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Resistant Starch, Epigallocatechin Gallate and Chlorogenic Acid for Body Weight Loss in Menopause

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ClinicalTrials.gov Identifier: NCT02887950
Recruitment Status : Recruiting
First Posted : September 2, 2016
Last Update Posted : February 26, 2019
Sponsor:
Collaborator:
Leonardo Medica Srl
Information provided by (Responsible Party):
Riccardo Caccialanza, IRCCS Policlinico S. Matteo

Brief Summary:

For women aged between 55 and 65 years weight gain is a major health concern. Obesity is an important risk factor for multiple diseases (e.g. metabolic syndrome, diabetes mellitus, hypertension and cardiovascular disease), and several studies have shown that the transition to menopause is associated with adverse changes in body composition. In particular, it is common to observe the accumulation of adipose tissue in the abdominal region which is believed to be an important determinant of the increase in cardiovascular risk.

The first-line strategy for weight management in overweight / obese subjects is the modification of dietary habits and lifestyle in terms of physical activity. However, nowadays, there is also a growing interest in complementary therapies (i.e. herbal supplements, acupuncture, etc ...) that can be used alone or in combination to achieve more consistent results. In this context, preliminary evidence supports the potential role of some compounds of vegetal origin such as resistant starch, epigallocatechin gallate and chlorogenic acid as adjuvants of dietary therapy for overweight.

These nutrients may be an important therapeutic aid for overweight subjects. However, in support of their use, the evidence from good quality trials is limited.


Condition or disease Intervention/treatment Phase
Overweight Other: Nutritional counseling Dietary Supplement: Equikilon-3 months Dietary Supplement: Equikilon-6 months Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 144 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Resistant Starch, Epigallocatechin Gallate and Chlorogenic Acid for Body Weight Loss in Overweight Menopausal Women: a Pragmatic, Randomised Clinical Trial.
Actual Study Start Date : September 2016
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : September 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Nutritional counseling
Nutritional counseling consists in: personalized dietary prescription associated with dietetic advise (on a monthly basis and upon patient's request) by a registered dietician.
Other: Nutritional counseling
Nutritional counseling consists in: personalized dietary prescription associated with dietetic advise (on a monthly basis and upon patient's request) by a registered dietician.

Experimental: Equikilon-3 months

The patient will receive 2 sachets per day of a dietary supplement containing resistant starch, epigallocatechin gallate and chlorogenic acid (Equikilon) for 3 months and nutritional counseling.

Nutritional counseling consists in: personalized dietary prescription associated with dietetic advise (on a monthly basis and upon patient's request) by a registered dietician.

Dietary Supplement: Equikilon-3 months

The patient will receive 2 sachets per day of a dietary supplement containing resistant starch, epigallocatechin gallate and chlorogenic acid (Equikilon) for 3 months and nutritional counseling.

Nutritional counseling consists in: personalized dietary prescription associated with dietetic advise (on a monthly basis and upon patient's request) by a registered dietician.


Experimental: Equikilon-6 months

The patient will receive 2 sachets per day of a dietary supplement containing resistant starch, epigallocatechin gallate and chlorogenic acid (Equikilon) for 6 months and nutritional counseling.

Nutritional counseling consists in: personalized dietary prescription associated with dietetic advise (on a monthly basis and upon patient's request) by a registered dietician.

Dietary Supplement: Equikilon-6 months

The patient will receive 2 sachets per day of a dietary supplement containing resistant starch, epigallocatechin gallate and chlorogenic acid (Equikilon) for 6 months and nutritional counseling.

Nutritional counseling consists in: personalized dietary prescription associated with dietetic advise (on a monthly basis and upon patient's request) by a registered dietician.





