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Completed

NCT Number: NCT04695418

Effectiveness of Rice Germ Supplementation on Body Composition, Metabolic Parameters, Satiating Capacity and Amino Acid Profiles in Obese Postmenopausal Women

Rice germ (RG) may be a safe and effective dietary supplement for obesity in menopause, considering its high protein content and considerable amounts of essential amino acids, good fatty acids, and fiber. This pilot randomized, blinded, parallel group, placebo-controlled pilot trial investigated the effectiveness of four weeks of RG supplementation (25 g twice a day) on body composition, measured by Dual Energy X-Ray Absorptiometry (DXA), as primary outcome, and metabolic parameters, amino acid profiles and satiating capacity, as secondary outcomes, in obese postmenopausal women following a tailored hypocaloric diet (25-30% less than daily energy requirements). Twenty-seven women were randomly assigned to the supplemented group (14) or placebo group (13). There was a significant interaction between time and group for body mass index (BMI) (p<0.0001), waist (p=0.002), and hip circumference (p=0.01), total protein (0.008), albumin (0.005), Homeostasis Model Assessment index (p=0.04), glycine (p=0.002), glutamine (p=0.004), and histidine (p=0.007). Haber's means over time showed a clearly greater feeling of satiety for the supplemented compared to the placebo group. These findings indicate that RG supplementation in addition to a tailored diet counterbalanced the metabolic changes typical of menopause, with improvements in BMI, body composition, insulin resistance, amino acid profiles and satiety.

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Key information

Conditions

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

Age range

50 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Azienda di Servizi alla Persona

Pavia, 27100, Italy

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • obesity (BMI 30-40 kg/m2)
  • age 50-65
  • menopause
  • sedentary women and non-smoking,
  • women who did not drink more than six glasses (one glass: 125 mL) of wine a week and did not drink hard liquor (alcohol content at least 20% alcohol by volume)
  • women who agreed not to take part in any other weight loss program

Exclusion criteria

  • evidence of heart, kidney or liver disease
  • women who met the Diagnostic and Statistical Manual-IV (DSM-V) criteria for a current diagnosis of major depressive disorder
  • taking any medications for weight loss
  • control of cholesterol and triglycerides for anti-inflammatory purposes
  • pregnancy
  • lactating
  • Type 1 diabetes mellitus, irritable bowel disease, celiac disease, chronic pancreatitis
  • antibiotic use in the last three months
  • probiotic/prebiotic treatment in the last four weeks.

Treatment and study plan

Rice germ

Dietary Supplement

The rice germ was taken every day (25 g in the morning with breakfast and 25 g in the afternoon as snacks) for four weeks

Placebo

Combination Product

An isocaloric wheat germ-based supplement was taken every day (25 g in the morning with breakfast and 25 g in the afternoon as snacks) for four weeks

Primary outcomes

  1. Change of body composition

    Time frame: Baseline and 4 weeks

    free fat mass (g), fat mass (g), visceral abdominal tissue (g)

Secondary outcomes

  1. Change of amino acid profiles

    Time frame: Baseline and 4 weeks

    aspartic acid, glutamic acid, alanine, arginine, asparagine, cysteine, citrulline, phenylalanine, glycine, glutamine, isoleucine, histidine, methylhistidine, methionine, ornithine, serine, tyrosine, threonine, tryptophan, valine (micromol/L)

  2. Change of biochemical metabolic parameters

    Time frame: Baseline and 4 weeks

    total serum cholesterol, triacylglycerol, HDL-cholesterol, LDL-cholesterol, apolipoprotein A, apolipoprotein B, glucose, prealbumin, iron, uric acid, creatinine, electrolytes (mg/dl)

  3. Change of biochemical metabolic parameters

    Time frame: Baseline and 4 weeks

    total proteins (g/dl)

  4. Change of biochemical metabolic parameters

    Time frame: Baseline and 4 weeks

    transaminase alanine aminotransferase, aspartate aminotransferase (IU/L)

  5. Change of biochemical metabolic parameters

    Time frame: Baseline and 4 weeks

    gamma glutamyl transferase, lipase and amylase (U/L)

  6. Change of biochemical metabolic parameters

    Time frame: Baseline and 4 weeks

    Homocysteine (micromol/L)

  7. Change of biochemical metabolic parameters

    Time frame: Baseline and 4 weeks

    Vitamin D and folic acid (ng/mL)

  8. Change of biochemical metabolic parameters

    Time frame: Baseline and 4 weeks

    Vitamin B12 (pg/ml)

  9. Change of inflammation markers

    Time frame: Baseline and 4 weeks

    C- Reactive protein (mg/dl)

  10. Change of insulin resistance

    Time frame: Baseline and 4 weeks

    Homeostasis Model Assessment (HOMA) index

  11. Change of satiating capacity

    Time frame: Every day for 4 weeks

    Haber score (point scale)

  12. Change of anthropometric measures

    Time frame: Baseline and 4 weeks

    weight (kg)

  13. Change of anthropometric measures

    Time frame: Baseline and 4 weeks

    Body mass index (Kg/m2)

  14. Change of anthropometric measures

    Time frame: Baseline and 4 weeks

    calf circumference, waist circumference, arm circumference, hip circumference (cm)

Sponsors and collaborators

Lead sponsor

Azienda di Servizi alla Persona di Pavia

Other

Registry information

Official study title

Effectiveness of Rice Germ Supplementation on Body Composition, Metabolic Parameters, Satiating Capacity and Amino Acid Profiles in Obese Postmenopausal Women: a Pilot Randomized Controlled Clinical Trial

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jan 5, 2021
Registry last updated
Jan 5, 2021

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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