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NCT Number: NCT04904601

Freeze-dried Kale to Reduce Metabolic Risk in Saudi Subjects

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.

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Key information

Conditions

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

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Community Health Department, Applied Medical Sciences, King Saud University

Riyadh, Riyadh Region, 11451, Saudi Arabia

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Kale supplement

Dietary Supplement

Kale (blanched freeze-dried Kale) group1

Peas supplement

Dietary Supplement

placebo (Blanched Freeze-dried Peas) group2

Primary outcomes

  1. Study the acute-term effects of freeze-dried Kale in lipid profile of obese, non-T2DM women

    Time frame: 2 weeks

    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. Study the medium-term effects of freeze-dried Kale in lipid profile of obese, non-T2DM women

    Time frame: 4 weeks

    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.

Secondary outcomes

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

    Time frame: 6 weeks

    Differences in body mass index (BMI, kg/m2) at baseline and subsequent follow-ups

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

    Time frame: 6 weeks

    Differences in fasting glucose (mmol/l), at baseline and subsequent follow-ups

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

    Time frame: 6 weeks

    Differences in alanine aminotransferase (ALT, U/L)at baseline and subsequent follow-ups

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

    Time frame: 6 weeks

    Differences in aspartate aminotransferase (AST, U/L) at baseline and subsequent follow-ups

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

    Time frame: 6 weeks

    Differences in Hemoglobin A1c (Hba1C, %), at baseline and subsequent follow-ups

  6. Study the acute and medium term effects of Kale Superfood on insulin levels

    Time frame: 6 weeks

    Differences in insulin (IU/ml) at baseline and subsequent follow-ups

  7. Study the acute and medium term effects of Kale Superfood on C-peptide levels

    Time frame: 6 weeks

    Differences in C-peptide levels (nmol/L) at baseline and subsequent follow-ups

Sponsors and collaborators

Lead sponsor

Chair for Biomarkers of Chronic Diseases

Other

Collaborators

  • King AbdulAziz City for Science and Technology

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
May 27, 2021
Registry last updated
Feb 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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