To evaluate the effect of NRG006 on caloric intake during an ad libitum meal.Timepoint: Baseline, week 2, week 4, week 6 & week8. | — |
Countries
India
Contacts
Public ContactSyed Atif Hussain
Strider Lifesciences Pvt Ltd
Outcome results
None listed