Freeze-dried Kale to Reduce Metabolic Risk in Saudi Subjects

NCT04904601 | Completed DMC

• 1 other identifier: 20121503
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Obesity; Metabolic Disease

Keywords

Kale supplement; Microbiome; Obesity; Endotoxin

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (7)

• Study the acute and medium term effects of Kale Superfood on BMI

  6 weeks

• Study the acute and medium term effects of Kale Superfood on glucose levels

  6 weeks

• Study the acute and medium term effects of Kale Superfood on alanine aminotransferase levels

  6 weeks

• Study the acute and medium term effects of Kale Superfood on aspartate aminotransferase levels

  6 weeks

• Study the acute and medium term effects of Kale Superfood on HbA1c levels

  6 weeks

Study Arms (2)

Experimental Group: Kale

ACTIVE COMPARATOR

This group will be given one scoop of powder of (Kale) three times a day for a total of 10g/day for 6 weeks.

Dietary Supplement: Kale supplement

Placebo Group: Green Peas

PLACEBO COMPARATOR

This group will be given one scoop of powder of (Green Peas) three times a day for a total of 10g/day for 6 weeks.

Dietary Supplement: Peas supplement

Interventions

Kale supplement DIETARY_SUPPLEMENT

Kale (blanched freeze-dried Kale) group1

Experimental Group: Kale

Peas supplement DIETARY_SUPPLEMENT

placebo (Blanched Freeze-dried Peas) group2

Placebo Group: Green Peas

Eligibility Criteria

• Age: 18 Years - 40 Years
• Gender Eligibility Details: Women only
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Obese (BMI 30-40Kg/m2 and above)
• Aged 18-40 years
• Saudi nationality
• Female

You may not qualify if:

• 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

Sponsors & Collaborators

• Chair for Biomarkers of Chronic Diseases: lead
• King AbdulAziz City for Science and Technology: collaborator

Study Sites (1)

Community Health Department, Applied Medical Sciences, King Saud University

Riyadh, Riyadh Region, 11451, Saudi Arabia

Location

MeSH Terms

Conditions

Obesity; Metabolic Diseases

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Both the participant and investigator are blinded. Randomization and blinding will be done by a third party.
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Kale (blanched freeze-dried Kale) group 1 (N=50 adult obese Saudi women) Placebo (Blanched Freeze-dried Peas) group 2 (N=50 adult obese Saudi women)

Study Record Dates

• First Submitted: April 18, 2021
• First Posted: May 27, 2021
• Study Start: September 15, 2021
• Primary Completion: September 28, 2022
• Study Completion: September 28, 2022
• Last Updated: February 13, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

SA (1)