Does Caralluma fimbriata extract (Slimaluma) combined with Morosil extract reduce the risk factors of metabolic syndrome in overweight and obese adults?

The effect of Caralluma fimbriata extract combined with Morosil extract on the risk factors of metabolic syndrome in overweight and obese adults: a randomised controlled clinical trial

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12613000272796

Enrollment

140

Registered

2013-03-06

Start date

2013-03-12

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

A 16 week intervention using encapsulated Caralluma fimbriata extract and Morosil extract in combination with lifestyle intervention to investigate whether or not Caralluma fimbriata extract and Morosil extract decrease the risk factors of metabolic sydrome

Interventions

Group 1: Placebo group + nutrition advice: Participants will take one 500mg capsule (containing maltodextrin/Placebo) and one 250mg capsule (containing maltodextrin/placebo) orally 30 minutes before meals twice daily for 16 weeks. Participants will also receive nutrition advice in a one on one nutrition consultation with a nutritional therapist for 30-45 minutes, fortnightly for 16 weeks. The recommendations will be based on the Australian Dietary Guidelines for Adults. Group 2: Caralluma fimbriata + nutrition advice group: Participants will take one 500mg capsule (containing Caralluma fimbriata extract) and one 250mg capsule (containing maltodextrin/placebo) orally 30 minutes before meals twice daily for 16 weeks. Participants will also receive nutrition advice in a one on one nutrition consultation with a nutritional therapist for 30-45 minutes, fortnightly for 16 weeks. The recommendations will be based on the Australian Dietary Guidelines for Adults. Group 3: Morosil + nutrition advice group: Participants will take one 500mg capsule (containing Maltodextrin/ Placebo) and one 250mg capsule (containing Morosil extract) orally 30 minutes before meals twice daily for 16 weeks. Participants will also receive nutrition advice in a one on one nutrition consultation with a nutritional therapist for 30-45 minutes, fortnightly for 16 weeks. The recommendations will be based on the Australian Dietary Guidelines for Adults. Group 4: Caralluma fimbriata + Morosil + nutrition advice: Participants will take one 500mg capsule (containing Caralluma fimbriata extract) and one 250mg capsule (containing Morosil) orally 30 minutes before meals twice daily for 16 weeks. Participants will also receive nutrition advice in a one on one nutrition consultation with a nutritional therapist for 30-45 minutes, fortnightly for 16 weeks. The recommendations will be based on the Australian Dietary Guidelines for Adults.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

All

Age

20 Years to 60 Years

Healthy volunteers

Inclusion criteria

Inclusion criteria: Overweight or obese (BMI >25), waist circumference of > 94 cm (male), >80 cm (female), Age: 20-60 years, male or female.

Exclusion criteria

Exclusion criteria: Cigarette smoker, hypertension, all types of heart, Liver and kidney disease, pregnancy, lactating, Type 1 diabetes and weight loss medication.

Outcome results