Freeze-dried Kale to Reduce Metabolic Risk in Saudi Subjects

Obesity Clinical Trial

Official title:

Acute and Medium Effects of Freeze-dried Kale to go, New Superfood Supplement to Reduce Metabolic Risk in Saudi Subjects

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04904601
• Other study ID #: 20121503
• Status: Recruiting
• Phase: N/A
• Start date: September 15, 2021
• Est. completion date: December 27, 2022

Study information

• Verified date: January 2022
• Source: Chair for Biomarkers of Chronic Diseases
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Whilst obesity represents a key risk factor for the development of metabolic disease and further premature mortality, the actual type of diet may provide the 'primary insults' for inflammation affecting systemic health in the pre-diabetic state such as obesity. Specifically, previous data indicate that a high-fat diet and/or unfavorable systemic lipid profiles can impair metabolic health which may occur via inflammatory mechanisms. The study aims to conduct a randomized interventional dietary trial with Freeze-dried Kale, as a superfood, to reduce inflammation and improve lipid profile in patients with obesity. These studies will analyze the effects of this superfood on metabolic changes among obese and non-obese Saudi women. Our hypothesis is the inclusion of Brassica into the daily diet will significantly improve metabolic health, microbiota composition, lower inflammatory insults (inflammasome), and lower microbial translocation, with resulting improvements in metabolic health. The team, therefore, proposes to examine the impact of the superfood kale on lipid function (acute and medium-term) over a 4 week dietary intervention period to assess the influence on metabolic change and biomarker changes. The team intends to utilize the expertise from a broad spectrum of specialists from plant biologists, clinical and allied health care professionals, and translational scientists, to provide a unique holistic insight into the role of nutrition for metabolic health benefits in human participants. These studies will provide us with the capacity to use a directly applicable dietary supplement, freeze-dried Kale, to improve the health of people metabolically. As this is a natural product, this will have the capability to reach the market much quicker and advance research at a much faster pace. This dietary supplement will also provide an additional measure to improve the health across the general public not just those at increased risk of disease to help provide another way to improve health among Saudis.

Description:

Subjects Selection:

For this study we will recruit a total of 100 obese age matched non-diabetic Saudi women, (age 18-40 years; BMI 30-40Kg/m2) through college clinics in applied medical sciences college, KSU. The study participants exclusion criteria in brief: age under 18 or above 40 years, any medical/endocrine problem that could affect energy expenditure (e.g. thyroid problems, Cushing's syndrome); chronic inflammatory disorders like rheumatoid arthritis, or long term use of steroids or other immunomodulatory like cyclosporine, azathioprine; severe depression or any psychiatric illness, claustrophobia or needle phobia.

Sample and Data Collections:

Anthropometry and body composition as well as biochemical data will be undertaken for all visits, including blood, urine and stool collection. Serum will be collected all patients for later analysis. All samples collected will be stored appropriately for biochemical analysis within the Bio-Bank facilities, in the Chair for Biomarkers of Chronic Diseases in King Saud University. All samples will be stored at -80oC following the appropriate protocol extraction methods.

Intervention:

Participants will be randomized to give either Kale (blanched freeze dried Kale) group1 or placebo (Blanched Freeze dried Peas) group2. The supplements will be given as one scoop of powder of (Kale or Green Peas) three times a day for a total of 10g/day. The follow up will be for 6 week intervention. After visit 2 will be washout period for 2 weeks, to study acute and medium effects, followed by a cross-over between the groups.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 27, 2022
• Est. primary completion date: February 26, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

• Obese (BMI 30-40Kg/m2 and above)

• Aged 18-40 years

• Saudi nationality

• Female

Exclusion Criteria:

• Age under 18 or above 40 years

• Any medical/endocrine problem that could affect energy expenditure (e.g. thyroid problems, Cushing's syndrome)

• Those with chronic inflammatory disorders like rheumatoid arthritis, or long term use of steroids or other immunomodulatory like cyclosporine, azathioprine; severe depression or any psychiatric illness, claustrophobia or needle phobia.

• Males

• Expatriates

Related Conditions & MeSH terms

• Metabolic Disease
• Metabolic Diseases
• Obesity

Intervention

Dietary Supplement:
• Kale supplement
Kale (blanched freeze-dried Kale) group1
• Peas supplement
placebo (Blanched Freeze-dried Peas) group2

Locations

Country	Name	City	State
Saudi Arabia	Community Health Department, Applied Medical Sciences, King Saud University	Riyadh

Sponsors (2)

Lead Sponsor	Collaborator
Chair for Biomarkers of Chronic Diseases	King AbdulAziz City for Science and Technology

Country where clinical trial is conducted

Saudi Arabia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Study the acute-term effects of freeze-dried Kale in lipid profile of obese, non-T2DM women	Differences in characteristics of total cholesterol (mmol/l), hdl-cholesterol (mmol/l), ldl-cholesterol (mmol/l) and triglycerides (mmol/l) at baseline and subsequent follow ups.	2 weeks
Primary	Study the medium-term effects of freeze-dried Kale in lipid profile of obese, non-T2DM women	Differences in characteristics of total cholesterol (mmol/l), hdl-cholesterol (mmol/l), ldl-cholesterol (mmol/l) and triglycerides (mmol/l) at baseline and subsequent follow ups.	4 weeks
Secondary	Study the acute and medium term effects of Kale Superfood on BMI	Differences in body mass index (BMI, kg/m2) at baseline and subsequent follow-ups	6 weeks
Secondary	Study the acute and medium term effects of Kale Superfood on glucose levels	Differences in fasting glucose (mmol/l), at baseline and subsequent follow-ups	6 weeks
Secondary	Study the acute and medium term effects of Kale Superfood on alanine aminotransferase levels	Differences in alanine aminotransferase (ALT, U/L)at baseline and subsequent follow-ups	6 weeks
Secondary	Study the acute and medium term effects of Kale Superfood on aspartate aminotransferase levels	Differences in aspartate aminotransferase (AST, U/L) at baseline and subsequent follow-ups	6 weeks
Secondary	Study the acute and medium term effects of Kale Superfood on HbA1c levels	Differences in Hemoglobin A1c (Hba1C, %), at baseline and subsequent follow-ups	6 weeks
Secondary	Study the acute and medium term effects of Kale Superfood on insulin levels	Differences in insulin (IU/ml) at baseline and subsequent follow-ups	6 weeks
Secondary	Study the acute and medium term effects of Kale Superfood on C-peptide levels	Differences in C-peptide levels (nmol/L) at baseline and subsequent follow-ups	6 weeks