Primary Outcome Measures :
  1. Body weight [ Time Frame: 3 months ]
    Difference in change in body weight between patients receiving the experimental product and those not assigned to its use


Secondary Outcome Measures :
  1. Body weight [ Time Frame: 6 months ]
    Difference in change in body weight between patients receiving the experimental product for 6 months and those assigned to its use for 3 months

  2. Insulin resistance [ Time Frame: 3 months ]
    Difference in change in homeostasis model assessment of insulin resistance between patients receiving the experimental product and those not assigned to its use

  3. LDL cholesterol [ Time Frame: 3 months ]
    Difference in change in LDL cholesterol between patients receiving the experimental product and those not assigned to its use

  4. Triglycerides [ Time Frame: 3 months ]
    Difference in change in triglycerides between patients receiving the experimental product and those not assigned to its use

  5. Insulin resistance [ Time Frame: 6 months ]
    Difference in change in homeostasis model assessment of insulin resistance between patients receiving the experimental product for 6 months and those assigned to its use for 3 months

  6. LDL cholesterol [ Time Frame: 6 months ]
    Difference in change in LDL cholesterol between patients receiving the experimental product for 6 months and those assigned to its use for 3 months

  7. Triglycerides [ Time Frame: 6 months ]
    Difference in change in triglycerides between patients receiving the experimental product for 6 months and those assigned to its use for 3 months

  8. Visceral adiposity [ Time Frame: 3 months ]
    Difference in change in anthropometric parameters describing fat distribution (waist circumference) between patients receiving the experimental product and those not assigned to its use

  9. Visceral adiposity [ Time Frame: 6 months ]
    Difference in change in anthropometric parameters describing fat distribution (waist circumference) between patients receiving the experimental product for 6 months and those assigned to its use for 3 months

  10. Fat free mass [ Time Frame: 3 months ]
    Difference in change in body composition parameters (measured by bioelectrical impedance analysis) between patients receiving the experimental product and those not assigned to its use

  11. Fat free mass [ Time Frame: 6 months ]
    Difference in change in body composition parameters (measured by bioelectrical impedance analysis) between patients receiving the experimental product for 6 months and those assigned to its use for 3 months

  12. Menopausal symptoms [ Time Frame: 3 months ]
    Difference in change in the severity of menopausal symptoms (using the Green Climacteric Scale) between patients receiving the experimental product and those not assigned to its use

  13. Menopausal symptoms [ Time Frame: 6 months ]
    Difference in change in the severity of menopausal symptoms (using the Green Climacteric Scale) between patients receiving the experimental product for 6 months and those assigned to its use for 3 months

  14. Quality of life [ Time Frame: 3 months ]
    Difference in change in quality of life (measured by the SF-36 Health Survey) between patients receiving the experimental product and those not assigned to its use

  15. Quality of life [ Time Frame: 6 months ]
    Difference in change in quality of life (measured by the SF-36 Health Survey) between patients receiving the experimental product for 6 months and those assigned to its use for 3 months



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • menopause of recent onset
  • overweight (body mass index ≥ 25) or weight gain ≥ 10% after menopause
  • written informed consent

Exclusion Criteria:

  • use of Orlistat
  • cancer diagnosis
  • unavailability to planned measurements

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02887950


Contacts
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Contact: Riccardo Caccialanza, MD 00390382501615 r.caccialanza@smatteo.pv.it

Locations
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Italy
Fondazione IRCCS Policlinico San Matteo Recruiting
Pavia, Italy, 27100
Contact: Riccardo Caccialanza, MD         
Sub-Investigator: Emanuele Cereda, MD, PhD         
Sub-Investigator: Rossella Elena Nappi, MD         
Sponsors and Collaborators
IRCCS Policlinico S. Matteo
Leonardo Medica Srl
Investigators
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Principal Investigator: Riccardo Caccialanza, MD Fondazione IRCCS Policlinico San Matteo

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Responsible Party: Riccardo Caccialanza, Principal Investigator, IRCCS Policlinico S. Matteo
ClinicalTrials.gov Identifier: NCT02887950     History of Changes
Other Study ID Numbers: 20150021742
First Posted: September 2, 2016    Key Record Dates
Last Update Posted: February 26, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
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Epigallocatechin gallate
Overweight
Weight Loss
Body Weight
Signs and Symptoms
Body Weight Changes
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Antimutagenic Agents
Anticarcinogenic Agents
Antineoplastic Agents
Neuroprotective Agents