Efficacy and Safety of D-chiro-inositol in Obese Patients

• Sponsor: Lo.Li.Pharma s.r.l (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT05348941
• Collaborator: (none)
• Enrollment: 44
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 5.1
• Patients Per Site Per Month: 8.6

Study Details

Study Description

Brief Summary

The study aims to evaluate the efficacy and tolerability of a food supplement based on D-chiro-inositol in overweight or obese women with insulin resistance, who are approaching a hypocaloric diet

Condition or Disease	Intervention/Treatment	Phase
Insulin Resistance	Dietary Supplement: TECADRIOL	N/A

Detailed Description

Scientific studies on overweight/obese non-diabetic subjects have shown that weight loss improves insulin sensitivity. In fact, in these subjects weight loss reduces the insulin response to the oral glucose load and lowers plasma concentration of triglycerides.

However, although the insulin value is reduced with diet, it does not reach the levels found in overweight/obese non-insulin resistant subjects.

It has been shown that the supplementation of D-chiro-inositol (DCI), a polyol with an insulin-sensitizing action, can positively affect insulin resistance, avoiding the typical side effects of classic insulin sensitizers. In fact, DCI improves glucose tolerance and increases insulin sensitivity, as demonstrated in hyperinsulinemic women with polycystic ovary syndrome.

Therefore, considering the role of DCI, we want to investigate the efficacy and tolerability of a DCI-based product in overweight / obese women with insulin resistance who are approaching a low-calorie diet.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 44 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: Evaluation o Efficacy and Safety of D-chiro-inositol in Insulin Resistant, Obese Patients
• Actual Study Start Date: Jun 28, 2022
• Anticipated Primary Completion Date: Sep 1, 2022
• Anticipated Study Completion Date: Dec 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: Control Hypocaloric balanced diet
Experimental: TECADRIOL Hypocaloric balanced diet plus a food supplement with D-chiro-inositol and alpha-lactalbumin	Dietary Supplement: TECADRIOL; Food supplement containing an association of D-chiro-inositol and alpha-lactalbumin

Outcome Measures

Primary Outcome Measures

1. HOMA index [Three time points: change in HOMA index from the baseline to 2 and 4 months]

   Reduction of HOMA index

Eligibility Criteria

Criteria

• Ages Eligible for Study: 25 Years to 40 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Women between 25 and 40 years old

• Diagnosis of insulin resistance (HOMA ≥2.5)

• 26≤ BMI ≤32

Exclusion Criteria:

• Subjects with no indication for treatment

• Pregnancy and breastfeeding

• Treatment with drugs or supplements that interfere with the mechanism of action of insulin

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Sapienza University of Rome	Roma	RM	Italy	00161

Sponsors and Collaborators

• Lo.Li.Pharma s.r.l

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Lo.Li.Pharma s.r.l
• ClinicalTrials.gov Identifier: NCT05348941
• Other Study ID Numbers: DCI_DIET22
• First Posted: Apr 27, 2022
• Last Update Posted: Jun 30, 2022
• Last Verified: Jun 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Insulin Resistance

Study Results

No Results Posted as of Jun 30, 2022