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

Azienda di Servizi alla Persona di Pavia

Status: Completed

Conditions: Obesity

Treatments: Combination Product: Placebo; Dietary Supplement: Rice Germ

Study type: Interventional

Funder types: Other

Identifiers

NCT04695418

1402/22052019

Details and patient eligibility

About

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.

Enrollment: 27 patients

Sex: Female

Ages: 50 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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27 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

an isocaloric wheat germ-based supplement

Treatment:

Combination Product: Placebo

Rice Germ

Active Comparator group

Treatment:

Dietary Supplement: Rice Germ